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L.S. 437.115 Regolamenti dwar Prodotti Mediċinali Veterinarji

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VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115 SUBSIDIARY LEGISLATION 437.115 VETERINARY MEDICINAL PRODUCTS REGULATIONS 10th February, 2025 LEGAL NOTICE 335 of 2024. 1. (1) The title of these regulation

profit or non-profit, from a third country; "investigational veterinary medicinal product’" means a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way which is different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form;   S.L. 437.

  1. "licensed veterinary establishment" shall have the same meaning as that assigned to it in the Private Veterinary Establishments (Licensing) Regulations;  Cap.
  2. "medicinal products for human use" shall have the same meaning as that assigned to it in the Medicines Act; "Member State" means a State which is a member of the European Union; "narcotic drugs" means the substances present on the VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115 Yellow List established by the International Narcotics Control Board in accordance with the Protocol of 25 March 1972 amending the Single Convention on Narcotic Drugs, 1961; "pharmacist" means a person who is enlisted in the Register of Pharmacists kept by the Pharmacy Council in accordance with article 17 of the Health Care Professions Act;    Cap.
  3. "premises" means the premises used for, or in connection with, any premises authorised or licensed by the Director, as the case may be; "prescribing" means the act of preparing a veterinary prescription by a veterinary surgeon whether on paper or through electronic media; "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 the International Narcotics Control Board in accordance with the Convention on Psychotropic Substances of 1971, as amended; "Regulation (EU) 2019/6" means Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC; "responsible person" means the technically competent person referred to in Article 101 of Regulation (EU) 2019/6; "Single Convention" means the Single Convention on Narcotic Drugs adopted at New York on the 30th March 1961, as subsequently amended by the Protocol adopted in Geneva on the 25th March, 1972; "suitably learned person" means any person included in the Register of the Professions and Trades Supplementary to the Veterinary Profession provided for in the Act who may dispense veterinary medicinal products of category OTC under the supervision of a veterinary surgeon or pharmacist and dispense others of category GS without this supervision; "veterinary pharmacy" means any premises licensed in accordance with article 62 of the Act in which any veterinary medicinal product is kept, or from where it is sold, dispensed or supplied directly to the public by retail, but shall not include dispensing of treatments from veterinary establishments and   Cap.
  4. 3 4 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS dispensing during out calls by veterinary surgeons; "veterinary surgeon" means a person who has a warrant granted in accordance with article 43 of the Act; "wholesale distributor of veterinary medicinal products" means the holder of a valid wholesale distribution authorisation referred to in Article 99

(1)of Regulation (EU) 2019/6.
(2)Unless the context otherwise requires, words and phrases used in these regulations which are not herein defined shall have the same meaning assigned to them in the Act: Provided that words and phrases used in these regulations which are neither defined in these regulations nor in the Act shall have the same meaning assigned to them in Regulation (EU) 2019/
  1. Languages.
  2. The Director shall determine the language or languages of the summary of the product characteristics and the information on the labelling and on the package leaflet of veterinary medicinal products to be marketed in the territory of Malta and make this information public. Package leaflet.
  3. The package leaflet of a veterinary medicinal product may be made available on paper, electronically, or both of them. Exemptions from a marketing authorisation. 5.
(1)

