L.S. 437.47(R) Regolamenti dwar Prodotti Mediċinali Veterinarji Imħas

VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 1 SUBSIDIARY LEGISLATION 437.47 VETERINARY MEDICINAL PRODUCTS REGULATIONS * 12th November, 2004 LEGAL NOTICE 469 of 2004, as amended by Legal Notices 82 of 2006, and 23 and 360 of 2009, 179 and 470 of 2021. TITLE I 1.

(1)The title of these regulations is the Veterinary Medicinal Products Regulations. Title and scope. Amended by: L.N. 82 of 2006.

(2)The scope of these regulations is to implement the rules laid down under European Union Council Directive 2001/82/EEC on the European Community code relating to veterinary medicinal products.

(3)(

a)These regulations shall apply to veterinary medicinal products, including pre-mixes for medicated feedingstuffs, intended to be placed on the market in Malta and prepared industrially or by a method involving an industrial process. (
b)In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a "veterinary medicinal product" and within the definition of a product covered by other Community legislation, the provisions of these regulations shall apply. (
c)Notwithstanding paragraph (a), these regulations shall also apply to active substances used as starting materials to the extent set out in regulations 44, 44A, 45 and 72 and additionally to certain substances that may be used as veterinary medicinal products that have anabolic, anti-infectious, anti-parasitic, antiinflammatory, hormonal or psychotropic properties to the extent set out in regulation 61. 2. For the purposes of these regulations, the following terms shall have the following meanings "active substance" means any substance or mixture of substances intended to be used in the manufacture of a veterinary medicinal product and that product, when used in its production, becomes an active ingredient of that product; "advertising of veterinary medicinal products" means the making of a representation in any form in connection with veterinary medicinal products in order to promote the supply, distribution, sale, prescription or use of veterinary medicinal products and comprising also the supply of samples and sponsorships; *These regulations have been repealed by Legal Notice 335 of 2024. Definitions. Amended by: L.N. 82 of 2006; L.N. 179 of 2021. 2 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS "Agency" means the European Medicines Agency established by Regulation (EC) No 726/2004; "Adverse reaction" means a reaction to a veterinary medicinal product which is harmful and unintended and which occurs at doses norm ally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function; "the Commission" means the Commission in accordance with Council Decision 1999/468/EC of 28th June, 1999; Cap. 437. "Director for Veterinary Services" means the Director for Veterinary Services as defined in the Veterinary Services Act, and includes, to the extent of the authority given, to any officer authorised by him, in writing, to act on his behalf for any of the purposes mentioned in the Veterinary Services Act. Whenever in the text the words "Veterinary Services" are used these should be construed as referring to the "Director for Veterinary Services";"; and immediately thereafter there shall be added the following new definitions: "dispensing" means the sale or supply of veterinary medicinal products. The products are sold or supplied from a veterinary pharmacy or by a veterinary surgeon in licensed veterinary establishments or during out calls; "European Union" means the European Union as referred to in the Treaty; "Committee for Veterinary Medicinal Products" hereinafter referred to as "the Committee" means part of the Agency set up to facilitate the adoption of common decisions on the authorisation of veterinary medicinal products on the basis of the scientific criteria of quality, safety and efficacy. This Committee shall be appointed in accordance with article 31 of European Union Council Directive 2001/82/EC; "Common name" means the international non-proprietary name recommended by the World Health Organisation, or, if one does not exist, the usual common name; "the Community" means the European Community as established under the Treaty establishing the European Community; Cap. 449. "food" shall have the same meaning as assigned to it in the Food Safety Act; "Homeopathic veterinary medicinal product" means any veterinary medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the Pharmacopoeias currently used officially in Member States. A homeopathic veterinary medicinal product may contain a number of principles; "Human adverse reaction" means a reaction which is noxious and unintended and which occurs in a human being following exposure to a veterinary medicine; "Immediate packaging" means the container or any other form of VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 packaging that is in direct contact with the medicinal product; "Immunological veterinary medicinal product" means a veterinary medicinal product administered to animals in order to produce active or passive immunity or to diagnose the state of immunity; "imported veterinary medicinal products" means veterinary medicinal products obtained from a source outside the EU; "licensed veterinary establishment" has the same meaning as assigned to it in the Private Veterinary Establishments (Licensing) Regulations; "Labelling" means information on the immediate or outer packaging; "Medicated feeding stuffs" means any mixture of a veterinary medicinal product or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing, because of its curative or preventive properties or other properties as a veterinary medicinal product; Medicinal products" shall have the same meaning as is assigned to in the Medicines Act; "Member State" me ans a State w hich is a member o f the European Union; ""Metaphylactic" means the administration of a veterinary medicinal product or a medicinal product to a group of animals after a diagnosis of clinical disease in part of the group has been established, with the aim of treating the clinically sick and controlling the spread of the disease to animals in close contact and at risk and which may already be sub clinically infected; "Name of veterinary medicinal product" means the name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder; "Narcotic drugs" means the substances present on the Yellow List prepared by the International Narcotics Control Board in accordance with the Single Convention on Narcotic Drugs, 1961, Protocol of 25 March 1972 amending the Single Convention on Narcotic Drugs, 1961; "Off-label use" means the use of a veterinary medicinal product when such use is not in accordance with the summary of the product characteristics, including the misuse and serious abuse of the product; "Outer packaging" means the packaging into which is placed the immediate packaging; "Package leaflet" means the leaflet containing information for the user that accompanies the medicinal product; "Periodic safety update reports" means the periodical reports containing the records referred to in regulation 68. S.L. 437. 106 . Cap. 458. 3 4 Cap. 464. [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS "Pharmacist" means a person who is enlisted in the Register of Pharmacists kept by the Pharmacy Council in terms of article 17 of the Health Care Professions Act; "placing under official control" means the detaining of any article by the Director for Veterinary Services in order to permit the accomplishment of any of its functions; "Post-marketing surveillance studies" means the pharmacoepidemiological study or a clinical trial carried out in a c c o r d a n c e w i t h t h e t e r m s o f t h e m a r k e t i n g a u t h o r i sa t i o n , conducted with the aim of identifying and investigating a safety hazard relating to an authorised veterinary medicinal product; "Premix for medicated feeding stuffs" means any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feeding stuffs; "prescribing" means the act of preparing a veterinary prescription by a veterinary surgeon being it on paper or electronic media; "preventive use of an antimicrobial agents" means the administration of antimicrobial agents to healthy animals to prevent infections to compensate for inadequate good farming practice; "procurement" means the act of acquiring, for profit or not, a veterinary medicinal product, or part thereof, from a Member State of the European Union; Cap. 31. "prophylactic administration of antimicrobials" means the administration of a veterinary medicinal product or a medicinal product to an animal or group of animal before clinical signs of a disease, in order to prevent the occurrence of disease or infection: "psychotropic drugs" means the substances listed in the Third schedule to the Medical and Kindred Professions Ordinance and those substances listed on the Green List prepared by International Narcotics Control Board in accordance with the Convention on Psychotropic Substances of 1971; "Representative of the marketing authorisation holder" means the person, commonly known as local representative, designated by the marketing authorisation holder to represent him in Malta; "Risk/benefit balance" means an evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the risks as defined above; "Risks relating to use of the product" means: - any risk relating to the quality, safety and efficacy of the veterinary medicinal products as regards animal or human health; - any risk of undesirable effects on the environment; "Serious adverse reaction" means an adverse reaction which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly and, or birth defect, or which results in permanent or prolonged signs in the animals treated; "source country" means a Member State of the EU or a country in the European Economical Area from where the veterinary medicinal VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 products referred to in regulation 7 can be procured; "Strength" means the content of active substances, expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form; "Substance" means any matter irrespective of origin which may be (
a)human, e.g. human blood and human blood products; (
b)animal, e.g. micro organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products; (
c)vegetable, e.g. micro organisms, plants, parts of plants, vegetable secretions, extracts; (
d)chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis; "Suitably Qualified Persons" means that person who has a qualification in a veterinary science and included in one of the para-veterinary professions mentioned in the Act; "Third Country" means a State which is not a Member within the European Community; "Unexpected adverse reaction" means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of the product characteristics; "Veterinary medicinal product" means: (
a)any substance or combination of substances presented as having properties for treating or preventing disease in animals; or (
b)any substance or combination of substances which may be used in or administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis; "veterinary surgeon" means a person as described and regulated by article 43 of the Act and whose name is entered in the Register of Veterinary Surgeons’ Register, or that person, coming from any other Member State of the European Union, whose name is entered in the relevant register kept by the relevant body of that Member State which regulates the profession of Veterinary surgeons. In the latter case the provisions of the Mutual Recognition of Qualifications Act and the Services (Internal Market) Act shall apply; "Veterinary prescription" means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law. "Veterinary Services" means the competent authority within the territory of Malta as established under article 2 of the Veterinary Services Act; Cap. 451. Cap. 500. Cap. 464. 5 6 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS "veterinary wholesale dealer" means that person authorised to carry out wholesale distribution of veterinary medicinal products; "Withdrawal period" means the period necessary between the last administration of the veterinary medicinal product to animals, under normal conditions of use and in accordance with the provisions of these regulations, and the production of foodstuffs from such animals, in order to protect public health by ensuring that such foodstuffs do not contain residues in quantities in excess of the maximum residue limits for active substances laid down pursuant to European Union Regulation (EEC) No 2377/90; "Wholesale dealing in veterinary medicinal products" means any activity which includes the purchase, sale, import, export, or any other commercial transaction in veterinary medicinal products, whether or not for profit, except for (
a)the supply by a manufacturer of veterinary medicinal products manufactured by himself, or, (
b)retail supplies of veterinary medicinal products by persons entitled to carry out such supplies in accordance with regulation 59. TITLE II Cap. 437. Applicability. Substituted by: L.N. 82 of 2006. Amended by: L.N. 179 of 2021. 3.

(1)These regulations shall not apply to: (

a)medicated feedingstuffs as defined in European Union Council Directive 90/167/EEC laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the European Union; (
b)inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or the animals of that holding in the same locality; (
c)veterinary medicinal products based on radio-active isotopes; (
d)any additives covered by European Union Council Directive 70/524/EEC concerning additives in feedingstuffs where they are incorporated in animal feedingstuffs and supplementary animal feedingstuffs in accordance with that Directive; and However, medicated feedingstuffs referred to in paragraph (
a)may be prepared only from pre-mixes that have been authorised under these regulations.

(2)Except for the provisions on the possession, prescription, dispensing and administration of veterinary medicinal products, these regulations shall not apply to: (

a)any medicinal product prepared in a pharmacy in accordance with a veterinary prescription for an individual animal or a small group of animals, VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 7 commonly known as the magistral formula; and (
b)any medicinal product prepared in a pharmacy in accordance with the prescriptions of a Pharmacopoeia and intended to be supplied directly to the end-user, commonly known as the officinal formula. 4.

