MEDICINAL PRODUCTS (LABELLING AND PACKAGING) [ S.L.458.33 1 SUBSIDIARY LEGISLATION 458.33 MEDICINAL PRODUCTS (LABELLING AND PACKAGING) REGULATIONS 30th October, 2005 LEGAL NOTICE 393 of 2005, as amended by Legal Notices 372 of 2012, 351 of 2013 and 309 of 2024. 1.
(1)The title of these regulations is the Medicinal Products (Labelling and Packaging) Regulations. Title and scope.
(2)The scope of these regulations is transpose Directive 2001/ 83/EC, and to transpose amendments to Directive 2001/83/EC on the Community code relating to medicinal products for human use, brought about by Directive 2010/84/EU, as regards pharmacovigilance, Directive 2011/62/EU, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, and Directive 2012/26/EU, as as regards pharmacovigilance. 2. For the purposes of these regulations: "the Commission" means the Commission in accordance with Council Decision 1999/468/EC of 28 June, 1999; "common name" means the international non-proprietary name recommended by the World Health Organisation, or, if such name does not exist, the usual common name; "electronic package leaflet" means the package leaflet displayed in an electronic format in an official language or official languages of Malta and which is accessible through a machine-readable format displayed on the outer packaging of the medicinal product, and where the outer and immediate packaging is not in the official language or languages of Malta, it shall include the particulars to be found on the outer and immediate packaging of medicinal products in accordance with the provisions of these regulations; "immediate packaging" means the container or other form of packaging immediately in contact with the medicinal product; "labelling" means information on the immediate or outer packaging; "name of the 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 trade mark or the name of the marketing authorisation holder; "outer packaging" means the packaging into which the immediate packaging is placed; "package leaflet" means a leaflet containing information for the user which accompanies the medicinal product; "representative of the marketing authorisation holder" means the person, commonly known as local representative, designated by the marketing authorisation holder to represent him in the Member State concerned; Interpretation. Amended by: L.N. 309 of 2024. 2 MEDICINAL PRODUCTS (LABELLING AND PACKAGING) [ S.L.458.33 "strength of the medicinal product" means the content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form. Particulars on outer packaging. Amended by: L.N. 372 of 2012; L.N. 309 of 2024. 3. The following particulars shall appear on the outer packaging of medicinal products or, where there is no such outer packaging, on the immediate packaging: (
- a)the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the product contains up to three active substances, the international non-proprietary name (INN) shall be included, or, if one does not exist, the common name; (
- b)a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names; (
- c)the pharmaceutical form and the contents by weight, by volume or by number of doses of the product; (
- d)a list of those excipients known to have a recognised action or effect and which are included in the detailed guidance published by the Commission pursuant to Article 65 of Directive 2001/83/EC as amended by Directive 2004/27/EC. However, if the product is an injectable, or a topical or eye preparation, all excipients must be stated; (
- e)the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated; (
- f)a special warning that the medicinal product must be stored out of the reach and sight of children; (
- g)any special warning that may be necessary for the particular medicinal product; (
- h)the expiry date in clear terms (month/year); (
- i)special storage precautions, if any; (
- j)specific precautions, relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place; (
- k)the name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him; (
- l)the number of the marketing authorisation; (
- m)the manufacturer’s batch number; (
- n)in the case of non-prescription medicinal products, instructions for use; (
- o)for medicinal products other than MEDICINAL PRODUCTS (LABELLING AND PACKAGING) [ S.L.458.33 3 radiopharmaceuticals referred to in paragraph (p), safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to: (
- i)verify the authenticity of the medicinal product, and (
- ii)identify individual packs, as well as a device allowing verification of whether the outer packaging has been tampered with; (
- p)medicinal products subject to prescription shall bear the safety features referred to in paragraph (o), unless they have been listed in accordance with the procedure pursuant to Article 54a of Directive 2001/83/EC as amended. Medicinal products not subject to prescription shall not bear the safety features referred to in paragraph (o), unless, by way of exception, they have been listed in accordance with the procedure pursuant to Article 54a of Directive 2001/83/EC as amended, after having been assessed to be at risk of falsification; (
- q)the Licensing Authority may, for the purposes of reimbursement or pharmacovigilance, extend the scope of application of the unique identifier referred to in paragraph (
- o)to any medicinal product subject to prescription or subject to reimbursement; (
- r)the Licensing Authority may, for the purposes of reimbursement, pharmacovigilance and pharmacoepidemiology, use the information contained in the repositories system as may be established by the Commission referred to in Article 54a of Directive 2001/83/EC as amended; (
- s)the Licensing Authority may, for the purposes of patient safety, extend the scope of application of the anti-tampering device referred to in paragraph (
- o)to any medicinal product: Provided that where the outer packaging, or immediate packaging in the absence of an outer packaging, of the medicinal product includes the name of the product, the active substance or substances, pharmaceutical form and strength, in the Roman alphabet, all of the particulars in paragraphs (
- a)to (
- n)of this regulation may alternatively be included and accessed by means of the electronic package leaflet: Provided further that this electronic package leaflet may only be used for medicinal products procured for the national health service. 4. (
- a)The particulars laid down under regulation 3 shall appear on immediate packagings other than those referred to in paragraphs (
- b)and (
- c)hereof. Blister packs. Amended by: L.N. 309 of 2024. 4 MEDICINAL PRODUCTS (LABELLING AND PACKAGING) [ S.L.458.33 (