Article 5

(6)of Regulation (EU) 2019/6, the applicant shall submit an application in the form provided for by the Director and shall pay the established fee: Provided that the veterinary medicinal product shall only be placed on the market when the authorisation is issued by the Director.
(2)The exemption stipulated under Article 5
(6)of Regulation (EU) 2019/6 shall only be granted at the discretion of the Director.
(3)The holder of an authorisation in accordance with this regulation shall notify the Director within fifteen
(15)days of becoming aware of any adverse reaction and shall keep records of such incidents: Provided that the records provided for in this regulation shall be kept by a holder of an authorisation in accordance with this regulation for five
(5)years and shall be made available to the Director upon his request. VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115
(4)The Director may publish a list of active substances that may be used in veterinary medicinal products authorised in accordance with this regulation. This list shall specify the species of non-food producing animals for which the active substances are approved. This list may also specify the manner in which the product containing the active substances are to be administered.
(5)The Director may reject an application or may suspend and, or revoke the authorisation granted in accordance with this regulation if any one
(1)or more of the following occur: (
  1. a)adverse reactions are reported and confirmed; (
  2. b)it is demonstrated, at any time after authorisation, that the risk-benefit is unfavourable; (
  3. c)the product contains active substances that are reclassified as narcotic or psychotropic drugs; (
  4. d)any one
(1)of the ingredients in the product is not included anymore in the list of active substances mentioned in sub-regulation
(4); and (e) it is reported and is verified by the Director that the product is not being used on animals as established in Article 5
(6)of Regulation (EU) 2019/6.
(6)The products authorised under this regulation shall be labelled with the following: (
  1. a)the name of the veterinary medicinal product; (
  2. b)the pharmaceutical form; (
  3. c)the name and strength of each active substance; (
  4. d)the route of administration; (
  5. e)the batch number; (
  6. f)the expiry date; (
  7. g)a statement to the effect of "For administration on non-food producing animals only. Veterinary medicinal product authorised in accordance with Article 5
(6)of Regulation (EU) 2019/6"; (
  1. h)the target species; 5 6 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS (
  2. i)storage instructions, if applicable; (
  3. j)therapeutic indications, if applicable; (
  4. k)contra-indications, if applicable; and (
  5. l)interaction with other medicines and other forms of interaction, if applicable.
(7)The authorisation granted in accordance with this regulation shall be valid for a period of five
(5)years. Authorisation for research and development purposes. 6.
(1)Veterinary medicinal products, investigational veterinary medicinal products and active substances shall not be used for research and development purposes unless the Director grants such authorisation to the applicant.
(2)The applicants requesting authorisation to use veterinary medicinal products, investigational veterinary medicinal products and, or active substances for research and development purposes shall submit an application in the form provided by the Director before the activity takes place and shall pay the relevant fee.
(3)Veterinary medicinal products authorised in accordance with this regulation may be exempt from the requirements established by Articles 5, 88 and 99 of Regulation (EU) 2019/6.
(4)Active substances authorised in accordance with this regulation may be exempted from the requirements established by Article 95 of Regulation (EU) 2019/6.
(5)The authorisation granted in accordance with this regulation shall be valid for a period of three
(3)years.
(6)An authorisation in accordance with this regulation shall be granted without prejudice to any authorisation, licence or permit that the applicant may need to obtain from another entity in order to engage in the research activity involving veterinary medicinal product, investigational veterinary medicinal products or active substances.
(7)The Director may establish, amend, add or remove any terms and conditions pertaining to the authorisation that he may deem fit in light of scientific advancements or new information that may arise, from time to time. VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115
(8)If applicable, the holder of the authorisation in accordance with this regulation shall administer the product to the test animal after obtaining prior authorisation from the relevant entity and only in accordance with the terms and conditions set out in the Animal Welfare Act and the Protection of Animals used for Scientific Purposes Regulations. 7       Cap. 439.  S.L. 439.20.
(9)Unless a withdrawal period is determined, test animals administered veterinary medicinal products, investigational veterinary medicinal products and active substances authorised in accordance with this regulation shall be excluded permanently from the food chain.
(10)The holder of an authorisation in accordance with this regulation shall notify the Director within fifteen
(15)days of becoming aware of any adverse reactions on the animal or on the person administering the products or substances in terms of this regulation: Provided that the records provided for in this regulation shall be kept by the holder of an authorisation in accordance with this regulation for a period of five
(5)years and shall be made available to the Director upon his request.
(11)The Director may carry out inspections on the premises and the activities being carried out on the premises by the holder of the authorisation. 7.
(1)Veterinary medicinal products may be exempted from the requirements provided for in Articles 5, 88 and 99 of Regulation (EU) 2019/6 when the products are acquired from a Member State or imported for personal use provided that all the following conditions are fulfilled: (
  1. a)the products shall not be sold or re-sold; (
  2. b)the products shall not be transferred to other third parties unless such transfer is notified to the Director; (
  3. c)the quantity of products obtained shall be proportional to the dosage regime of the condition it will be used for; (
  4. d)the quantity of products which is allowed entry in the territory of Malta shall cover the period indicated as the duration of treatment in the product’s specifications or on the veterinary prescription. However, products intended to be used Veterinary medicinal products obtained for personal use. 8 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS for recurrent or chronic conditions may be allowed entry in the territory of Malta several times a year, provided that cogent evidence that demonstrates the benefits obtained by the regular use of the products can be provided; (
  5. e)a veterinary prescription shall be provided for products classified as requiring such a prescription in the country from where they are obtained, or for similar veterinary medicinal products in the territory of Malta: Provided that the Director may still require the veterinary prescription when the products are classified as not requiring a veterinary prescription in the country from where they are obtained; (
  6. f)only products that do not contain animal byproducts which are derived from high-risk areas where certain diseases may be, or suspected to be, present or prevalent, shall be obtained; (
  7. g)only products that do not contain ingredients which are classified as illegal in territory of Malta and which do not have banned indications in the territory of Malta shall be obtained; (
  8. h)only appropriately labelled products which give clear indication of the nature of the ingredients thereof shall be obtained; (
  9. i)food producing animals administered with the veterinary medicinal products authorised in accordance with this regulation may only be consumed by the individual getting the veterinary medicinal products, or by other consenting persons of the same household. The appropriate withdrawal period shall apply, where applicable; (
  10. j)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 Director in a timely manner; and (
  11. k)the Director’s decision shall be without prejudice to any license or permit that the individual getting the veterinary medicinal products may need to obtain under other regulations or rules. VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115
(2)This regulation shall not be applicable to live or attenuated immunological veterinary medicinal products, 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 the Measures to monitor certain Substances and Residues thereof in Live Animals and Animal Products Rules and the substances listed in Table 2 of Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin.        S.L. 437.58.
(3)The Director may release, retain or destroy any veterinary medicinal products alone or in feed, active substances or other products intended to be administered to or on animals or given as feed or with feed or water if and when these products are intercepted at the various entry control points throughout the territory of Malta, or in any establishments under his control.
(4)Any expense incurred for the release, retention or destruction of veterinary medicinal products alone or in feed, active substances or other products intended to be administered to, or on animals or given as feed or with feed or water, shall be payable by the person getting the products as determined by the Director.
(5)Pursuant to sub-regulation
(3), the Director may keep a record of all instances of release, retention or destruction. These records shall be kept by the Director for a period of not less than fifteen
(15)years.
(6)The Director may issue a list with the requirements needed for obtaining veterinary medicinal products in accordance with this regulation through a notice in the Gazette: Provided that the provisions of this regulation shall also apply to veterinary medicinal products that are brought in the territory of Malta as a donation for use on animals kept in approved sanctuaries subject to the donations: Provided further that the Director shall be notified of such request with the name, quantity and nature of the products, the names and addresses of the donor, the recipient and the animal sanctuaries involved. 8.
(1)Before the placing on the market of any veterinary medicinal product as established by Article 116 of Regulation (EU) 2019/6, a person shall register every veterinary medicinal product with the Director in the manner provided by him and shall pay the relevant fee. Registration in accordance with Article 116 of Regulation (EU) 2019/6. 9 10 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS
(2)Before approving the registration, the Director may: (
  1. a)request the competent authority in the country of source to furnish a copy of the current marketing authorisation; (
  2. b)ensure that the entity applying for a registration in accordance with Article 116 of Regulation (EU) 2019/6 is a legally established company in the European Union or European Economic Area; (
  3. c)notify the marketing authorisation holder of his intention to grant a registration in accordance with Article 116 of Regulation (EU) 2019/6 when the applicant is not the same entity as the marketing authorisation holder in the country of source; (
  4. d)request the applicant to furnish a copy of the current marketing authorisation: Provided that when it is not possible for the applicant to provide a copy of the current marketing authorisation, he shall be required to provide alternative evidence that the product is being marketed in the country of source; (
  5. e)request from the applicant data on the impact of the product on the environment in the territory of Malta; (
  6. f)request the applicant to furnish a letter of access issued by the market authorisation holder granting him the use of the marketing authorisation

Article 116

of Regulation (EU) 2019/6: Provided that when it is not possible for the applicant to obtain a letter of access from the market authorisation holder, the applicant may be requested by the Director to provide evidence that due diligence has been exercised to ensure that the veterinary medicinal products were obtained from a duly authorised supplier of veterinary medicinal products in the country of source; and (g) ensure that the applicant has a system in place for the recording and investigation of adverse drug reactions and defects in a batch or veterinary medicinal product.

(3)After registration in accordance with this regulation, the registration holder shall ensure that: VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115 (
  1. a)the veterinary medicinal product is kept in line with the marketing authorisation issued in the country of source for as long as the registration remains valid; (
  2. b)the Director is notified of any variation to the terms of the marketing authorisation approved in the country of source that affects the summary of the products’ characteristics, the package leaflet, the packaging, the labelling and any change in administrative details that may have been made after the original registration; (
  3. c)any action relating to adverse drug reaction and, or a product or batch recall shall be implemented without delay; and (
  4. d)he is responsible for the requirements in paragraph (c), or appoints another person for such purpose.
(4)By way of derogation from Article 2
(1)and
(2)of the Regulation (EU) 2019/6, only Articles 57, 94, 117, 119, 123 and 134 of Regulation (EU) 2019/6 shall apply to veterinary medicinal products registered in accordance with Article 116 of Regulation (EU) 2019/6.
(5)The registration granted in accordance with this regulation shall be valid for a period of three
(3)years. 9.
(1)A veterinary medicinal product shall not be procured from another Member State or imported by veterinary surgeons before the Director grants the necessary authorisation in accordance with Articles 110
(2)and
(3), 112, 113 and, or 114 of Regulation (EU) 2019/6.
(2)Veterinary surgeons shall apply in the manner provided by the Director to obtain an authorisation for procuring a veterinary medicinal product from another Member State or for the importation of veterinary medicinal products in accordance with Articles 110
(2)and
(3), 112, 113 or 114 of Regulation (EU) 2019/6 and shall pay the relevant fee.
(3)The authorisation granted in accordance with this regulation shall be valid for a period of one
(1)year.
(4)Veterinary surgeons shall keep adequate records of the treatment given with the veterinary medicinal products authorised in accordance with this regulation for a period of not less than five
(5)years and shall be made readily available to the Director upon his request. Cascade use of veterinary medicinal products. 11 12 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS
(5)The records provided for in this regulation shall include the identification, including the target species, of the animal or group of animals, the date of supply, the dosage, the administration instructions and the withdrawal period assigned, if applicable.
(6)

this regulation, the activity undertaken by the veterinary surgeons shall be excluded from the provisions of Articles 88 and 99 of Regulation (EU) 2019/6. Registration of homeopathic veterinary medicinal products. 10.