(1)The Director may provide that these regulations shall not apply to non-inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or the animals of that holding in the same locality.

(2)In the case of veterinary medicinal products intended solely for aquarium fish, cage birds, homing pigeons, terrarium animals, small rodents, and ferrets and rabbits kept exclusively as pets, Malta may permit exemptions from the provisions in regulations 5 to 8, provided that such products do not contain substances the use of which requires veterinary control and that all possible measures are taken to prevent unauthorised use of the products for other animals.

(3)In order to be granted the exemption for the veterinary medicinal product referred to in this sub-regulation applicants shall submit an application with the Veterinary Services.

(4)In order to qualify under the exemption described in this sub-regulation

(2)the product must be manufactured by: (

a)the holder of a manufacturing authorisation if manufactured in Malta or in another Member State of the European Union; (
b)the holder of a relevant licence conferring authorisation to manufacture veterinary medicinal products if the product is manufactured in a Third country.

(5)The product must not be classified as requiring a veterinary prescription.

(6)The manufacturer, importer, wholesale dealer or retailer of a veterinary medicinal product shall declare that he will notify the Veterinary Services within fifteen

(15)days of learning of any serious adverse reactions in accordance with sub-regulations

(2)and

(3)of regulation 68. A record of each adverse reaction and serious adverse reaction must be maintained on becoming aware of it. The records shall be kept for five

(5)years.

(7)The Veterinary Services shall prepare and publish a list of active substances that can be used in veterinary medicinal products authorised under sub-regulation

(2), specifying the species of nonfood producing animals for which it is approved and may specify how the active substance or a product containing the active substances to be administered. Non-inactivated immunological veterinary medicinal products. Amended by: L.N. 82 of 2006; L.N. 179 of 2021. 8 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS

(8)The Veterinary Services may decide not to apply the provisions of this Regulation to a previously exempted product if any one or more of the following occur: (

a)serious adverse reactions are reported; (
b)it is demonstrated, at any time after authorisation, that the substance is carcinogenic, genotoxic or that it shows developmental toxicity (including teratogenicity); (
c)the product contain active substances that are reclassified as narcotic or psychotropic substances; (
d)any one of the ingredient/s in the product is/are not included anymore in the list mentioned in paragraph (
d)of sub-regulation

(3); (e) it is reported and is verified by the Veterinary Services that the product is not being used on the animals mentioned in sub-regulation

(2);

(9)The product authorised under sub-regulation

(2)shall be c l e a r l y l a b e l l e d a s b e i n g e x e m p t f r om t h e r e q u i r e m en t s o f regulations 5, 6, 7 and 8 in relation to a Marketing Authorisation. The information obtainable from the whole pack must at least show the following details: (

a)the name of the veterinary medicinal product; (
b)the pharmaceutical dosage form; (
c)the name and strength of each active substance; (
d)the route of administration; (
e)the batch number; (
f)the expiry date; (
g)a sentence to the effect of "For administration on nonfood producing animals only" authorised in accordance to regulation 4

(2)of these regulations; (

h)the target species; (
i)storage instructions; (
j)the shelf-life after the immediate packaging has been opened for the first time; (
k)therapeutic indications; (
l)contra-indications; (
m)interaction with other medicines and other forms of interaction; (
n)dosage instructions.

(10)If there is sufficient room on the label, the information may be present only on it without the need of a package leaflet. The information must be conveyed in a clear and legible manner.

(11)The provisions of sub-regulation 5 shall come into force on the 1st November 2021. VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 4A.

(1)A veterinary medicinal product may be obtained from any country and administered to animals for research purposes in accordance with article 53

(3)of the Veterinary Services Act.

(2)The veterinary medicinal products authorised according this regulation may be exempt from the provisions of regulations 5, 6, 7 and 8.

(3)The veterinary medicinal products shall only be used in authorised research facilities which are in conformity with the Animal Welfare Act and the Protection of Animals for Scientific Purposes Regulations. Veterinary medicinal products for research purposes. Added by: L.N. 179 of 2021. Cap. 437. Cap. 439. S.L. 439. 13.

(4)(a) In order to be allowed to carry out the activity mentioned in sub-regulation

(1)a person, herein referred to as the "applicant for a veterinary medicinal product to be used for research purposes", shall submit an application with the Veterinary Services. If the application is positively completed a licence for Research Purposes shall be issued. The Veterinary Services shall make, modify, add or remove any terms and conditions pertaining to the licence that it may deem fit in light of scientific advancements or new information that may emerge on particular substances or ingredients contained in the veterinary medicinal products used for research purposes. (

c)The holder of the licence for a veterinary medicinal product to be used for research purposes shall utilise a product or administer it to a test animal only under the terms and conditions set out under the Animal Welfare Act. (
b)(
d)The holder of the licence for a veterinary medicinal product to be used for research purposes who becomes aware of any serious adverse reactions on the animal or on the person administering it shall report the reaction to the Veterinary Services within fifteen

(15)days from the day the serious adverse reaction was discovered. (

e)Food for human consumption can be taken from test animals only in accordance with regulation 86 and with the prior approval of the Veterinary Services. (
f)The application submitted by the applicant shall be granted without prejudice to any licence or permit that the applicant may need to obtain from other departments and directorates in order to engage in the indicated research activity. (
g)The applicant for a veterinary medicinal product or holder of the licence is subject to official inspections by the Veterinary Services on the premises and the activities undertaken within the premises. (
h)The Veterinary Services shall set out the criteria for veterinary medicinal product which are obtained in 9 Cap. 439. 10 [ S.L.437.47 Samples and demonstration packs of veterinary medicinal products. Added by: L.N. 179 of 2021. VETERINARY MEDICINAL PRODUCTS accordance with sub-regulation

(1)and make them public. 4B.

(1)Veterinary medicinal products may be exempted from the provisions in regulations 5 to 8 if it can be demonstrated that the products are veterinary samples or demonstration packs distributed to veterinary surgeons or pharmacists by veterinary wholesale distributors.

(2)The products referred to in sub-regulation

(1)may be used under the following conditions: (

a)they are distributed for free to persons authorised to receive them or are exhibited during conferences or similar activities which are held for intended for veterinary surgeons and/or pharmacists; (
b)they bear a label printed "Free sample/Demonstration pack – Not for sale"; (
c)the unit pack should not contain more than: (
i)(
ii)(iii) (
iv)(
v)(
vi)Obligations relating to veterinary medicinal products. Added by: L.N. 179 of 2021. Cap. 437. Veterinary medicinal products obtained from other countries for personal use. Added by: L.N. 179 of 2021. 50 units for capsules/tablets; 10 units for injections and spot-ons 300g for powders 3L for liquids 5 units for intra-mammary tubes any other measurement as established by the Veterinary Services for all other Pharmaceutical forms (
d)the information provided with the samples shall not be promotional in nature; (
e)the maximum period of time the authorised veterinary wholesale dealer can procure a product from a Member State of the European Union as a free sample is one

(1)year from the first consignment thereof; (f) if any product authorised in accordance with the provisions of sub-regulation

(1)is administered to a food producing animals, that animal is excluded permanently from the food chain. 4C. Any authorisation issued under regulations 4

(2), 4A and 4B, shall be deemed to be a Marketing Authorisation for the purposes of articles 38, 53 and 57 of the Veterinary Services Act. 4D.

(1)Veterinary medicinal products may be exempted from the provisions in regulations 5 to 8 when the products are procured from a Member State of the European Union or imported from a Third country under the terms and conditions mentioned in subregulation

(2).

(2)The following terms and conditions shall apply: VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 (

a)the products shall not be re-sold for monetary gain; (
b)the products shall not be transferred to other third parties unless such transfer is authorised by the Veterinary Services; (
c)this provision is not applicable to psychotropic drugs, narcotic drugs for all animals and in the case of food producing animals also the substances listed in Group A in Schedule I of Measures to monitor certain Substances and Residues thereof in Live Animals and Animal Products Rules and Table II of Regulation (EU) 37/2010; (
d)the quantity of products obtained shall be proportional to the dosage regime of the condition it will be used for; (
e)the quantity of products which is allowed entry in Maltese territory shall cover the period indicated as the duration of treatment in the product’s specifications or on the veterinary surgeons ‘s veterinary prescription. However, products intended to be used for recurrent or chronic conditions can be allowed entry in Malta several times a year, provided that cogent evidence that demonstrate the benefits obtained by the regular use of the products can be provided; (
f)the individuals shall be required to provide a veterinary prescription for products classified as requiring such a prescription in the country from where they are obtained or for similar veterinary medicinal products in Malta: Provided that the Veterinary Services may still ask for such a veterinary prescription even if the products are classified as not requiring a veterinary prescription in the country from where they are obtained; (
g)only products that do not contain animal by-products which are derived from high risk areas where certain diseases may be, or suspected to be, present or prevalent, can be obtained; (
h)only products that do not contain ingredients that are classified as illegal in Malta and do not have banned indications in Malta can be obtained; (
i)only appropriately labelled products which give clear indication of the nature of the ingredient/s within can be obtained; (
j)food producing animals administered with the veterinary medicinal products authorised in accordance with this regulation can only be consumed by the person getting the veterinary medicinal products, or by consenting members of the same household. The appropriate withdrawal period shall apply; S.L. 437. 58. 11 12 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS (
k)before a decision on antimicrobial veterinary medicinal products and products that have a hormonal activity is taken, a risk assessment shall be prepared by the Veterinary Services in a timely manner; (
l)the decision by the Veterinary Service is without prejudice to any license or permit that the person getting the veterinary medicinal products may need to obtain under other regulations of the same or of different department.

(3)The veterinary services shall decide on the release, placing under official control or destruction of veterinary medicinal products, or the products presumed to be veterinary medicinal products, if and when these are intercepted at the various entry control points throughout the territory of Malta.

(4)Pursuant to sub-regulation

(3), the Veterinary Services shall keep a record of all the opinions or decisions taken. These records shall be kept by the Veterinary Services for a period of not less than ten

(10)years.

(5)The Veterinary Services shall set out the criteria for veterinary medicinal product which can be obtained in accordance with sub-regulation

(1)and make them public: Provided that the provisions of this regulations shall also apply to veterinary medicinal products that are brought in the territory of Malta as a bona fide donation for use on animals kept in the approved sanctuary subject to the donation on condition that the veterinary services is pre-notified of such a request with the name, quantity and nature of the products, and the names and addresses of the donator, the recipient and the animal sanctuary involved. TITLE III MARKETING CHAPTER 1 Marketing authorisation Marketing authorisation issued by the Veterinary Services. Substituted by: L.N. 82 of 2006. 5.

(1)No veterinary medicinal product may be placed on the market of Malta unless a marketing authorisation has been granted by the Veterinary Services in accordance with these regulations or a marketing authorisation has been granted in accordance with European Union Regulation (EC) No 726/2004. When a veterinary medicinal product has been granted an initial authorisation in accordance with the first paragraph, any additional species, strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions, shall also be granted an authorisation in accordance with the first paragraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of regulation 13

(1).