- b)At least the following particulars shall appear on the immediate packaging when this takes the form of a blister pack which is then placed in an outer packaging which complies with the provisions laid down in regulations 3 and 9: (
- i)the name of the medicinal product as laid down under regulation 3(a); (
- ii)the name of the holder of the marketing authorisation; (iii) the expiry date; (
- iv)the batch number. (
- c)In the case of small immediate packaging units on which the particulars laid down under regulations 3 and 9 cannot be displayed, the following particulars at least shall appear: (
- i)the name of the medicinal product as laid down in regulation 3(a), and, if necessary, the route of administration, (
- ii)the method of administration; (iii) the expiry date; (
- iv)the batch number; (
- v)the contents by weight, by volume or by unit: Provided that where the immediate packaging of the medicinal product includes the name of the product, the active substance or substances, pharmaceutical form and strength, in the Roman alphabet, all or any of the particulars in paragraphs (
- b)and (
- c)of this regulation, unless already included in the outer packaging may alternatively be included and accessed by means of the electronic package leaflet: Provided further that this electronic package leaflet may only be used for medicinal products procured for the national health service. Clarity of particulars. 5.
(1)The particulars referred to in regulations 3, 4 and 9 shall be easily legible, clearly comprehensible and indelible.
(2)The name of the medicinal product, as referred to in regulation 3(a), must also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package information leaflet is made available on request from patients’ organisations in formats appropriate for the blind and partially-sighted. Licensing Authority may require use of certain labelling forms. Added by: L.N. 372 of 2012. 5A. Notwithstanding the proviso to regulation 8
(2), the Licensing Authority may require the use of certain forms of labelling of the medicinal product making it possible to ascertain: (
- a)the price of the medicinal product; (
- b)the reimbursement conditions of social security organizations; MEDICINAL PRODUCTS (LABELLING AND PACKAGING) [ S.L.458.33 5 (
- c)the legal status for supply tothe patient, in accordance with Title VI of Directive 2001/83/EC, as amended; and (
- d)authenticity and identification in accordance with regulation 3(q), (
- r)and (s). 6. A package leaflet shall be included in the packaging of all medicinal products unless all the information required by regulations 7 and 9 is directly conveyed on the outer or immediate packaging: Inclusion of package leaflet. Amended by: L.N. 309 of 2024. Provided that the information in the package leaflet may alternatively be displayed and accessed by means of the electronic package leaflet when the medicinal product is procured for the national health service. 7.
(1)The package leaflet shall be drawn up in accordance with the summary of the product characteristics and shall include, in the following order: (
- a)for the identification of the medicinal product: (
- i)the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults. The common name shall be included where the product contains only one active substance and if its name is an invented name; (
- ii)the pharmaco-therapeutic group or type of activity in terms easily comprehensible for the patient; (
- b)the therapeutic indications; (
- c)a list of information which is necessary before the medicinal product is taken: (
- i)contra-indications; (
- ii)appropriate precautions for use; (iii) forms of interaction with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product; (
- iv)special warnings; (
- d)the necessary and usual instructions for proper use, and in particular: (
- i)the dosage; (
- ii)the method and, if necessary, route of administration; (iii) the frequency of administration specifying, if necessary, the appropriate time at which the medicinal product may or must be administered, and, as appropriate, depending on the nature of the product; (
- iv)the duration of treatment, where it should be Package leaflet. Amended by: L.N. 372 of 2012. 6 MEDICINAL PRODUCTS (LABELLING AND PACKAGING) [ S.L.458.33 (
- v)(
- vi)limited; the action to be taken in case of an overdose (such as symptoms, emergency procedures); what to do when one or more doses have not been taken; (vii) indication, if necessary, of the risk of withdrawal effects; (viii) a specific recommendation to consult the doctor or the pharmacist, as appropriate, for any clarification on the use of the product; (
- e)a description of the adverse reactions which may occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case; (
- f)a reference to the expiry date indicated on the label, with: (
- i)a warning against using the product after that date; (
- ii)where appropriate, special storage precautions; (iii) if necessary, a warning concerning certain visible signs of deterioration; (
- iv)the full qualitative composition (in active substances and excipients) and the quantitative composition in active substances, using common names, for each presentation of the medicinal product; (
- v)for each presentation of the product, the pharmaceutical form and content in weight, volume or units of dosage; (
- vi)the name and address of the marketing authorisation holder and, where applicable, the name of his appointed representatives in Malta; (vii) the name and address of the manufacturer; (
- g)where the medicinal product is authorised in accordance with the mutual recognition and decentralised procedure under different names in the Member States concerned, a list of the names authorised in each Member State; (
- h)the date on which the package leaflet was last revised; (
- i)for medicinal products included in the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included "This medicinal product is subject to additional monitoring". This statement shall be preceded by the black symbol referred to in Article 23 of Regulation (EC) No 726/ 2004 and followed by an appropriate standardized explanatory sentence. MEDICINAL PRODUCTS (LABELLING AND PACKAGING) [ S.L.458.33 For all medicinal products, a standardized text shall be included, expressly asking patients to communicate any suspected a d v e r s e r e a c t i o n t o h i s / h e r d o c t o r, p h a r m a c i s t , h e a l t h c a r e professional or directly to the national spontaneous reporting system referred to in regulations 24 and 25 of the Pharmacovigilance Regulations, and specifying the different ways of reporting available (electronic reporting, postal address and/or others) in compliance with regulation 25 of the Pharmacovigilance Regulations.