(1)

Article 86

of Regulation (EU) 2019/6, a person shall submit a request in the manner indicated by the Director for each homeopathic veterinary medicinal product that he intends to register and place on the market and shall pay the relevant fee.

(2)The registration granted in accordance with this regulation shall be valid for a period of five
(5)years. Parallel trade. 11.
(1)

Article 102

of Regulation (EU) 2019/6, wholesale distributors shall submit a request in the manner indicated by the Director for the registration of each veterinary medicinal product intended for parallel trade and shall pay the relevant fee.

(2)The registration granted in accordance with this regulation shall be valid for a period of five
(5)years. Manufacturing of veterinary medicinal products and active substances. 12.
(1)

these regulations, the manufacture of active substances shall include both total and partial manufacture or importation of an active substance, and the various processes of dividing up, packaging or presentation prior to their incorporation into a veterinary medicinal product, including repackaging or re-labelling, as are carried out by a distributor.

(2)

Article 89

of Regulation (EU) 2019/6, the applicants shall submit an application in the manner provided by the Director to obtain the manufacturing authorisation referred to in Article 88

(1)of Regulation (EU) 2019/6 and shall pay the relevant fees.
(3)A manufacturing authorisation shall not be required for preparation, division, changes in packaging or presentation where these processes are carried out solely for retail directly to the public by pharmacists in veterinary pharmacies, or by other persons legally authorised to supply veterinary medicinal products to the public.
(4)The manufacturing authorisation shall only be granted by VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115 the Director when the requirements provided for in Article 89 of Regulation (EU) 2019/6 are satisfied.
(5)The Director may, upon a request by the holder of authorisation for a change in the manufacturing authorisation, vary the condition of the authorisation if he is satisfied that such change will not adversely affect the standard of good practice in manufacture as may be prescribed.
(6)

Article 133

of Regulation (EU) 2019/ 6 and when the Director considers that circumstances may exist which necessitate the consideration of whether the authorisation should be varied, suspended or revoked, the Director may serve on the holder of a manufacturing authorisation a notice requiring him, within such period as may be specified in such notice, to obtain any information specified in the notice.