(2)The marketing authorisation holder shall be responsible for VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 13 the marketing of the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of his legal responsibility. 6.

(1)A veterinary medicinal product may not be the subject of a marketing authorisation for the purpose of administering it to one or more food-producing species unless the pharmacologically active substances which it contains appear in Annexes I, II or III to European Regulation (EEC) No 2377/90. Active substances in veterinary medicinal product. Substituted by: L.N. 82 of 2006.

(2)If an amendment to the Annexes to Regulation (EEC) No 2377/90 so warrants, the marketing authorisation holder or, where appropriate, the Veterinary Services shall take all necessary measures to amend or revoke the marketing authorisation within sixty days of the date on which the amendment to the Annexes to that Regulation was published in the Official Journal of the European Union.

(3)By way of derogation from subregulation

(1), a veterinary medicinal product containing pharmacologically active substances not included in Annexes I, II or III to European Regulation (EEC) No 2377/90 may be authorised for particular animals of the equidae family that have been declared, in accordance with European Commission Decision 93/623/EEC establishing the identification doc ument (pa ssport) accompanying r egiste red equidae and European Commission Decision 2000/68/EC amending Decision 93/623/EEC and establishing the identification of equidae for breeding and production, as not being intended for slaughter for human consumption. Such veterinary medicinal products shall neither include active substances that appear in Annex IV to European Regulation (EEC) No 2377/90 nor be intended for use in the treatment of conditions, as detailed in the authorised Summary of Product Characteristics, for which a veterinary medicinal product is authorized for animals of the equidae family. 7. Where the health situation so requires, the Veterinary Services may authorise the marketing or administration to animals of veterinary medicinal products which have been authorised by a n o t h e r M e m b e r St a t e referred to as the "source country i n accordance with European Union Council Directive 2001/82/EC. Authorisation of the marketing or administration to animals of veterinary medicinal products. Amended by: L.N. 179 of 2021. 7A.

(1)In order to be allowed to market the products under regulation 7, a person, herein referred to as the "applicant for the registration of veterinary medicinal product" under regulation 7, shall submit an application to the Veterinary Services. Registration of veterinary medicinal products according to regulation 7. Added by: L.N. 179 of 2021.

(2)Upon a reasoned request the Veterinary Services may decide that regulations 60

(10)and 60

(11)on the legal category of Veterinary medicinal products and regulation 51

(4)do not apply to registrations granted under regulation 7.

(3)may: Before granting such a registration the Veterinary Services 14 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS (

a)request the competent authority in the source country to furnish a copy of the Marketing Authorisation in force; (
b)ensure that the entity applying for a registration in accordance with regulation 7 is a legally established company in the European Union or European Economic Area; (
c)notify the Marketing Authorisation Holder of its intention to grant a registration according to regulation 7 when the Registration Holder is not the same entity as the Marketing Authorisation Holder in the country of source; (
d)request the applicant for a registration in accordance with regulation 7 to furnish an authenticated copy of the Marketing Authorisation in force: Provided that it is not possible for the applicant to provide an authenticated copy of the Marketing Authorisation he shall be requested to provide other proof of an existing Marketing Authorisation in the country of source. (
e)request from the applicant data on the impact of the product on the environment in Malta.

(4)The holder of the registration granted in accordance with regulation 7 shall ensure that: (

a)the veterinary medicinal product is in accordance with the current Marketing Authorisation issued in the source country; (
b)notify the veterinary services of any variations to the terms of the Marketing Authorisation approved in the country of source; (
c)there are implemented without any delay actions relating to issues concerning the veterinary medicinal product which have resulted in adverse drug reaction and/or a product or batch recall; (
d)a person is appointed or be himself responsible for the requirements in paragraph (c); (
e)when the applicant is not the Market Authorisation Holder of the product in the source country he shall furnish to the Veterinary Services a letter of access issued by the Market Authorisation Holder granting him the use of the Marketing Authorisation for the purpose of regulation 7: Provided that it is not possible for the applicant to receive a ‘letter of access’ from the Market Authorisation Holder in the country of source the applicant shall be requested to provide proof of the agreement between himself and a duly authorised veterinary wholesale distributor in the country of source; VETERINARY MEDICINAL PRODUCTS (
f)[ S.L.437.47 15 have a system in place for recording and investigation adverse drug reactions and batch or product defects. 8.

(1)In the event of serious epizootic diseases, the Ve t e r i n a r y S e r v i c e s m a y p r o v i s i o n a l l y a l l o w t h e u s e o f immunological veterinary medicinal products without a marketing authorisation, in the absence of a suitable medicinal product and after informing the European Commission of the detailed conditions of use. Serious disease epidemic. Substituted by: L.N. 82 of 2006.

(2)If an animal is being imported from, or exported to, a third country and is thereby subject to specific binding health rules, the Veterinary Services may permit the use, for the animal in question, of an immunological veterinary medicinal product that is not covered by a marketing authorisation in Malta but is authorized under the legislation of the third country. The Veterinary Services shall take all appropriate measures concerning the supervision of the importation and the use of such immunological products. 9. No veterinary medicinal product may be administered to animals unless the marketing authorisation has been issued, except for the tests of veterinary medicinal products referred to in regulation 12

(3)(j) which have been accepted by the competent national authorities, following notification or authorisation, in accordance with the rules in force. Administration of veterinary medicinal product to animals. 10.

(1)The Veterinary Services shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in Malta for a condition affecting a non foodproducing species, by way of exception, the veterinary surgeon responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animal concerned with: Exception granted by the Veterinary Services. Substituted by: L.N. 82 of 2006. Amended by: L.N. 179 of 2021. (

a)a veterinary medicinal product authorised in Malta under these regulations or under European Regulation (EC) No 726/2004 for use with another animal species, or for another condition in the same species; or (
b)if there is no product as referred to in paragraph (
a)(
i)either a medicinal product authorised for human use in Malta in accordance with European Directive 2001/83/EC of the European Parliament and of the European Council or under European Regulation (EC) No 726/2004, (
ii)or, in accordance with specific national measures, a veterinary medicinal product authorised in another Member State in accordance with these regulations for use in the same species or in another species for the condition in question or for another condition; or (
c)if there is no product as referred to in paragraph (b), and within the limits of the law of Malta, a veterinary medicinal product prepared extemporaneously by a pharmacist or a veterinary surgeon in accordance with the terms of a veterinary prescription.The veterinary 16 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS surgeon may administer the medicinal product personally or allow another person to do so under the veterinary surgeon’s responsibility.

(2)By way of derogation from regulation 11, the provisions of subregulation

(1)hereof shall also apply to the treatment by a veterinary surgeon of an animal belonging to the equidae family provided that it has been declared, in accordance with European Commission Decisions 93/623/EEC and 2000/68/EC, as not being intended for slaughter for human consumption.

(3)In the case of a veterinary medicinal product authorised in a no t h e r m e m b e r St a t e , v e t e r i nar y su rg e o ns s ha ll o bt a in an authorisation from the Veterinary Services before getting the product for the administration to the animal.

(4)In case the veterinary medicinal products contain restricted substances resulting from the implementation of the relevant United Nations conventions on narcotic and psychotropic substances, consideration should be given to any special requirement that need to be satisfied before the products could be used.

(5)A veterinary medicinal product or a medicinal product supplied for administration under paragraphs (a), (b) and (c) of subregulation

(1)may only be supplied in accordance with a veterinary prescription from a veterinary surgeon, irrespective of the legal category assigned to the veterinary medicinal product during the Marketing Authorisation procedure.

(6)The veterinary prescription issued under the condition referred to in sub-regulation

(5)shall be marked as such. A statement similar to, or stating the equivalent meaning of, the following statement: "T h is P r o du ct h as b een pr esc r ib ed i n accordance with the Cascade Principle", shall be included on the veterinary prescription.

(7)Unless the veterinary surgeon who prescribed the veterinary medicinal product or medicinal product both supplies the product and administers it to the animal in person, the person supplying it must label it (or ensure that it is labelled) with at least the following information: (

a)the name of the veterinary surgeon who has prescribed the product; (
b)the identification (including the species) of the animal or group of animals; (
c)dosage and administration instructions.

(8)When a veterinary surgeon has recourse to the provisions of regulation 10, the veterinary surgeon shall keep adequate records of the treatment given. The records shall at least contain the particulars mentioned in sub-regulation

(7)and shall be available for inspection by the Veterinary Services for a period of not less than three

(3)years.

(9)When a veterinary surgeon has recourse to the provisions in paragraphs (a), (b) and (c) of sub-regulation

(1), the activity VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 undertaken by the veterinary surgeon is excluded from the scope of the definition of wholesale distribution under a decision to be laid down by the Veterinary Services. 10A.

(1)By way of derogation from regulation 10

(1), where there is no suitable veterinary medicinal product available either as an authorised product in Malta or under the provisions of regulation 10

(1), veterinary surgeons may, under their direct and only personal responsibility, build up a case and expound it to the Veterinary Services. Veterinary surgeon shall provide detailed justifications to their request. The Veterinary Services may where the disease or condition is such that the veterinary medicinal product is likely to be needed as a matter of urgency for the treatment of an animal, allow the importation of a veterinary medicinal product authorised for any non-food producing species from any third country under any conditions it may deem fit. The Veterinary Services shall base its decision on purely scientific grounds and shall take all precautions, in particular for the safety and environmental risks which may be associated with the use of the veterinary medicinal product, before granting the approval for the importation, which importation shall be considered as a once only grant with the possibility for repeated requests, with each request considered as sui generis.

(2)apply. 17 Importation of veterinary medicinal products for non-food animals by veterinary surgeons. Added by: L.N. 179 of 2021. The provisions in regulations 10

(3),

(4),

(5),

(7), and

(8)shall 11.

(1)The Veterinary Services shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in Malta for a condition affecting a foodproducing species, by way of exception, the veterinary surgeon responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animals concerned on a particular holding with: (

a)a veterinary medicinal product authorised in Malta under these regulations or under European Regulation (EC) No 726/2004 for use with another animal species, or for another condition in the same species; or (
b)if there is no product as referred to in paragraph (a), either (
i)a medicinal product for human use authorised in Malta in accordance with European Directive 2001/83/EC or under European Regulation (EC) No 726/2004, or (
ii)a veterinary medicinal product authorised in another Member State in accordance with these regulations for use in the same species or in another food-producing species for the condition in question or for another condition; or (
c)if there is no product as referred to in paragraph (b), and within the limits of the law of Malta, a veterinary medicinal product prepared extemporaneously by a pharmacist or a veterinary surgeon in accordance with the terms of a veterinary prescription. Records and further details to be kept by veterinary surgeon. Substituted by: L.N. 82 of 2006 Amended by: L.N. 179 of 2021. 18 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS The veterinary surgeon may administer the medicinal product personally or allow another person to do so under the veterinary surgeon’s responsibility.