(7)The Director may, at his own discretion, suspend, revoke or vary the conditions of a manufacturing authorisation if: (
  1. a)the information stated in the application on which the authorisation was granted was false or incomplete in an essential manner; (
  2. b)a material change of circumstances has occurred in relation to any of such information; (
  3. c)any condition of the authorisation has been contravened; (
  4. d)the requirements in relation to the authorisation as established by these regulations and Regulation (EU) 2019/6 have not been complied with; (
  5. 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; (
  6. f)the conditions for good manufacturing practice are not being complied with; (
  7. g)there exists the sale and processing of active substance and veterinary medicinal products under unsanitary conditions or leading to adulteration; and (
  8. h)there occurs any of the other circumstances 13 14 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS established under these regulations.
(8)The Director may carry out regular inspections to ensure that the requirements established by these regulations in relation to the manufacture, assembly or modification of a veterinary medicinal product or active substance are complied with.
(9)With respect to the manufacture of veterinary medicinal products and active substance, the Director may: (
  1. a)inspect the manufacturing establishment and any other premises at any reasonable time; (
  2. b)examine any relevant document; (
  3. c)take any sample deemed necessary and if necessary, submit it to designated laboratories for testing; (
  4. d)open or, and examine or, and seize any article believed to be in violation of these regulations or for obtaining evidence; (
  5. 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; (
  6. f)carry out any other activity as he may deem appropriate for the proper execution of his duties and responsibilities as provided by these regulations; (
  7. 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; (
  8. 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; and (
  9. i)draw up a report of the inspection within thirty
(30)working days of the inspection and forward a copy of such report to the holder of the authorisation.
(10)Except in urgent cases, an inspection shall be carried out in the presence of a qualified person responsible for manufacturing and [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS batch release referred to in Article 97 of Regulation (EU) 2019/6, or his representative.
(11)Subject to the provisions of these regulations, every authorisation shall, unless previously renewed or revoked, continue to be valid until such time as it is renewed by the Director following an inspection.
(12)Unless otherwise determined by the Director based on the conclusions of an inspection, the authorisation shall be valid for a period of three
(3)years.
(13)Following an inspection the Director may renew the authorisation, with or without modifications, for such a further period as specified.
(14)The holder of the manufacturing authorisation, or the manufacturer of active substance shall: (
  1. a)excipients; verify the authenticity and quality of the (
  2. b)keep a record of all suspected adverse reactions and adverse reactions on humans relating to the use of veterinary medicinal products that are brought to his attention and report them promptly to the Director in no later than fifteen days
(15)following receipt of the information; (
  1. c)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; (
  2. d)record and investigate any complaint concerning quality defects; and (
  3. e)perform other responsibilities established by the Director from time to time. as may be
(15)Manufacturing authorisation holders shall be regarded as producers and therefore shall be held liable for damages in cases and under the conditions set forth in the Consumer Affairs Act.
(16)The Director may require from the applicant further information concerning the particulars supplied pursuant to Article 89
(2)of Regulation (EU) 2019/6 and the qualified person referred to in Article 97 of Regulation (EU) 2019/6:    Cap. 378. 15 16 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS Provided that before the applicant provides the requested information, the manufacturing authorisation shall be suspended. Qualified person. 13.
(1)When more than one
(1)qualified person is nominated in accordance with Article 97 of Regulation (EU) 2019/6, the application shall clearly indicate the specific responsibilities of each person: Provided that the qualified person may nominate another person similarly qualified to act as his representative and shall notify the Director of such nomination within one
(1)working day.
(2)A person carrying out duties of a qualified person before the coming into force of these regulations shall continue to carry out his duties without the requirements of the provisions of Article 97
(2)
(3)of Regulation (EU) 2019/6.
(3)If the qualified person started following a course prior to the date on which these regulations became applicable, he may be considered as qualified to carry out the duties thereof: Provided that he shall have been previously engaged in one
(1)or more of the following activities for at least two
(2)years before the date on which these regulations became applicable: (a) in one
(1)or more undertakings with a manufacturing authorisation and production supervision; and, or (b) qualitative and quantitative analysis of active substances, and the necessary testing and checking to ensure the quality of veterinary medicinal products: Provided further that if the person concerned has acquired the practical experience referred to before the date of the coming into force of these regulations, he shall complete a further one
(1)year’s practical experience in accordance with the conditions referred to in sub-regulation
(1)immediately before he engages in such activities.
(4)The qualified person shall ensure that standards of good practice in manufacturing are complied with at all times. Products in transit. 14.
(1)When veterinary medicinal products are in transit for the sole purpose of export and without them being placed on the European Union market, the provisions of Article 88 of Regulation (EU) 2019/6 shall apply, even though the product remains intact and no manufacturing activities are carried out: Provided that such products may be exempted from the VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115 17 provisions of Article 88 of Regulation (EU) 2019/6 when the transit is for the sole purpose of re-export, is affected within the freeport, free trade zones or customs tax warehouses. However, in such instances the wholesale distribution authorisation provided for in Article 99 of Regulation (EU) 2019/6 shall nonetheless be required by the company engaging in the process.
(2)In cases where manufacturing activity in relation to the products in transit for the sole purpose of export is carried out, the manufacturing authorisation provided for in Article 88 of Regulation (EU) 2019/6 shall be required, even if the operations are affected within the freeport, free trade zones or customs tax warehouses.
(3)The veterinary medicinal products which are in transit for the sole purpose of export which qualify for the exemption provided for in this regulation may be also exempted from the provisions of Article 5 of Regulation (EU) 2019/6.
(4)The Director shall be notified by the wholesale distributor in the manner indicated by the Director if such an activity is ever conducted. 15. The retail supply of veterinary medicinal products shall be conducted only from or through licensed veterinary pharmacies in the territory of Malta, licensed veterinary establishments, the establishments provided for in regulation 18
(2)and by veterinary surgeons in relation to animals under their care, in the course of their professional visits or visits by clients. Retail supply of veterinary medicinal products. 16.
(1)Veterinary medicinal products may only be dispensed from the premises and persons provided for in regulation 18. Dispensing.
(2)A veterinary surgeon may dispense veterinary medicinal products during his professional visits or when clients visit him: Provided that the veterinary surgeon shall supply the quantities of veterinary medicinal products only for treatments to animals under his care. If the type of the packaging is such that the veterinary surgeon cannot supply lesser quantities thereof, the veterinary surgeon may supply the animal owner and, or the keeper and, or the carer with the quantities needed for the full treatment of the condition.
(3)In any doubtful situation and within the limits of his responsibilities, when dispensing veterinary medicinal products, the dispenser shall be satisfied that the person who will use the product is competent to do so safely and intends to use it for a purpose for which 18 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS it is authorised or indicated by the veterinary surgeon.
(4)When dispensing veterinary medicinal product, the dispenser shall advise the receiver of the product on the dosing, safe administration of the product and on any warnings or contraindications on the label or package leaflet, including information on any applicable withdrawal periods.
(5)The dispenser shall provide to the Director any information about veterinary medicinal products, including data on sales and use of veterinary medicinal products upon his request.
(6)When dispensing veterinary medicinal products and medicinal products for human use containing antimicrobials, the dispenser shall be satisfied that all necessary precautions have been taken to minimise the risks of antimicrobial resistance, in particular the use of critically important antimicrobials.
(7)If the dispenser is not the veterinary surgeon issuing the veterinary prescription and the dispenser has concerns about the veterinary prescription presented to him, he shall resolve them with the prescribing veterinary surgeon before dispensing the product.
(8)If a veterinary medicinal product is supplied in a container other than that specified in the marketing authorisation, the dispenser shall ensure that the container is suitably labelled and shall supply sufficient written information.
(9)The dispenser shall be present when a veterinary medicinal product is dispensed unless: (
  1. a)each transaction is authorised individually before the product is supplied; and (
  2. b)the dispenser is satisfied dispensing it over is competent to do so. that the person
(10)The Director may request the dispenser to provide any samples of the veterinary medicinal products. Prescribing. 17.
(1)No person shall prescribe veterinary medicinal products or medicinal products for human use unless that person is a veterinary surgeon.
(2)The prescribing of veterinary medicinal products or medicinal products for human use shall be made only on the veterinary prescription provided for in regulation 31. VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115
(3)A veterinary surgeon may only prescribe veterinary medicinal products or medicinal products for human use if that veterinary surgeon has examined those particular animals and he shall accept clinical responsibility for the treatment of the animals under his care.
(4)Veterinary medicinal products or medicinal products for human use may not be used for more than one
(1)treatment under the same veterinary prescription.
(5)Before prescribing veterinary medicinal products or medicinal products to be administered to animals which require a veterinary prescription, a veterinary surgeon shall carry out a clinical assessment of the animal under his care.
(6)Before prescribing a veterinary medicinal products or medicinal products for human use, the veterinary surgeon shall be satisfied that: (
  1. a)the use of the veterinary medicinal products or medicinal products for human use is justified for the species concerned on veterinary grounds; (
  2. b)the administration of the veterinary medicinal products or medicinal products for human use is not incompatible with a previous treatment or use and that there is no contra-indication or interaction where several veterinary medicinal products and medicinal products for human use are used; (
  3. c)the veterinary medicinal products or medicinal products for human use are prescribed only in such quantities as are necessary for the purpose of the treatment; and (
  4. d)all necessary precautions shall be taken to minimise the risks of antimicrobial resistance and that the prudent use of veterinary medicinal products or medicinal products for human use containing antimicrobials have been taken in consideration, in particular where critically important antimicrobials are being used.
(7)Within the limits of his responsibility, when prescribing veterinary medicinal products or medicinal products for human use, a veterinary surgeon shall be satisfied that the person who will administer the products on the respective animal is competent to do so safely and intends to use it for a purpose for which it is authorised or directed by the veterinary surgeon. 19 20 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS
(8)When prescribing veterinary medicinal products or medicinal products for human use containing antimicrobials, a veterinary surgeon shall consider the guidelines as issued by the Director and other relevant national, European and international organisations with regard to critically important antimicrobials.
(9)When preparing a veterinary prescription, the prescribing veterinary surgeon shall advise the receiver of the veterinary prescription on the safe administration of the veterinary medicinal product or medicinal product for human use and on any warning or contra-indication associated with their use. Distribution categories of veterinary medicinal product. 18.
(1)In the territory of Malta there shall be the following four
(4)distribution categories of veterinary medicinal product: (
  1. a)prescription-only-medicine, veterinary surgeon and pharmacist, abbreviated to "POM-VP"; (
  2. b)prescription-only-medicine, veterinary surgeon, abbreviated to "POM-V"; (
  3. c)over-the-counter-medicine, abbreviated to "OTC"; (
  4. d)general sales, abbreviated to "GS". and
(2)The supply of veterinary medicinal products for each distribution category shall be made as follows: (
  1. a)POM-VP shall only be prescribed and, or dispensed by a veterinary surgeon or dispensed by a pharmacist according to the terms of a veterinary prescription. The premises from where, or through which, these veterinary medicinal products may be supplied to the public shall be licensed veterinary pharmacies and licensed veterinary establishments; (
  2. b)POM-V shall only be prescribed, dispensed and administered by a veterinary surgeon. The premises from where, or through which, these veterinary medicinal products may be supplied shall be licensed veterinary pharmacies and licensed veterinary establishments; (
  3. c)OTC may be dispensed without a veterinary prescription. The persons who may dispense these veterinary medicinal products shall be veterinary surgeons, pharmacists VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115 and suitably learned persons under the supervision of a pharmacist or a veterinary surgeon. The premises from where, or through which, these veterinary medicinal products may be supplied to the public shall be licensed veterinary pharmacies and licensed veterinary establishments; (
  4. d)GS may be dispensed without a veterinary prescription. The persons who may dispense these veterinary medicinal products shall be veterinary surgeons, pharmacists and suitably learned persons. Veterinary medicinal products that fall under this category may be supplied to the public from, or through, licensed veterinary pharmacies, licensed veterinary establishments, registered pet shops, registered shops that retail animal care products and approved feed business operators where medicated feeds are manufactured, sold or traded: Provided that, a person carrying out the activities of the suitably learned person on the date on which his qualifications of a suitably learned person are published shall be eligible to continue to engage in such activities.
(3)The Director shall determine the distribution category of veterinary medicinal products when processing application forms for the authorisation or registration thereof: Provided that this shall not preclude the Director from changing the distribution category of any veterinary medicinal product at any stage after authorisation or registration has been granted.
(4)The marketing authorisation holders and holders of registration in accordance with Article 116 of Regulation (EU) 2019/6 may request the Director to amend the distribution category previously assigned.
(5)When determining the distribution category of veterinary medicinal products, the Director may seek the advice from suitable expert committees and may take in consideration the guidelines of other national, European and international relevant bodies.
(6)Different pack sizes of the same marketing authorisation may be assigned a different distribution category.
(7)The Director may issue guidelines on the criteria based on Article 34 of Regulation (EU) 2019/6 for the categorisation of a veterinary medicinal product.
(8)The holders of a wholesale distribution authorisation 21 22 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS shall distribute veterinary medicinal products only to those premises authorised to retail veterinary medicinal products and shall distribute only the category or categories of veterinary medicinal products that are authorised to be retailed from each type of premises in accordance with these regulations. Advertising. 19.
(1)shall include: Any advertising of a veterinary medicinal product (
  1. a)the trade name; (
  2. b)a list of active ingredients; (
  3. c)the pharmaceutical form; (
  4. d)the major indications for use; (
  5. e)the dosage and method of use; (
  6. f)side contraindications; effects, (
  7. g)the name and authorisation holder; and warnings, address precautions of the and marketing (
  8. h)any research and, or publications on the use of the active substance.
(2)All the information contained in the documentation referred to in this regulation shall be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his own opinion of the therapeutic value of the veterinary medicinal product concerned.
(3)Quotations as well as tables and other illustrative matter taken from scientific works for use in the documentation provided for in this regulation shall be faithfully reproduced.
(4)The person who advertises veterinary medicinal products shall: (a) keep for a period of not less than five
(5)years a sample of all advertisements emanating from his undertaking together with a statement indicating to whom the advert is addressed, the method of dissemination and the date of first dissemination; and (b) ensure that any decision taken and any conditions VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115 condition imposed by the Director are immediately and fully complied with.
(5)The Director may request any of the information provided for in this regulation at any time. 20.
(1)