(2)Subregulation

(1)shall apply provided that pharmacologically active substances included in the medicinal product are listed in Annex I, II or III to European Regulation (EEC) No 2377/90, and that the veterinary surgeon specifies an appropriate withdrawal period. Unless the medicinal product used indicates a withdrawal period for the species concerned, the specified withdrawal period shall not be less than: - 7 days for eggs, - 7 days for milk, - 28 days for meat from poultry and mammals including fat and offal, - 500 degree-days for fish meat.

(3)With regard to homeopathic veterinary medicinal products i n w h i c h a c t i v e p r i n c i p l e s fi g u r e i n A n n e x I I t o E u r o p e a n Regulation (EEC) No 2377/90, the withdrawal period referred to in the second paragraph of subregulation

(2)shall be reduced to zero.

(4)When a veterinary surgeon has recourse to the provisions of subregulations

(1)and

(2), he shall keep adequate records of the date of examination of the animals, details of the owner, the number of animals treated, the diagnosis, the medicinal products prescribed, the doses administered, the duration of treatment and the withdrawal periods recommended, and shall make these records available for inspection by the Veterinary Services for a period of at least five years.

(5)Without prejudice to the other provisions of these regulations, Malta shall take all necessary measures concerning the i m p o r t , d i s t r i b u t i o n , d is p e n s i n g o f an d i n f o r m a ti o n o n t he medicinal products which they permit for administration to foodproducing animals in accordance with subregulation

(1)(b)(ii).

(6)In the case of a veterinary medicinal product authorised in another member State, the veterinary surgeons shall obtain an authorisation from the Veterinary Services before procuring the product for the administration to the food producing animal.

(7)In case the veterinary medicinal products contain restricted substances resulting from the implementation of the relevant United Nations conventions on narcotic and psychotropic substances, consideration shall be given to any special requirement that need to be satisfied before the products could be used.

(8)A veterinary medicinal product or a medicinal product supplied for administration under paragraphs (a), (b) and (c) of subr e g u l a t i o n

(1), m a y o n l y b e su p p l i e d i n a c c o r d a nc e w i t h a prescription from a veterinary surgeon, irrespective of the legal category assigned to the veterinary medicinal product in VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 19 accordance with regulation 60.

(9)The prescription issued under the condition referred to in sub-regulation

(8)shall be marked as such. A statement similar to, or stating the equivalent meaning of, the following statement: "This Product has been prescribed in accordance with Cascade Principle", shall be included on the veterinary prescription.

(10)Unless the veterinary surgeon who prescribed the veterinary medicinal product or the medicinal product both supplies the product and administers it to the animal in person, the person supplying it must label it (or ensure that it is labelled) with at least the following information: (

a)the name of the veterinary surgeon who has prescribed the product; (
b)the name and address of the animal owner; (
c)the identification (including the species) of the animal or group of animals; (
d)the date of supply; (
e)dosage and administration instructions; (
f)the withdrawal period, if relevant.

(11)When a veterinary surgeon has recourse to the provisions in sub-regulation

(1)the activity undertaken by the veterinary surgeon is excluded from the scope of the definition of wholesale distribution. 11A.

(1)By way of derogation from regulation 11

(1)and from Article 16

(1)of Regulation (EC) No 470/2009, where there is no suitable veterinary medicinal product available either as an authorised product i n the Malt a o r und er th e p ro visi ons of regulation 11

(1), veterinary surgeon may, under their direct and only personal responsibility, build up a case and expound it to the Veterinary Services. Veterinary surgeons shall provide detailed justifications to their request. The Veterinary Services shall and where the disease or condition is such that the veterinary medicinal product is likely to be needed as a matter of urgency for the treatment of an animal, allow the importation of a veterinary medicinal product authorised for any food producing species from any Third country under any conditions it may deem fit, including the assignment of an appropriate withdrawal period, if applicable. The Veterinary Services shall base its decision on purely scientific grounds and shall take all precautions, in particular for the safety and environmental risks which may be associated with the use of the veterinary medicinal product, before granting the approval for the importation, which importation shall be considered as a once only grant with the possibility for repeated requests, with each request considered as sui generis.

(2)The provisions of sub-regulations

(6),

(7),

(8)and

(10)of regulations 11 shall apply. Importation of veterinary medicinal products for food producing animals by veterinary surgeons. Added by: L.N. 179 of

20 [ S.L.437.47 Marketing authorisation for veterinary medicinal product. Substituted by: L.N. 82 pf
VETERINARY MEDICINAL PRODUCTS 12.

(1)For the purposes of obtaining a marketing authorisation in respect o f a vet erinary med icinal p rodu ct , otherwise than under the procedure established by European Regulation (EC) No 726/2004, an application shall be lodged with the Veterinary Services. In the case of veterinary medicinal products which are intended for one or more food-producing species but whose pharmacologically active substances have not yet been included, for the species in question, in Annexes I, II or III to European Regulation (EEC) No 2377/90, a marketing authorisation may not be applied for until after a valid application has been made for the establishment of maximum residue limits in accordance with that Regulation. At least six months shall elapse between a valid application for the establishment of maximum residue limits and an application for a marketing authorisation. However, in the case of veterinary medicinal products referred to in regulation 6

(3), a marketing authorisation may be a pp li e d f o r wi t ho ut a v a l id a pp li c a t io n i n a c c or d a nc e w it h European Reg ulatio n (EEC) No 2 377/9 0. All the scient ific documentation necessary for the demonstration of the quality, safety and efficacy of the veterinary medicinal product, as provided for in subregulation

(3), shall be submitted.

(2)A marketing authorisation may only be granted to an applicant established in the European Union.

(3)The application for marketing authorisation shall include all the administrative information and scientific documentation necessary for demonstrating the quality, safety and efficacy of the veterinary m edicinal product in question. T he file shall be submitted in accordance with the Schedule and shall contain, in particular, the following information: (

a)name or business name and permanent address or registered place of business of the person responsible for placing the product on the market and, if different, of the manufacturer or manufacturers involved and of the sites of manufacture; (
b)name of veterinary medicinal product; (
c)qualitative and quantitative particulars of all the constituents of the veterinary medicinal product, including its international non-proprietary name (INN) recommended by the WHO, where an INN exists, or its chemical name; (
d)description of the method of manufacture; (
e)therapeutic indications, contra-indications and adverse reactions; (
f)dosage for the various species of animal for which the veterinary medicinal product is intended, its pharmaceutical form, method and route of administration and proposed shelf life; (
g)reasons for any precautionary and safety measures to be taken when storing the veterinary medicinal VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 product, administering it to animals and disposing of waste, together with an indication of potential risks that the veterinary medicinal product might pose to the environment, to human and animal health and to plants; (
h)indication of the withdrawal period in the case of medicinal products intended for food-producing species; (
i)description of the testing methods employed by the manufacturer; (
j)results of: - pharmaceutical (physico-chemical, biological or microbiological) tests, safety tests and residue tests, pre-clinical and clinical trials; tests assessing the potential risks posed by the medicinal product for the environment. This impact shall be studied and consideration shall be given on a case-by-case basis to specific provisions seeking to limit it; (
k)a detailed description of the pharmacovigilance system and, where appropriate, the risk management system that the applicant will put in place; (
l)a summary in accordance with regulation 14 of the product characteristics, a mock-up of the immediate packaging and the outer packaging of the veterinary medicinal product, together with the package leaflet, in accordance with regulations 53 to 55; (
m)a document showing that the manufacturer is authorized in his own country to produce veterinary medicinal products; (
n)copies of any marketing authorisation obtained in another Member State or in a third country for the relevant veterinary medicinal product, together with a list of those Member States in which an application for authorisation submitted in accordance with these regulations is under examination. Copies of the summary of the product characteristics proposed by the applicant in accordance with regulation 14 or approved by the Veterinary Services in accordance with regulation 25 and copies of the package insert proposed, details of any decision to refuse authorisation, whether in the European Union or a third country and the reasons for that decision. All this information shall be updated on a regular basis; (
o)proof that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the European Union or in a third country; 21 22 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS (
p)in the case of veterinary medicinal products intended for one or more food-producing species and containing one or more pharmacologically active substances not yet included, for the species in question, in Annexes I, II or III to European Regulation (EEC) No 2377/90, a document certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with the aforementioned Regulation. The documents and particulars relating to the results of the tests referred to in paragraph (
j)shall be accompanied by detailed and critical summaries, drawn up as specified in regulation 15. Derogation. Substituted by: L.N. 82 of 2006. 13.

(1)By way of derogation from regulation 12

(3)(j), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of the safety and residue tests or of the preclinical and clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under regulation 5 for not less than eight years in a Member State or the European Union. A generic veterinary medicinal product authorized pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product. The first subregulation shall also apply when the reference medicinal product was not authorised in the Member State in which the application for the generic medicinal product is submitted. In this case, the applicant shall indicate in the application the Member State in which the reference medicinal product is or has been authorised. At the request of the Veterinary Services, the competent authority of the other Member State shall transmit, within a period of one month, confirmation that the reference medicinal product is or has been authorized together with the full composition of the reference product and if necessary other relevant documentation. However, the ten-year period provided for in the second paragraph shall be extended to thirteen years in the case of veterinary medicinal products for fish or bees or other species designated in accordance with the procedure referred to in Article 89

(2)of European Union Council Directive 2004/28 EC.

(2)For the purposes of this regulation: (

a)"reference medicinal product" shall mean a product authorised within the meaning of regulation 5 in accordance with the provisions of regulation 12; (
b)"generic medicinal product" shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 considered to be the same active substance, unless they differ significantly in properties with regard to safety and, or efficacy. In such cases, additional information intended to provide proof of the safety and, or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies neednot be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines.

(3)In cases where the veterinary medicinal product does not fall under the definition of a generic medicinal product set out in subregulation

(2)(b) or where bio-equivalence cannot be demonstrated through bioavailability studies or in the case of changes to the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration vis-à-vis the reference medicinal product, the results of the appropriate safety and residue tests and pre-clinical tests or clinical trials shall be provided.

(4)Where a biological veterinary medicinal product which is similar to a reference biological veterinary medicinal product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or in manufacturing processes of the biological veterinary medicinal product and the reference biological veterinary medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in the Schedule and the related detailed guidelines. The results of other tests and trials from the reference medicinal product’s dossier shall not be provided.