Article 119

(1)and
(9)of Regulation (EU) 2019/6, veterinary medicinal products may be exempted from the requirements established by Article 5 of Regulation (EU) 2019/6 if these are intended to be used as samples and, or as demonstration packs that are given directly to veterinary surgeons or other persons who are allowed to supply veterinary medicinal products during sponsored events by pharmaceutical companies or during professional visits to those persons who are authorised to prescribe or dispense veterinary medicinal products: Provided that this exemption shall be granted by the Director following a request from the wholesale distributor of veterinary medicinal products in the manner indicated by the Director before the activity takes place, and the exemption shall not be used before the product has been registered.
(2)The Director shall only register the product when: (
  1. a)the veterinary medicinal products are labelled with the following words "Free sample - Not for sale" or "Demonstration pack - Not for sale", as the case may be; (
  2. b)each sample or demonstration pack shall not be bigger than its smallest presentation on the market; (
  3. c)each sample or demonstration pack shall be accompanied by a copy of the summary of product characteristics; (
  4. d)veterinary medicinal products containing psychotropic or narcotic drugs cannot be distributed as samples or demonstration packs; (
  5. e)starter packs shall not be regarded as samples and shall not be labelled as such; (
  6. f)during visits by sales representatives, the persons visited should be given information about the use of the veterinary medicinal products, with particular reference to any adverse reaction; (
  7. g)the information provided with the samples or Samples or demonstration packs. 23 24 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS demonstration packs shall not be promotional in nature; (
  8. h)the applicant shall be a holder of a wholesale distribution authorisation; and (
  9. i)the validity period of the authorisation shall be one
(1)year from the first consignment thereof.
(3)If any veterinary medicinal product registered in accordance with this regulation is administered on a food producing animal, that animal shall be excluded permanently from the food chain. Promotion. 21. It shall not be lawful for a person authorised to distribute or retail veterinary medicinal products to enter into any form of contractual agreement with animal keepers and, or owners and, or carers in order to supply to them veterinary medicinal products. Wholesale distribution and brokering of veterinary medicinal products. 22.
(1)Only authorised or registered veterinary medicinal products shall be wholesale distributed in the territory of Malta.
(2)Persons may only apply for a wholesale distribution authorisation of veterinary medicinal products if they are established in the territory of Malta and have a permanent address: Provided that, this regulation shall not be applicable to small quantities of veterinary medicinal products supplied from one
(1)retailer to another established in the territory of Malta in accordance with a decision which shall be stipulated by the Director. Application for a wholesale distribution authorisation. 23.
(1)An application for the grant of a wholesale distribution authorisation provided for in Article 99
(1)of Regulation (EU) 2019/6 shall be made in the manner provided by the Director, and shall include such information, documents and other material as provided for by these regulations and Regulation (EU) 2019/6.
(2)An application for the grant of a wholesale distribution authorisation shall include the following: (
  1. a)the name and address of the applicant; (
  2. b)the name of the responsible person provided for in Article 100
(2)(
  1. a)of Regulation 2019/6; (
  2. c)the address of the premises that is to be used for the purpose of wholesale distribution; (
  3. d)other relevant permits for the premises that is to be used for the purpose of wholesale distribution from other VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115 Maltese regulatory entities; (
  4. e)a licence, permit or equivalent document from the financial services or an equivalent authority if the applicant is a limited liability company; (
  5. f)the equipment and control facilities as may be required in these regulations; (
  6. g)information, documentation or evidence to prove that the premises is suitable and adequate, and that there are suitable facilities, installations and equipment so as to ensure proper conservation and distribution of veterinary medicinal products as determined by the Director; (
  7. h)the pharmaceutical forms of the products to be distributed, in particular any sterile product and product requiring storage below eight Centigrade (8º), if applicable; (
  8. i)the details of narcotic or psychotropic drugs, blood, or veterinary immunological medicinal products; (
  9. j)the approval from the authority in the territory of Malta responsible for planning and building permits, if applicable; and (
  10. k)the activities related with the wholesale distribution of veterinary medicinal products intended to be carried out by the applicant: Provided that the Director may request from the applicant any other relevant information or additional document, which is deemed necessary for the purpose of these regulations at any time.
(3)The premises used for the wholesale distribution of veterinary medicinal products shall not be interconnected with other premises which are used for other commercial activities or for habitation: Provided that, interconnection with any other premises which is used for other commercial activities or for habitation may be allowed when the scale of activities and the commercial turnover of veterinary medicinal products may be reasonably expected to be below a certain threshold established by the Director by means of a notice in the Gazette. In such cases, the physical connection between the premises shall be kept to a minimum whilst the different areas shall be clearly demarcated and properly marked so that a visible distinction 25 26 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS can be made clearly and unequivocally: Provided further that, the provisions of this subregulation shall not apply in respect of existing premises before the coming into force of these regulations and which cannot be structurally altered as to comply with the said provisions.
(4)The Director may revoke a wholesale distributor authorisation granted through such an exemption at any time. Granting of a wholesale distribution authorisation. 24.
(1)No person shall act as a wholesale distributor of veterinary medicinal products unless a wholesale distribution authorisation is issued by the Director.
(2)The Director shall carry out inspections at the premises indicated in the application and shall not issue the authorisation until he is satisfied that such premises is in conformity with the requirements established in Regulation (EU) 2019/6 and these regulations.
(3)The authorisation granted shall include the premises and the applicable activities.
(4)A person who intends to acquire a wholesale distribution authorisation shall apply with the Director by means of the application form issued by the said Director and shall pay the applicable fee.
(5)All the premises, equipment and documents used by the wholesale distributor shall be readily accessible at all reasonable times for inspection by the Director. Obligations of the wholesale distributor of veterinary medicinal products. 25.
(1)products shall: The wholesale distributor of veterinary medicinal (
  1. a)comply with the requirements as stipulated by Article 101 of Regulation (EU) 2019/6; (
  2. b)immediately inform the Director of any change in the details given in the original application within one
(1)working day of the said change; (
  1. c)provide the Director access to his premises at any reasonable time to carry out inspections as necessary; (
  2. d)provide any sample of the veterinary medicinal products which are distributed or were distributed or intended to be distributed or found in the authorized premises at the request of the Director; VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115 (
  3. e)provide any information and document about veterinary medicinal products, including data on sales, distribution and use of veterinary medicinal products as requested by the Director; (
  4. f)inform the Director of any intention to relocate the premises authorised for the wholesale distribution of veterinary medicinal products three
(3)months prior relocation and shall apply for a new authorisation in accordance with regulation 23; and (g) carry out any other responsibility as may be established from time to time by the Director.
(2)When the veterinary medicinal product is obtained from the manufacturer or importer, the wholesale distributor shall verify that the manufacturer or importer holds a valid manufacturing authorisation.
(3)When the veterinary medicinal product is obtained through brokering, the wholesale distributor shall verify that the broker satisfies the requirements set out in these regulations and that he has a valid registration for the activity of brokering.
(4)When the veterinary medicinal product is obtained from another wholesale distributor of veterinary medicinal products, the wholesale distributor shall verify that the other wholesale distributor of veterinary medicinal products holds a valid wholesale distribution authorisation.
(5)When distributing veterinary medicinal product to persons entitled to retail veterinary medicinal products in the territory of Malta the wholesale distributor shall keep record of at least the name of veterinary medicinal product, name of recipient, pharmaceutical form, batch number, expiry date and quantities supplied in respect of each transaction.
(6)A wholesale distributor shall exercise all necessary precautions when veterinary medicinal products are received from a third country but not imported for the sole purpose of export, in order to ensure that these veterinary medicinal products do not in any way end up on any Member State market.
(7)The Director may request the wholesale distributor to provide a letter of access issued by the marketing authorisation holder granting the wholesale distribution authorisation holder the use of such marketing authorisation in respect of each veterinary medicinal 27 28 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS product he distributes and which is obtained directly from the marketing authorisation holder or his legal representative. Renewal, validation, suspension or revocation of a wholesale distribution authorisation. 26.
(1)Every authorisation granted under these regulations shall, unless previously renewed or revoked remain valid until such time as it is renewed by the Director.
(2)Unless otherwise determined by the Director based on the conclusions of an inspection, the authorisation shall be valid for a period of three
(3)years.