(5)In the case of veterinary medicinal products intended for one or more food-producing species and containing a new active substance that has not been authorised in the European Union by 30 April 2004 the ten-year period provided for in the second paragraph of subregulation

(1)shall be extended by one year for each extension of the marketing authorisation to another food-producing species, if it is authorised within the five years following the granting of the initial marketing authorisation. This period shall not, however, exceed a total of thirteen years, for a marketing authorisation for four or more foodproducing species. The extension of the ten-year period to eleven, twelve, or thirteen years for a veterinary medicinal product intended for foodproducing species shall be granted only if the marketing authorisation holder also originally applied for determination of the maximum residue limits established for the species covered by the authorisation. 23 24 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS

(6)Conducting the necessary studies, tests and trials with a view to the application of subregulations

(1)to

(5)and the consequential practical requirements shall not be regarded as contrary to patent-related rights or to supplementary-protection certificates for medicinal products. Derogation. Added by: L.N. 82 of 2006. 13A.

(1)By way of derogation from regulation 12

(3)(j), and without prejudice to the law on the protection of industrial and commercial property, the applicant shall not be required to provide the results of safety and residue tests or of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the veterinary medicinal product have been in well-established veterinary use within the European Union for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in the Schedule. In that event, the applicant shall provide appropriate scientific literature.

(2)The assessment report published by the Agency following the evaluation of an application for the establishment of maximum residue limits in accordance with European Regulation (EEC) No 2377/90 may be used in an appropriate manner as literature, particularly for the safety tests.

(3)If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies in acco rdance w ith European Regulation (EEC) No 2377\90, together with further clinical trials, it shall not be permissible for a third party to use such studies or such trials pursuant to regulation 13, for a period of three years from the grant of the authorization for which they were carried out. Active substances. Added by: L.N. 82 of 2006. 13B. In the case of veterinary medicinal products containing active substances used in the composition of authorized veterinary medicinal products but not hitherto used in combination for therapeutic purposes, the results of safety and residue tests, if necessary, and new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with regulation 12

(3)( j), but it sh all not b e n ecessary to provide scien tific references relating to each individual active substance. Use of documentation. Added by: L.N. 82 of

13C. After the marketing authorisation has been granted, the marketing authorisation holder may allow use to be made of the pharmaceutical, safety and residues, pre-clinical and clinical documentation contained in the file for the veterinary medicinal product with a view to examining a subsequent application for a veterinary medicinal product having the same qualitative and quantitative composition in active substances and the same pharmaceutical form. Derogation. Added by: L.N. 82 of
13D. By way of derogation from regulation 12

(3)(j), and in exceptional circumstances with respect to immunological veterinary medicinal products, the applicant shall not be required to provide the results of certain field trials on the target species if these trials cannot be carried out for duly substantiated reasons, in particular on account of other European Union provisions. VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 14. The summary of the product characteristics shall contain, in the order indicated below, the following information:

(1)name of the veterinary medicinal product followed by the strength and the pharmaceutical form;

(2)qualitative and quantitative composition in terms of the active substances and constituents of the excipient, knowledge of which is essential for proper administration of the medicinal product. The usual common name or chemical description shall be used;

(3)pharmaceutical form;

(4)clinical particulars: (

i)(
ii)(iii) (
iv)(
v)(
vi)target species, indications for use, specifying the target species, contra-indications, special warnings for each target species, special precautions for use, including special precautions to be taken by the person administering the medicinal product to the animals, adverse reactions (frequency and seriousness), (vii) use during pregnancy, lactation or lay, (viii) interaction with other medicinal products and other forms of interaction, (
ix)amounts to be administered and administration route, (
x)(
xi)overdose (symptoms, emergency procedures, antidotes), if necessary, withdrawal periods for the various foodstuffs, including those for which the withdrawal period is zero;

(5)pharmacological properties: (

i)pharmacodynamic properties, (
ii)pharmacokinetic particulars;

(6)pharmaceutical particulars: (

i)list of excipients, (
ii)major incompatibilities, (iii) shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time, (
iv)special precautions for storage, (
v)nature and composition of immediate packaging, (
vi)special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate;

(7)marketing authorisation holder; 25 Summary of product characteristics. Substituted by: L.N. 82 of 2006. 26 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS

(8)marketing authorisation number(s);

(9)date of the first authorisation or date of renewal of the authorisation;

(10)date of revision of the text. For authorisation under regulation 13, those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosage forms which were still covered by patent law at the time when a generic medicine was marketed need not be included. Necessary arrangements for documents to be drafted by experts. Substituted by: L.N. 82 of 2006. 15.

(1)Applicants shall ensure that the detailed and critical summaries referred to in the second paragraph of regulation 12

(3)are drafted and signed by persons with the requisite technical or professional qualifications, set out in a brief curriculum vitae, before being submitted to the Veterinary Services.

(2)Persons with the technical or professional qualifications referred to in subregulation

(1)shall justify any use made of the scientific literature referred to in regulation 13A

(1)in accordance with the conditions set out in the Schedule.

(3)A brief curriculum vitae of the persons referred to in subregulation

(1)shall be appended to the detailed critical summaries. CHAPTER 2 Particular provisions applicable to homeopathic veterinary medicinal products Registration or authorisation of homeopathic veterinary medicinal products. Substituted by: LN. 82 of 2006. 16.

(1)The Veterinary Services shall ensure that homeopathic veterinary medicinal products manufactured and placed on the market within the European Union are registered or authorised in accordance with regulations 17, 18 and 19, except where such veterinary medicinal products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In the case of homeopathic medicinal products registered in accordance with regulation 17, regulation 32 and regulation 33

(1)to

(3)shall apply.

(2)The Veterinary Services shall establish a simplified registration procedure for the homeopathic veterinary medicinal products referred to in regulation 17.

(3)By way of derogation from regulation 10, homeopathic veterinary medicinal products may be administered to non-food producing animals under the responsibility of a veterinary surgeon.

(4)By way of derogation from regulation 11

(1)and

(2), Malta s h a l l p e r m i t t h e a d m i n i st r a t i o n o f h o m e o p at h i c v e t e r i n a r y medicinal products intended for food-producing species the active constituents of which appear in Annex II to European Regulation (EEC) No 2377/90 under the responsibility of a veterinary surgeon. The Veterinary Services shall take appropriate measures to control the use of veterinary homeopathic medicinal products registered or authorised in another Member State in accordance with these regulations for use in the same species. [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS 17.

(1)Without prejudice to the provisions of European Regulation (EEC) No 2377/90 on the establishment of maximum residue limits of pharmacologically active substances intended for food-producing animals, only homeopathic veterinary medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure: 27 Homeopathic veterinary medicinal products which may be authorised. Amended by: L.N. 82 of 2006. (

a)they are administered by a route described in the European Pharmacopoeia or, in the absence thereof, by the Pharmacopoeias currently used officially in Malta; (
b)no specific therapeutic indication appears on the labelling of the veterinary medicinal product or in any information relating thereto; (
c)there is a sufficient degree of dilution to guarantee the safety of the medicinal product. In particular, the medicinal product shall not contain more than one part per 10 000 of the mother tincture.

(2)The criteria and rules of procedure provided for in Chapter 3, with the exception of regulation 25, shall apply by analogy to the special, simplified r egistration proce dure for homeopathic veterinary medicinal products referred to in subregulation

(1), with the exception of the proof of therapeutic effect. 18. A special, simplified application for registration may cover a series of medicinal products derived from the same homeopathic stock or stocks. The following documents shall be included with t h e a p p l i c a t i o n i n o r d e r t o d e m o n s t r a t e , i n p a r t i c u l a r, t h e pharmaceutical quality and the batch-to-batch homogeneity of the products concerned: (

a)scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered, (
b)dossier describing how any homeopathic stock has been obtained and is controlled, and justifying its homeopathic nature, on the basis of an adequate bibliography; in the case of homeopathic veterinary medicinal products containing biological substances, a description of the measures taken to ensure the absence of pathogens, (
c)manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation, (
d)manufacturing authorisation products concerned, for the medicinal (
e)copies of any registrations or authorisations obtained for the same medicinal products in Member States, (
f)one or more mock-ups of the outer packaging and immediate packaging of the medicinal products to be registered, Simplified application for registration. Amended by: L.N. 82 of 2006. 28 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS (
g)data concerning the stability of the medicinal product, (
h)proposed withdrawal period together with all requisite justification. Other homeopathic veterinary medicinal products. Substituted by: L.N. 82 of 2006. Immunological homeopathic veterinary medicinal products. 19.

(1)Homeopathic veterinary medicinal products other than those referred to in regulation 17

(1)shall be authorized in accordance with regulations 12, 13A, 13B, 13C, 13D and 14.

(2)Malta may introduce or retain on its territory specific rules for the safety tests and pre-clinical and clinical trials of homeopathic veterinary medicinal products intended for pet species and non-food-producing exotic species other than those referred to i n r e g u l a t i o n 1 7

(1), i n a c c o r d a n c e w i t h t h e p r i n c i p l es a n d characteristics of homeopathy as practised in Malta. In this case, the Veterinary Services shall notify the European Commission of the specific rules in force.

This Chapter shall not apply to immunological homeopathic veterinary medicinal products. The provisions of Titles VI and VII shall apply to homeopathic veterinary medicinal products. CHAPTER 3 Procedure for marketing authorisation Procedure for authorisation to place a veterinary medicinal product on the market. Substituted by: L.N. 82 of
21.

(1)The Veterinary Services shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for a veterinary medicinal product is completed within a maximum of two hundred and ten days days after the submission of a valid application. Applications for marketing authorisations for the same veterinary medicinal product in two or more Member States, shall be submitted in accordance with regulations 31 to 43.

(2)Where Malta notes that another marketing authorisation application for the same medicinal product is being examined in another Member State, Malta shall decline to assess the application and shall advise the applicant that regulations 31 to 43 apply. Authorisation to forward the assessment report. Substituted by: L.N. 82 of 2006. 22. Where the Veterinary Services is informed, in accordance with regulation 12

(3)(n), that another Member State has authorised a veterinary medicinal product which is the subject of an application for authorisation in Malta, the Veterinary Services shall reject the application unless it was submitted in compliance with regulations 31 to

Examination of application found under regulations 12 and
Substituted by: L.N. 82 of
In order to examine the application submitted pursuant to regulations 12 to 13D, the Veterinary Services

(1)shall check that the documentation submitted in support of the application complies with regulations 12 to 13D and ascertain whether the conditions for the issue of the marketing authorisation have been fulfilled;

(2)may submit the medicinal product, its starting materials and if necessary intermediate products or VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 29 other constituent materials for testing by an Official Medicines Control Laboratory or a laboratory that has designated for that purpose by the Veterinary Services, in order to ensure that the testing methods employed by the manufacturer and described in the application documents, in accordance with regulation 12

(3)(i), are satisfactory;

(3)may similarly check, in particular through consultation of a national or European Union reference laboratory, that the analytical method used for detecting residues presented by the applicant for the purposes of regulation 12

(3)(j), second indent is satisfactory;

(4)may, where appropriate, require the applicant to provide further information as regards the items listed in regulations 12, 13A, 13B, 13C and 13D. Where the Veterinary Services take this course of action, the time-limits specified in regulation 21 shall be suspended until the further data required have been provided. Similarly, these time-limits shall be suspended for any period which the applicant may be given to provide oral or written explanations. 24. that - The Director shall take all appropriate measures to ensure (a) the Veterinary Services ascertains that the manufacturers and importers of veterinary medicinal products from third countries are able to manufacture them in compliance with the details supplied pursuant to regulation 12

(3)(d), and, or to carry out control tests in accordance with the methods described in the application documents under regulation 12

(3)(i); Duties to be taken up by the Veterinary Services. (

b)the Veterinary Services may authorise manufacturers and importers of veterinary medicinal products from third countries, where circumstances so justify, to have certain stages of manufacture and, or certain of the control tests referred to in paragraph (
a)carried out by third parties; in such cases, checks by the Veterinary Services shall also be carried out in the establishments concerned. 25.