(3)The Director may renew the authorisation with or without modifications for such a further period as specified by the Director, or refuse to renew the authorisation: Provided that in the case that the authorisation is not renewed, the Director shall stipulate corrective measures as necessary, and he may suspend the authorisation until it is confirmed that the holder of the authorisation is in compliance with these regulations and Regulation (EU) 2019/6.
(4)The Director may suspend or revoke the authorisation granted under these regulations for such period as it may be determined in any of the following instances: (
  1. a)where the information stated in the application on which the authorisation was issued was false or incomplete in a particular detail; (
  2. b)where a material change of circumstance has occurred in relation to any of that information; (
  3. c)where any condition of the authorisation has been contravened; (
  4. d)where the requirements in relation to the authorisation as provided for by these regulations and Regulation (EU) 2019/6 have not been complied with; and (
  5. e)where conditions of good practice in wholesale distribution, particularly those established by the Commission in the implementation of Regulation (EU) 2021/1248 are not being complied with: Provided that the Director may revoke or suspend the authorisation for any other matter that he deems appropriate. VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115 27.
(1)The responsible person shall be a pharmacist enlisted in the Register of Pharmacists in terms of article 17 of the Health Care Professions Act.
(2)29 Duties of the responsible person. Cap. 464. The responsible person shall: (
  1. a)ensure that the wholesale authorisation conditions are adhered to; distribution (
  2. b)be permanently and continuously at the disposal of the holder of the wholesale authorisation; (
  3. c)nominate, if necessary, another person to act as his representative and inform the Director of such nomination within one
(1)working day from date of nomination; (d) inform the Director within one
(1)working day in the case that another representative be replacing the previous representative temporarily or permanently; (e) not abandon his duties without giving prior notice in writing to the Director and to the wholesale distributor at least two
(2)weeks in advance; (f) have in place a contact number which is available twenty-four
(24)hours a day and seven
(7)days a week in case of emergencies which shall also be provided to the Director; and (g) upon request by the Director, provide any data in his possession relating to the importation, sale, distribution, use and administration of any type of veterinary medicinal product. 28.
(1)Without prejudice to any provision of these regulations, the Director may establish additional requirements for the wholesale distribution of the following veterinary medicinal products and publish them in the Gazette: (
  1. a)veterinary medicinal products containing strong sedatives, narcotic drugs or psychotropic drugs; (
  2. b)veterinary medicinal products used for euthanasia; (
  3. c)veterinary medicinal products derived from blood; (
  4. d)immunological veterinary medicinal products; (
  5. e)such other veterinary medicinal products or class or classes of veterinary medicinal products as the Minister may prescribe; and Other medicinal products. 30 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS (
  6. f)veterinary medicinal products containing antimicrobials, in particular those that are deemed critical for human health.
(2)Without prejudice to any provision of these regulations, the Director shall take the necessary measures in order to prevent veterinary medicinal products that are introduced into the European Union but which are not intended to be placed on the market of the European Union from entering into circulation if there are sufficient grounds to suspect that those products are falsified. These measures shall include the application of these regulations to warehouses situated in the free port, free trade zones or customs tax warehouses authorized to store veterinary medicinal products. These measures may be issued in the Gazette through a notice.
(3)When the Director has valid reason to believe that circumstances may exist which would render necessary the consideration of whether the wholesale distribution authorisation should be varied, suspended or revoked, the Director may serve the holder a notice requiring him, within such period as may be specified in the notice, to provide any information specified in the notice. Brokering of veterinary medicinal products. 29.
(1)Any person intending to engage in the brokering of veterinary medicinal products shall have a permanent address in the territory of Malta and shall register his activity with the Director before the activity takes place.
(2)The person intending to engage in the brokering of veterinary medicinal products shall send a request to the Director in the in the manner indicated by the Director to register his activity, and the request shall include: (
  1. a)the name of the applicant and, if applicable, the corporate name; (
  2. b)the permanent address in the territory of Malta; (
  3. c)the contact details of the applicant; and (
  4. d)the payment of the relevant fee: Provided that the Director may request, from time to time, any other relevant information or additional document which he may deem necessary for the purpose of the registration.
(3)The Director shall process the request for registration of a broker within ninety
(90)days of receipt of the request which shall be VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115 suspended in cases where the applicant is requested to provide additional data.
(4)The Director may carry out an inspection at the permanent address of the applicant before registering the activity of the applicant to ensure accurate identification and location, and that the applicant has the necessary means to conduct the activity and is in compliance with these regulations.
(5)Where the Director notifies that an inspection shall be carried out, the activity shall not begin before the Director has notified that the activity may start. In such a case, the Director shall carry out the inspection and communicate to the broker the results of the inspection within ninety
(90)days of the notification of his intention to carry out the inspection. When within ninety
(90)days of receipt of the request the Director has not notified that an inspection shall be carried out, the activity may start.
(6)The broker shall: (a) inform the Director of any change in the details given in the original registration within one
(1)working day; (
  1. b)provide the Director access to his permanent address at any reasonable time; (
  2. c)maintain records for any dealings in veterinary medicinal products as may be provided for by these regulations, and have such records readily available for inspection by the Director for a period of not less than five
(5)years; (
  1. d)provide any information about the brokering veterinary medicinal products, including information about the amounts and identity of veterinary medicinal products brokered; (
  2. e)abide by other responsibilities as may be established from time to time by the Director; and (
  3. f)informs the Director and, where applicable, other related parties, of veterinary medicinal products he suspects to be falsified.
(7)Unless otherwise determined by the Director, the registration granted in accordance with this regulation shall be valid for a period of three
(3)years. 30.
(1)This regulation shall apply to veterinary medicinal products which require a veterinary prescription as per Article 34 of Veterinary prescription. 31 32 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS Regulation (EU) 2019/6 and to products or substances that may not be classified as veterinary medicinal products, but which may be deemed by the Director to require a veterinary prescription for their administration to animals: Provided that this regulation shall not apply to veterinary prescriptions issued for the preparation, placing on the market and use of medicated feed.
(2)No person shall alter a veterinary prescription unless authorized to do so by the veterinary surgeon who has issued the prescription: Provided that the veterinary surgeon who authorised that the veterinary prescription be altered and the dispenser shall keep a note to this effect.
(3)Veterinary prescriptions shall be printed or handwritten in indelible ink, signed in original handwriting and rubber stamped by the veterinary surgeon who issues the veterinary prescription: Provided that in the event that the veterinary prescription is printed, the signature and rubber stamp of the veterinary surgeon shall be made in ink which is different from the printing ink: Provided further that this regulation shall not be applicable to electronic veterinary prescription.
(4)In addition to the elements listed in Article 105
(5)of Regulation (EU) 2019/6, a veterinary prescription issued in the territory of Malta shall also include the following: (
  1. a)the name of veterinary medicinal products or medicinal products for human use dispensed, including their active substances and pharmaceutical form and strength; (
  2. b)the quantity dispensed or the number of packs, including pack size; (
  3. c)the disease treated or prevented; (
  4. d)the name, signature and stamp of the dispenser of the veterinary medicinal products or medicinal products for human use, including the professional number, if available; (
  5. e)the name and address of premises from where the veterinary medicinal products or medicinal products for human VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115 use are dispensed; and (
  6. f)the dates when the veterinary medicinal products or medicinal products for human use were dispensed.
(5)The dispenser shall not accept verbal instructions unless all the following conditions are satisfied: (
  1. a)that the dispenser is satisfied that the verbal instruction comes from a veterinary surgeon who by reason of an emergency is unable to furnish a veterinary prescription; (
  2. b)that the veterinary surgeon undertakes to furnish the dispenser with a veterinary prescription within forty-eight
(48)hours of the verbal instruction; and (c) that the product is dispensed in accordance with the directions of the veterinary surgeon.
(6)If not all the products on the veterinary prescription are dispensed, the dispenser shall make a note on the veterinary prescription to that effect.
(7)In case more than one
(1)product is listed on the veterinary prescription and not all of them are dispensed from a single
(1)place from where veterinary medicinal products can be retailed in accordance with the regulation 18, the dispenser shall make a note on the veterinary prescription to that effect. The dispenser shall note on the veterinary prescription which product and how many of the products were dispensed. The dispenser shall keep an accurate account of the course of action he has taken. The veterinary prescription may then be given to another dispenser by the customer, whereupon if the rest of the products are dispensed, it shall be considered as supplied in its entirety: Provided that this regulation shall apply also to products which are only partially dispensed from a single
(1)place with the remaining quantities of the same product dispensed from another place.
(8)A veterinary prescription for veterinary medicinal products that are not antimicrobials or that do not contain narcotic or psychotropic drugs shall be valid for a period not exceeding six
(6)months from the date of issue.
(9)A veterinary prescription for veterinary medicinal products containing narcotic or psychotropic drugs shall be valid for a 33 34 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS period not exceeding one
(1)month from the date of issue.
(10)Pursuant to Article 105
(12)of Regulation (EU) 2019/6, a veterinary medicinal product or a medicinal product for human use classified as subject to a veterinary prescription may be administered personally by the veterinary surgeon without a veterinary prescription, provided that they do not contain antimicrobials or narcotic or psychotropic drugs.
(11)The veterinary surgeon, dispenser and the animal owner or keeper shall keep the veterinary prescriptions for a period of not less than five
(5)years and shall be made readily available to the Director upon his request. Veterinary prescription established by the Director. 31.
(1)The Director shall provide the veterinary prescriptions on which veterinary surgeons shall prescribe veterinary medicinal products or medicinal products for human use.
(2)The printed version of a veterinary prescription shall remain valid until such time as determined by the Director, who may decide that it shall be substituted by an electronic version where all the regulations apply mutatis mutandis.
(3)The electronic veterinary prescription shall be established by the Director and used by the persons authorised to prescribe and dispense.
(4)An electronic veterinary prescription shall be issued in such a way as to unequivocally demonstrate the identity of the prescriber and dispenser of veterinary medicinal products.
(5)The Director shall keep copies of the veterinary prescriptions, in electronic format or hard copies, for a period of five
(5)years from the date of issue. Administration of veterinary medicinal products and medicinal product to animals. 32.
(1)Any person may administer veterinary medicinal products or medicinal products for human use which require a veterinary prescription without the veterinary prescription in urgent situations to alleviate suffering of the animal or impending spread of disease. Provided that a visit to the place where the animal is kept by the veterinary surgeon or a visit to the veterinary surgeon with the animal, depending on the best practicable circumstance, shall take place within forty-eight
(48)hours of such an administration.
(2)Veterinary surgeons and persons authorised to dispense a veterinary medicinal shall not supply for administration or administer VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115 themselves, as may be applicable, veterinary medicinal product unless such product is authorised by the Director.
(3)Products other than authorised veterinary medicinal products whose therapeutic effectiveness is merely anecdotal shall be used with caution. The administration of these products to food producing species shall be subject to the approval of the Director. The Director may ask the animal keeper to provide chemical data, clinical documentation and studies about the possible environmental impact as stipulated in the Gazette before granting his approval.
(4)Before prescribing a veterinary medicinal product or a medicinal product that contain critically important antimicrobials, the prescribing veterinary surgeon may take into account the results of diagnostic laboratory information.
(5)Every registered or licensed establishment where food producing animals are kept and are not excluded from the provisions of Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/ 2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/ EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) by the Director, and the establishments where animals are kept for display to the public or for breeding purposes in the territory of Malta shall have an appropriate animal health control programme designed and implemented under the responsibility of a professional registered with the Veterinary Surgeons Council: Provided that a register of the professionals responsible for each animal health control programme shall be kept by the Director: Provided further that the Director may, from time to time, publish requirements related to animal health control programmes in the Gazette through a notice. 35 36 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS
(6)Veterinary medicinal products and medicinal products for human use that are used in the registered or licensed establishments referred to in sub-regulation
(5)shall only be kept in such establishments.
(7)The records referred to in Article 108 of Regulation (EU) 2019/6 shall only be kept in the registered or licensed establishments where food producing animals are kept in accordance with subregulation
(5). Complaints received by the marketing authorisation holder. 33.
(1)The marketing authorisation holder shall implement a system for recording and reviewing complaints together with an effective system for recalling promptly and at any time the veterinary medicinal products in the distribution network.
(2)The marketing authorisation holder shall record and investigate any complaint concerning a quality defect.
(3)The marketing authorisation holder or his representative shall inform the Director of any quality defect that may result in a recall or restriction on the supply. In so far as possible, the countries where the products are marketed shall also be indicated. Safe disposal of veterinary medicinal products. 34. The Director shall issue guidelines for the disposal of waste derived from the manufacture, wholesale distribution, retail, research, diagnosis and use of veterinary medicinal products. These guidelines shall be issued in the Gazette through a notice. Access by the Director. 35.
(1)The persons referred to in Article 123
(1)of Regulation (EU) 2019/6, the holders of authorisation in accordance with regulation 6, the holders authorisation in accordance with Article 5
(6)of Regulation (EU) 2019/6, the holders of registration in accordance with Article 116 of Regulation (EU) 2019/6, the dispensers of veterinary medicinal products and the brokers of veterinary medicinal products shall allow the Director to carry out the controls referred to in the same provisions by making the premises, documents, installations and any equipment accessible at any reasonable time for inspection by the Director.
(2)When the Director has valid reason to believe that any of the persons referred to in sub-regulation
(1)is acting in contravention of any of the provisions of these regulations or Regulation (EU) 2019/ 6, he shall notify the person concerned in writing through a notice specifying the type of contravention and a time frame during which a valid justification for his actions is to be provided.
(3)When the person concerned fails to provide a valid VETERINARY MEDICINAL PRODUCTS [ S.L. 437.115 37 justification within such time as specified in the notice, or if the reply is unsatisfactory, the Director may suspend the activity of the concerned person by means of a written notice specifying the reasons for such suspension until such person is in compliance.
(4)The Director may also commence administrative or disciplinary measures against the person for failure to fulfil his obligations.
(5)Any authorisation or registration granted under these regulations or Regulation (EU) 2019/6 shall not be renewed unless remedial steps by the person to whom the notice is addressed are taken as specified in the notice. 36.
(1)Any person who contravenes or acts in breach of Articles 5
(1), 88
(1)(a) and (b), 93, 99
(1)and 134
(1)of Regulation (EU) 2019/6 and regulations 5, 6
(2), 8, 11, 12
(2), 15 and 16 shall be guilty of an offence against article 38 of the Act and shall be liable on conviction, to a fine (multa) exceeding five thousand euro (€5,000) but not exceeding ten thousand euro (€10,000), or to imprisonment for a term not exceeding six
(6)months, or to both such fine and imprisonment.
(2)Any person who contravenes or acts in breach of Articles 88
(1)(c) and 127
(1)of Regulation (EU) 2019/6 and regulations 6
(9), 17
(1), 22
(1)and 29
(1)shall be guilty of an offence against article 38 of the Act and shall be liable on conviction, to a fine (multa) exceeding thousand euro (€3,000) but not exceeding seven thousand euro (€7,000), or to imprisonment for a term not exceeding three
(3)months, or to both such fine and imprisonment.
(3)Any person who contravenes or acts in violation of regulation 35
(1)shall be guilty of an offence against article 35 of the Act and shall be liable on conviction, to a fine (multa) exceeding three thousand euro (€3,000) but not exceeding seven thousand euro (€7,000), or to imprisonment for a term not exceeding three
(3)months, or to both such fine and imprisonment.
(4)Any person who contravenes or acts in breach of Articles 58
(6),
(12)and
(13), 95
(1), 97
(1), 101, 108
(1),
(2)and
(5), and 121
(1)of Regulation (EU) 2019/6 and regulation 18
(8)shall be guilty of an offence against article 38 of the Act and shall be liable on conviction, to a fine (multa) exceeding five hundred euro (€500) but not exceeding one thousand euro (€1,000), or to imprisonment for a term not exceeding two
(2)months, or to both such fine and imprisonment.
(5)Any person who contravenes or acts in breach of any Offences, punishments and administrative penalties. 38 [ S.L. 437.115 VETERINARY MEDICINAL PRODUCTS other provision of Regulation (EU) 2019/6 and, or any of these regulations shall be guilty of an offence against article 38 of the Act and shall be liable on conviction, to a fine (multa) exceeding two hundred euro (€200) but not exceeding four hundred euro (€400), or to imprisonment for a term not exceeding one
(1)month, or to both such fine and imprisonment: Provided that the Director shall not be precluded from proceeding in accordance with the provisions of article 61 of the Act. Right to appeal.   Cap.
  2. Decisions in terms of these regulations shall be subject to a right of appeal before the Administrative Review Tribunal established in terms of article 5
(1)of the Administrative Justice Act by not later than twenty
(20)days from the service of the decision, wherein the person aggrieved by the said decision shall specify the reasons on the basis of which the said decision of the Director should be cancelled or modified: Provided that the decision shall become immediately applicable and enforceable and shall remain applicable throughout the term of appeal until final judgement by the Administrative Review Tribunal, unless such decision is reversed by the said Tribunal and, or the Court of Appeal or cancelled or modified by the Director:    Cap. 490. Provided further that any party, who feels aggrieved by a decision of the Tribunal, may on a point of law, appeal to the Court of Appeal in accordance with article 22 of the Administrative Justice Act.

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