(1)When granting a marketing authorisation, the Veterinary Services shall inform the holder of the summary of product characteristics that it has approved.

(2)The Veterinary Services shall take all necessary measures to ensure that information concerning the veterinary medicinal product, and in particular the labelling and package leaflet, is in conformity with the summary of product characteristics approved when the marketing authorisation was granted or subsequently.

(3)The Veterinary Services shall make the marketing authorisation publicly available without delay, together with the summary of product characteristics for each veterinary medicinal product that it has authorised. Summary of the product characteristics. Substituted by: L.N. 82 of 2006. 30 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS

(4)The Veterinary Services shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical, safety and residue tests and the pre-clinical and clinical trials of the veterinary medicinal product concerned. The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the veterinary medicinal product concerned. The Veterinary Services shall make the assessment report and its reasons for the opinion publicly available without delay, after deleting any information of a commercially confidential nature. Other particulars essential for safety or health protection. Amended by: L.N. 82 of 2006. 26.

(1)The marketing authorisation may require the holder to indicate on the immediate packaging and, or the outer wrapping and the package leaflet, w here the latter is r equired, other particulars essential for safety or health protection, including any special precautions relating to use and any other warnings resulting f r o m t h e c l i n i c a l a n d p h a r m a c ol o g i c a l t r i a l s p r e s c r i b ed i n regulation 12

(3)(j) and in regulations 13 to 13D or from experience gained during the use of the veterinary medicinal product once it has been marketed.

(2)In exceptional circumstances, and following consultation with the applicant, the authorization may be granted subject to a requirement for the applicant to introduce specific procedures, in particular concerning the safety of the veterinary medicinal product, notification to the competent authorities of any incident relating to its use, and action to be taken. Such authorisations may be granted only for objective, verifiable reasons. Continuation of the authorization shall be linked to the annual reassessment of such conditions. Holder to take account of scientific and technical progress. Amended by: L.N. 82 of 2006. 27.

(1)After a marketing authorisation has been issued, the holder must, in respect of the manufacturing methods and control methods provided for in regulation 12

(3)(d) and (i), take account of scientific and technical progress and introduce any changes that may be required to enable that veterinary medicinal product to be manufactured and checked by means of gen er al ly accepted scientific methods. These changes shall be subject to the approval of the Veterinary Services.

(2)The Veterinary Services may require the applicant or the marketing authorisation holder to provide sufficient quantities of the substances to enable controls to be made on the identification of the presence of residues of the veterinary medicinal products in question. At the Veterinary Services’ request, the marketing authorisation holder shall provide his technical expertise to facilitate the implementation of the analytical method for detecting residues of the veterinary medicinal products in the national reference laboratory designated under European Union Council Directive 96/23/EC on measures to monitor certain substances and VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 31 residues thereof in live animals and animal products.

(3)The authorisation holder shall immediately supply the Veterinary Services with any new information that might entail the amendment of the particulars or documents referred to in regulations 12

(3), 13, 13A, 13B and 14 or in the Schedule. In particular, he shall immediately inform the Veterinary Services of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is placed on the market and of any other new information which might influence the assessment of the benefits and risks of the veterinary medicinal product concerned. In order to permit continuous assessment of the risk-benefit balance, the Veterinary Services may at any time ask the marketing authorisation holder to forward data demonstrating that the riskbenefit balance remains favourable.

(4)(Deleted by L.N. 82 of 2006).

(5)The marketing authorisation holder shall immediately inform the Veterinary Services, with a view to authorisation, of any a l t e r a t i o n w hi c h h e p r o p o s e s to m a k e t o t h e p a r t i c ul a r s o r documents referred to in regulations 12 to 13D. 27A. After a marketing authorisation has been granted, the holder of the authorisation shall inform the Veterinary Services of the date of the actual placing on the market of the veterinary medicinal product in Malta, taking into account the various presentations authorised. Holder to inform the Veterinary Services. Added by: L.N. 82 of 2006. The holder shall also notify the Veterinary Services if the product ceases to be placed on the market o f M alta, either temporarily or permanently. Such notification shall, otherwise than in exceptional circumstances, be made no less than two months before the interruption in the placing on the market of the product. Upon request by the Veterinary Services, particularly in the context of pharmacovigilance, the marketing authorization holder shall provide the Veterinary Services with all data relating to the volume of sales of the veterinary medicinal product, and any data in his possession relating to the volume of prescriptions. 28.

(1)Without prejudice to subregulations

(4)and

(5), a marketing authorisation shall be valid for five years.

(2)The authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance. To this end, the marketing authorisation holder shall submit a consolidated list of all documents submitted in respect of quality, safety and efficacy, including all variations introduced since the marketing authorization was granted, at least six months before the marketing authorisation ceases to be valid in accordance with subregulatioon

(1). The Veterinary Services may require the applicant to submit the listed documents at any time.

(3)Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the Veterinary Services decides, on Validity and renewal of authorisation. Substituted by: L.N. 82 of 2006. 32 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal in accordance with subregulation

(2).

(4)Any authorisation that is not followed within three years of its granting by the actual placing on the market of the authorised veterinary medicinal product in Malta, shall cease to be valid.

(5)When an authorised veterinary medicinal product previously placed on the market in Malta is no longer actually present on Malta for a period of three consecutive years, the authorisation granted for that veterinary medicinal product shall cease to be valid.

(6)The Veterinary Services may, in exceptional circumstances, and on human or animal health grounds, grant exemptions from subregulations

(4)and

(5). Such exemptions shall be duly justified. General legal liability of manufacturer.

The granting of authorisation shall not diminish the general legal liability of the manufacturer and, where appropriate, of the authorisation holder. Instances when the marketing authorisation shall be withheld. Substituted by: L.N. 82 of
Amended by: L.N. 179 of
The marketing authorisation shall be refused if the file submitted to the Veterinary Services does not comply with regulations 12 to 13D and regulation
The authorisation shall also be refused if, after examination of the documents and particulars listed in regulations 12 and 13

(1), it is clear that (

a)the risk-benefit balance of the veterinary medicinal product is, under the authorised conditions of use, unfavourable; when the application concerns a veterinary medicinal product for zootechnical use, particular regard shall be had to the benefits for animal health and welfare and to consumer safety; or (
b)the product has no therapeutic effect or the applicant has not provided sufficient proof of such effect as regards the species of animal which is to be treated; or (
c)its qualitative or quantitative composition is not as stated; or (
d)the withdrawal period recommended by the applicant is not long enough to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer, or is insufficiently substantiated; or (
e)the labelling or the package leaflet proposed by the applicant does not comply with these regulations; or (
f)the veterinary medicinal product is offered for sale for a use prohibited under other European Union provisions. However, when a European Union legislative framework is in the course of being adopted, the Veterinary Services may refuse authorisation for a veterinary medicinal product where such action is necessary for the protection of public health, consumer or animal VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 33 health. The applicant or marketing authorisation holder shall be responsible for the accuracy of documents and data submitted. CHAPTER 4 Mutual recognition procedure and decentralized procedure Substituted by: L.N. 82 of 2006. 31.

(1)With a view to the granting of a marketing authorization for a veterinary medicinal product in more than one Member State, the applicant shall submit an application based on an identical dossier in those Member States. The dossier shall contain all the administrative information and scientific and technical documentation described in regulations 12 to

The docu ments subm itted shall i nclu de a list of Mem ber States concerned by the application. Procedure before submitting an application for mutual recognition of marketing practices. Substituted by: L.N. 82 of
The applicant shall request one Member State to act as reference Member State and to prepare an assessment report in respect of the veterinary medicinal product in accordance with subregulation

(2)or

(3). Where appropriate, the assessment report shall contain an evaluation for the purposes of regulation 13

(5)or regulation 13A

(3).

(2)If the veterinary medicinal product has already received a marketing authorisation at the time of application, the concerned Member States shall recognize the marketing authorisation granted by t he reference Mem ber State. To thi s end, t he m ark et ing authorization holder shall request the reference Member State either to prepare an assessment report in respect of the veterinary m e d i c i n a l p r o d u c t o r, i f n e c e s s a r y, t o u p d a t e a n y e x i s t i n g assessment report. The reference Member State shall prepare or update the assessment report within ninety days of receipt of a valid application. The assessment report together with the approved summary of product characteristics, labelling and package leaflet shall be forwarded to the concerned Member States and the applicant.

(3)If the veterinary medicinal product has not received authorisation by the time of application, the applicant shall request the reference Member State to prepare a draft assessment report and drafts of the summary of product characteristics, labelling and package leaflet. The reference Member State shall prepare these drafts within one hundred and twenty days of the receipt of a valid application and shall send them to the concerned Member States and the applicant.

(4)Within ninety days after receipt of the documents referred to in subregulations

(2)and

(3), the Member States concerned shall approve the assessment report, the summary of product characteristics, the labelling and the package leaflet and inform the reference Member State accordingly. The reference Member State shall record the agreement of all parties, close the procedure and inform the applicant accordingly.

(5)Each Member State in which an application following 34 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS paragraph 1 has been submitted shall adopt a decision in conformity with the approved assessment report, summary of product characteristics, labelling and package leaflet within thirty days after acknowledgement of the agreement. Procedure by the Veterinary Services upon grounds for supposing that the marketing authorisation of the veterinary medicinal product concerned may present a risk to human health or animal health. Substituted by: L.N. 82 of 2006. 32.

(1)If Malta cannot, within the period allowed in regulation 31

(4), agree with the assessment report, summary of product characteristics, labelling and package leaflet on grounds of a potential serious risk to human or animal health or to the environment, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States concerned and the applicant. The points of disagreement shall be referred without delay to the coordination group. If a Member State to which an application has been submitted invokes the reasons referred to in regulation 64

(1), it shall no longer be regarded as a Member State concerned by this Chapter.

(2)Within the co-ordination group, all Member States referred to in subregulation

(1)shall use their best endeavours to reach agreement on the action to be taken. They shall provide the applicant with the opportunity to make his point of view known orally or in writing. If, within sixty days of the communication of the reasons for disagreement to the coordination group the Member States reach an agreement, the reference Member State shall record the agreement, close the procedure and inform the applicant accordingly. Regulation 31

(5)shall apply in such cases.

(3)If within the period of sixty days the Member States fail to reach an agreement, the Agency shall be immediately informed with a view to application of the procedure laid down in Articles 36, 37 and 38 of European Union Council Directive 2004/28/EC. The Agency shall be provided with a detailed description of the matters on which agreement could not be reached and the reasons for the disagreement. The applicant shall be provided with a copy of such information.

(4)As soon as the applicant has been informed that the matter has been referred to the Agency, he shall forthwith forward to the Agency a copy of the information and documents referred to in the first subparagraph of regulation 31

(1).

(5)In the case referred to in subregulation

(3), the Member States that have approved the assessment report, summary of product characteristics, labelling and package leaflet of the reference Member State may, on request by the applicant, grant a marketing authorisation for the veterinary medicinal product without waiting for the outcome of the procedure laid down in Article 36 of European Union Council Directive 2004/28/EC. In that case, the authorisation granted shall be without prejudice to the outcome of that procedure. VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 35

If two or more applications submitted in accordance with regulations 12 to 14 have been made for marketing authorisation for a particular veterinary medicinal product and Member States have adopted divergent decisions concerning the authorisation of that veterinary medicinal product, or suspension or revocation of authorisation, a Member State, or the European Commission, or the marketing-autho risation holder m ay refer the matter to the Committee for Medicinal Products for Veterinary Use, hereinafter referred to as "the Committee", for the application of the procedure laid down in Articles 36, 37 and 38 of European Union Council Directive 2004/28/EC. Several applications for marketing authorisation for a particular veterinary medicinal product. Substituted by: L.N. 82 of
Malta or the European Commission or the applicant or marketing authorisation holder shall, in specific cases where the interests of the European Community are involved, refer the matter to the Committee for the application of the procedure laid down in Articles 36, 37 and 38 of European Union Council Directive 2004/ 28/EC before a decision is reached on a request for a marketing authorization or on the suspension or withdrawal of an authorisation, or on any other variations to the terms of a marketing authorisation which appear necessary, so as to take account in particular of the information collected in accordance with Title VII. Situation when the matter has to be referred to the Committee before reaching a decision. Substituted by: L.N. 82 of
Malta or the European Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the applicant or the marketing authorisation holder. Malta and the applicant or the marketing authorisation holder shall forward to the Committee all available information relating to the matter in question. 35.

(1)Where the Director considers that the variation of the terms of a marketing authorisation which has been granted in accordance with the provisions of this Chapter or its suspension or withdrawal is necessary for the protection of human or animal health or the environment, it shall forthwith refer the matter to the Agency for the application of the procedure laid down in articles 36, 37 and 38 of European Union Council Directive 2001/82. Necessity for variation of the terms of a marketing authorisation.

(2)Without prejudice to the provisions of regulation 34

(1), in exceptional cases, where urgent action is essential to protect human or animal health or the environment, until a definitive decision is adopted, the Director may suspend the marketing and the use of the veterinary medicinal product concerned on its territory. It shall inform the European Commission and the other Member States no later than the following working day of the reasons for its action.

Articles 39 and 40 of European Union Council Directive 2001/82/EC shall apply by analogy to veterinary medicinal products authorised by Member States following an opinion of the Committee given in accordance with previous regulations. Application of articles 39 and 40 of European Union Council Directive 2001/82/EC. 36 [ S.L.437.47 Non-application to homeopathic veterinary medicinal products. Substituted by: L.N. 82 of
VETERINARY MEDICINAL PRODUCTS
Regulations 32

(3),

(4)and

(5)and 33 to 34 shall not apply to the homeopathic veterinary medicinal products referred to in regulation 17. Regulations 31 to 34 shall not apply to the homeopathic veterinary medicinal products referred to in regulation 19

(2). TITLE IV MANUFACTURE AND IMPORTS Manufacturing and importation regulations. Amended by: L.N. 82 of 2006. Substituted by: L.N. 179 of 2021. 38.

(1)(

a)(
b)(
c)(
d)(
e)(
f)(
g)The provisions of this Title shall not apply to: magistral formula; officinal formula; veterinary medicinal products intended for research and development trials; intermediate products intended for further processing by an authorised manufacturer; any radionuclides in the form of sealed sources; whole blood, plasma or blood cells of animal origin, except for plasma which is prepared by a method involving an industrial process; veterinary medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of a veterinary surgeon and for use by an individual animal under his direct personal responsibility.

(2)The provisions of these regulations shall apply also to the manufacture and assembly of homeopathic veterinary medicinal products, veterinary medicinal products derived from animal blood or plasma, radiopharmaceuticals, immunological veterinary medicinal products and herbal veterinary medicinal products.. Manufacturing authorisation for veterinary medicinal products and active substances. Substituted by: L.N. 179 of 2021. 39.

(1)(a)No veterinary medicinal product, biological active substance, or active substance to be used directly as an investigational veterinary medicinal product, may be manufactured in Malta unless there is, in respect of such product or substance, a Manufacturing Authorisation. This Manufacturing Authorisation shall also be required for the processes of sterilisation of active substances. (

b)The Manufacturing Authorisation shall also be required for the manufacture of veterinary medicinal products intended for export. 2. (a)The Manufacturing Authorisation, which shall remain in force for a period to be determined by the Veterinary Services, shall be required for both total and partial manufacture, and for the various processes of dividing up, packaging or presentation. (
b)A Manufacturing Authorisation shall not be required for preparation, dividing up, changes in packaging or presentation where such processes are carried out solely for retail supply by pharmacists in veterinary VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 37 pharmacies, or by other persons legally authorised to carry out such processes.

(3)The authorisation referred to in sub-regulation

(1)shall also be required for imports from third countries into the territory of Malta; The Director shall take all appropriate measures to ensure that veterinary medicinal products brought into the territory from a third country and destined for Member States are accompanied by a copy of the authorisation referred to in sub-regulation

(1).

(4)Any application for the grant of a licence to manufacture, assemble or modify a veterinary medicinal product shall be made to the Veterinary Services and shall contain such information, d oc u m e n ts , sa m p l e s a nd o t h e r m a t e r i a l a s p r o v i d e d b y t h e provisions of these regulations.

(5)A Manufacturing Authorisation shall include a licence to distribute by wholesale the veterinary medicinal products in respect of which the Manufacturing Authorisation has been issued.

(6)The Veterinary Services shall forward to the Agency a copy of the Authorisation referred to in sub-regulation

(1).

(7)The Veterinary Services shall enter the information relating to the Authorisation referred to in sub-regulation

(1)in the European Union database referred to in regulation 72

(6). 40. The Veterinary Services, shall only grant or renew an Authorisation, if the applicant: (

a)specifies the veterinary medicinal products and pharmaceutical forms which are to be manufactured or imported and the place where they are to be manufactured and, or controlled; Renewal of a manufacturing and import Authorisation. Substituted by: L.N. 179 of 2021. (
b)has at his disposal, for the manufacture or import of veterinary medicinal products, suitable and sufficient premises, technical equipment and control facilities complying with requirements set by the Veterinary Services; (
c)has at his disposal the services of at least one qualified person within the meaning of regulation 46; and (
d)provides all necessary documentation in support of his application. 41.

(1)(a)The Veterinary Services shall issue the Authorisation after verifying the contents of the application but in any case not later than ninety

(90)days from receipt of the application. (

b)(
c)This time period shall be suspended when the Veterinary Services requests additional information from the applicant. The Veterinary Services shall, before determining an application, inspect the premises indicated in the Time taken for the procedure to grant the authorisation. Substituted by: L.N. 179 of 2021. 38 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS (
d)application and shall not issue an Authorisation until it is satisfied that such premises conform with the requirements established by the provisions of these regulations; The Veterinary Services may grant a conditional licence subject to the carrying out of certain obligations imposed on the applicant.

(2)The Authorisation shall apply only to the premises, veterinary medicinal products and pharmaceutical forms specified in the application.

(3)Where the Veterinary Services considers that circumstances may exist which would render necessary the consideration of whether the Authorisation should be varied, suspended or revoked, the Veterinary Services may serve on the holder of a manufacturer's Authorisation a notice requiring him, within such time as may be specified in the notice, to furnish it with any information specified in the notice. Variation of a manufacturing and import Authorisation. Substituted by: L.N. 179 of 2021. 42.

(1)When the holder of the Authorisation requests a change in the particulars specified in regulation 4(a) and 4(b), he shall apply in writing to the Veterinary Services. The process of verification of such information shall not exceed thirty

(30)days. However, in exceptional cases, this period of time may be extended to ninety

(90)days.

(2)The veterinary services may upon such an application made by the holder of Authorisation in request thereof, vary the condition of the licence if it is satisfied that such variation will not adversely a ffec t st and ard o f g oo d p ra ct ice i n manufac ture as m a y be prescribed.

(3)Where the Veterinary Services considers that circumstances may exist which would render necessary the consideration of whether the Authorisation should be varied, suspended or revoked, the Veterinary Services may serve on the holder of a manufacturing Authorisation a notice requiring him, within such time as may be specified in the notice, to furnish it with any information specified in the notice. Suspension of a manufacturing and import Authorisation. Substituted by: L.N. 179 of 2021. 43.

(1)The Veterinary Services may suspend a manufacturing Authorisation for such period as it may determine, or may refuse, revoke, or vary the provisions of, any such Authorisation.

(2)The powers vested in sub-regulation

(1)shall only be exercisable in any of the following circumstances, where: (

a)the matters stated in the application on which the Authorisation was granted were false or incomplete in an essential manner; (
b)a material change of circumstances has occurred in relation to any of those matters; VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 (
c)any of the conditions of the Authorisation has been contravened; (
d)the requirements in relation to the licences as established by these regulations have not been complied with; (
e)the processes of manufacture or assembly of a veterinary medicinal product are carried out in a manner that is not in compliance with the provisions of the marketing authorisation of that veterinary medicinal product; (
f)the conditions for good manufacturing practice are not being complied with; (
g)there is sale and processing of active substance and veterinary medicinal products under unsanitary conditions or leading to adulteration; and (
h)in any other circumstance as is established under these regulations.

(3)The Veterinary Services shall carry out regular inspections to ensure that the requirements established by these regulations in relation to the m anufacture, assem bly o r m odifi cati on of a veterinary medicinal product or active substance are complied with.

(4)With respect to the manufacture of veterinary medicinal products or active substance the Veterinary Services or any authorised person carrying out an inspection shall: (

a)inspect the manufacturing establishment and any other location and at any reasonable time the Director may deem necessary; (
b)examine any relevant documents; (
c)take any samples the Director may deem necessary and if necessary submit them to designated laboratories for testing; (
d)open or/and examine or/and seize any article believed to be in violation of these regulations or for obtaining evidence; (
e)draw up a report of the findings and communicate the contents of such report to the Manufacturing Authorisation holder or the applicant for a Manufacturing Authorisation and to the qualified person in relation to such inspection; (
f)carry out any other activity the Director may deem appropriate for the proper execution of his duties and responsibilities as provided by these regulations; (
g)produce, upon request by the inspected part, the designated document containing information on the legal basis and scope of the inspection and the identification of the inspector/s; 39 40 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS (
h)at the time of the inspection draw up a list of deficiencies that may have been identified and shall sign this list, and such list shall be countersigned by the holder of the Authorisation or his legal representative; (
i)shall draw up a report of the inspection within thirty

(30)working days of the inspection and shall forward a copy of such report to the holder of the Authorisation.

(5)Except in urgent cases an inspection shall be carried out in the presence of a qualified person or his representative.

(6)Subject to the provisions of these regulations, every licence shall, unless previously renewed or revoked, continue to be valid until such time as it is r enewed by the Veterinary S ervices following an inspection.

(7)The Veterinary Services shall establish the period of validity of any licence.

(8)Following the inspection mentioned in sub-regulation

(1), the Veterinary Services: (

a)may renew the licence, with or without modifications, for such a further period as specified; or (
b)if, having regard to the provisions of these regulations, it considers it necessary or expedient to do so, may refuse to renew the licence. Obligations of the holder of manufacturing authorisation and manufacturer of active substance. Amended by: L.N. 82 of 2006. Substituted by: L.N. 179 of 2021. 44.

(1)The holder of the Authorisation or the manufacturer of active substance shall: (

a)comply with the EU principles and guidelines of good manufacturing practice and any annexes thereof for veterinary medicinal products and use only active substances which have been manufactured in accordance with the EU guidelines on good manufacturing practice for active substances and distributed in accordance with good distribution practices for active substances. To this end, the holder of the manufacturing authorisation shall verify compliance by the manufacturer and distributors of active substances with good manufacturing practice and good distribution practices by conducting audits at the manufacturing and distribution sites of the manufacturer and distributors of active substances. The holder of the manufacturing authorisation shall verify such compliance either by himself or, without prejudice to his responsibility as provided for in these regulations and in the Act, through an entity acting on his behalf under a contract; (
b)inform the competent authority and the marketing authorisation holder immediately if he obtains VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 information that veterinary medicinal products which come under the scope of his manufacturing authorisation or the active substance are, or are suspected of being, falsified irrespective of whether those veterinary medicinal products were distributed within the legal supply chain or by illegal means, including illegal sale at a distance by means of information society services; (
c)verify that the manufacturers, importers or distributors from whom he obtains active substances are registered with the competent authority of the Member State in which they are established; (
d)verify the authenticity and quality of the active substances and the excipients. (
e)have at his disposal the services of staff complying with the legal requirements set by the Veterinary Services as regards both manufacture and controls (
f)dispose of the veterinary medicinal products only in accordance with the legislation of the territory of Malta; (
g)give prior notice to the Veterinary Services of any changes which he may wish to make to any of the particulars supplied pursuant to regulation 40 or other significant changes or of conditions which may affect the quality, safety or efficacy of the veterinary medicinal product. The Veterinary Services shall, in any event, be immediately informed if the qualified person referred to in regulation 46

(1)is replaced; (h) enable the qualified person referred to in regulation 46

(1)to carry out his duties, particularly by placing at his disposal all the necessary facilities; (

i)keep detailed records of all veterinary medicinal products supplied by him, including samples, in accordance with the laws of the countries of destination: (
i)date; (
ii)name of the veterinary medicinal product; (iii) quantity supplied ; (
iv)name and address of the recipient; (
v)batch number; These records shall be available for inspection by the Veterinary Services for a period of at least three

(3)years. (

j)the following information at least shall be recorded in 41 42 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS respect of each transaction, whether or not it is made for payment; (
k)record all suspected serious adverse reactions and human adverse reactions relating to the use of veterinary medicinal products that are brought to his attention and report them promptly to the Veterinary Services in no later than fifteen days following receipt of the information; (
l)implement a system for recording and reviewing complaints together with an effective system for recalling promptly and at any time the veterinary medicinal products or the active substance in the distribution network; (
m)record and investigate any complaint concerning quality defects; (
n)other responsibilities as may be established by the Veterinary Services from time to time;

(2)For the purposes of this regulation, manufacture of active substances used as starting materials shall include both total and partial manufacture or import of an active substance used as a starting material as defined in the Schedule Part 2. Section C of these regulations, and the various processes of dividing up, packaging or presentation prior to its incorporation into a veterinary medicinal product, including repackaging or re-labelling, such as are carried out by a distributor of starting materials.

(3)Manufacturing Authorisation holders shall be regarded as producers and therefore held liable for damages in the cases and under the conditions set forth in the Consumer Affairs Act. Cap. 378.

(4)It shall be the duty of the importer to ensure that: (

a)in the case of veterinary medicinal products and investigational veterinary medicinal products imported from third countries, these have been manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down in the Good Manufacturing Practice for Veterinary Medicinal Products Rules; S.L. 437. 108. (
b)in the case of veterinary medicinal products, such products have been manufactured by manufacturers duly authorised for the purpose; and (
c)in the case of investigational veterinary medicinal products, such products have been manufactured by a manufacturer notified to the competent authorities and accepted by them for that purpose. Starting materials. Added by: L.N. 82 of 2006. 44A. For the purposes of these regulations, manufacturing active substances for use as starting materials shall include the com plet e or part ial m anufacture or the im po rt o f an active substance used as a starting material, as defined in Part 2, Section C VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 43 of t h e S c hed ul e, an d th e var i ou s pr oc esses of di vi d in g up , packaging or presentation prior to its incorporation in a veterinary medicinal product, including repackaging or re-labelling, such as carried out by a starting material distributor. 45. The Veterinary Services may require from the applicant further information concerning both the particulars supplied pursuant to regulation 40 and the qualified person referred to in regulation 46

(1). Where the Veterinary Services exercise this right, application of the time limits referred to in regulations 41 and 42

(1)shall be suspended until the additional data required have been supplied. Additional information pursuant to the application of a manufacturing and import Authorisation. Substituted by: L.N. 179 of 2021. 46.

(1)The holder of the Authorisation shall have permanently and continuously at his disposal the services of at least one qualified person, in accordance with the conditions laid down in regulation 47, responsible in particular for carrying out the duties specified in regulation 49: Qualified person. Amended by: L.N. 82 of 2006; Substituted by: L.N. 179 of 2021. Provided that when more than one qualified person is nominated, the application will clearly delineate the specific responsibilities of each person: Provided further that the qualified persons may nominate another person similarly qualified to act as his representative.

(2)When the qualified person has nominated a representative as aforesaid he shall immediately inform the Veterinary Services of such nomination.

(3)If the manufacturing Authorisation holder personally has the qualifications laid down in regulation 47, then he may himself assume the responsibility of a qualified person. 47.

(1)For a person to be designated as qualified person, he must possess the following qualifications: (

a)a diploma; (
b)certificate or other evidence of formal qualifications awarded on completion of a university course of study; or (
c)a course recognised as equivalent by the territory of Malta, extending over a period of at least four

(4)years of theoretical and practical study in one of the following scientific disciplines - pharmacy, medicine, veterinary science, chemistry, pharmaceutical chemistry and technology, biology.

(2)However, the minimum duration of the university course may be three and a half (3.5) years where the course is followed by a period of theoretical and practical training of at least one

(1)year and includes a training period of at least six

(6)months in a pharmacy open to the public, corroborated by an examination at university level.

(3)The course shall include theoretical and practical tuition bearing upon at least the following basic subjects: Qualifications of the qualified person. Amended by: L.N. 82 of 2006. Substituted by: L.N. 179 of 2021. 44 [ S.L.437.47 VETERINARY MEDICINAL PRODUCTS (

a)experimental physics; (
b)general and inorganic chemistry; (
c)organic chemistry; (
d)analytical chemistry; (
e)pharmaceutical chemistry, medicinal products; (
f)including analysis of general and applied biochemistry (medical); (
g)physiology; (
h)microbiology; (
i)pharmacology, (
j)pharmaceutical technology; (
k)toxicology; (
l)pharmacognosy (study of the composition and effects of the active principles of natural substances of plant and animal origin).

(4)Tuition in these subjects should be so balanced as to enable the person concerned to fulfil the obligations specified in regulation 49.

(5)Where certain diplomas, certificates or other evidence of formal qualifications mentioned in this sub-regulation do not fulfil the criteria laid down above, the Veterinary Services shall ensure that the person concerned provides evidence that he has, in the subjects involved, the knowledge required for the manufacture and control of veterinary medicinal products.

(6)The qualified person shall have acquired practical experience over at least two

(2)years, in one or more undertakings which are authorised manufacturers, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of veterinary medicinal products.

(7)The duration of practical experience may be reduced by one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six

(6)years. Qualified persons in current employment. Amended by: L.N. 82 of 2006. Substituted by: L.N. 179 of 2021. 48.

(1)A person engaging, in Malta, in the activities of the person referred to in regulation 46

(1)on the date on which these regulations become applicable, without complying with the provisions of regulation 47, shall be eligible to continue to engage in those activities within the EU.

(2)The holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course or a course recognised as equivalent by the territory of Malta in a scientific discipline allowing him to engage in the activities of the person referred to in regulation 46

(1)in accordance with the laws of the territory of Malta, may, if he began his course prior to the date on which these regulations became applicable, be considered VETERINARY MEDICINAL PRODUCTS [ S.L.437.47 45 as qualified to carry out in the territory of Malta the duties of the person referred to in regulation 46

(1), provided that he has previously engaged in the following activities for at least two

(2)years before the date on which these regulations became applicable in one or more undertakings with a manufacturing authorisation, production supervision and, or qualitative and quantitative analysis of active substances, and the necessary testing and checking under the direct authority of a person as referred to in regulation 46

(1)to ensure the quality of veterinary medicinal products. If the person concerned has acquired the practical experience referred to in sub-regulation

(1)before the date on which these regulations became applicable, a further one year ’s practical experience in accordance with the conditions referred to in subregulation

(1)shall be completed by him immediately before he engages in such activities. 49.

(1)The qualified person, without prejudice to his r e l a t i o n s h i p wi t h t he h o ld e r of t h e A u t h or is a t i o n , sh a l l b e responsible to ensure that: (

a)each batch of veterinary medicinal products manufactured in Malta has been manufactured and checked in terms of the laws in force and is in accordance with the requirements of the marketing authorisation; (
b)in the case of veterinary med

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AI explanation based on the official legal text. Indicative, not a substitute for legal advice.

L.S. 437.47(R) Regolamenti dwar Prodotti Mediċinali Veterinarji Imħassrin bl-Avviż Legali 335 tal-2024