(2)S.L. 458.35 The list set out in subregulation
(1)(
- c)hereof shall: (
- a)take into account the particular condition of certain categories of users (children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions); (
- b)mention, if appropriate, possible effects on the ability to drive vehicles or to operate machinery; (
- c)list those excipients knowledge of which is important for the safe and effective use of the medicinal product and which are included in the detailed guidance published by the Commission pursuant to Article 65 of Directive 2001/83/EC as amended by Directive 2004/ 27/EC.
(3)The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use. 8.
(1)One or more mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the draft package leaflet, shall be submitted to the Licensing Authority, hereinafter called the Authority, when the marketing authorisation is requested. The results of assessments carried out in co-operation with target patient groups shall also be provided to the Authority.
(2)The Authority shall refuse the marketing authorisation if the labelling or the package leaflet do not comply with any of the provisions of these regulations or if they are not in accordance with the particulars listed in the summary of product characteristics: Provided that the Authority shall not prohibit or impede the placing on the market of medicinal products on grounds connected with labelling or the package leaflet where these comply with the requirements of these regulations.
(3)All proposed changes to an aspect of the labelling or the package leaflet covered by these regulations which are not connected with the summary of product characteristics shall be submitted to the Authority: Provided that if the Authority does not oppose a proposed change within ninety days of receipt of the request, the applicant may put the change into effect: Provided further that the legal liability of the manufacturer and the marketing authorisation holder shall remain unaltered if the Authority, contrary to the provisions of this regulation, approves a Mockups. 7 8 [ S.L.458.33 MEDICINAL PRODUCTS (LABELLING AND PACKAGING) marketing authorisation or a change to the labelling or the package leaflet. Promotion not to be included. 9. The outer packaging and the package leaflet shall not include elements of a promotional nature but may include symbols or pictograms designed to clarify certain information mentioned in regulations 3 and 7
(1)and other information compatible with the summary of the product characteristics which is useful for the patient. Labelling particulars. Amended by: L.N. 372 of 2012; L.N. 351 of 2013; L.N. 309 of 2024. 10.
(1)The particulars for labelling listed in regulations 3, 7 and 9 whether provided in printed form or by means of the electronic package leaflet shall appear in an official language or official languages of Malta: Provided that it will be possible for these particulars to be indicated in several languages, as long as the same particulars appear in all the languages used: Provided further that in the case of certain orphan medicinal products, the particulars listed under regulation 3 may on reasoned request, appear in one of the official languages of the Community.
(2)The package leaflet, or electronic package leaflet, shall be written and designed in such a way as to be clear and understandable, enabling users to act appropriately, when necessary even with the help of health professionals. The package leaflet, or electronic package leaflet, shall be clearly legible in an official language or official languages of Malta. When making use of the electronic package leaflet and including the details of the outer packaging through electronic means, the information shall be presented in the following order: the full details of the outer package, any information of the immediate packaging which is not found on the outer packaging, followed by the information in the package leaflet. No additional information shall be included: Provided that this shall not prevent the package leaflet or electronic package leaflet from being accessible or printed in several languages, provided that the same information is given in all the languages used.
(3)Where the medicinal product is not intended to be delivered directly to the patient, or where there are severe problems in respect of the availability of the medicinal product, the Licensing Authority may, subject to measures they consider necessary to safeguard human health, grant an exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet. The Licensing Authority may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of Malta. Suspension of marketing authorisation. 11. The Authority shall suspend the marketing authorisation if, after the serving of a notice on the marketing authorisation holder, the labelling and the package leaflet of the medicinal product in question do not comply with any of the provisions of these regulations. Such suspension shall cease to be effective as soon as MEDICINAL PRODUCTS (LABELLING AND PACKAGING) [ S.L.458.33 9 the labelling and package leaflet of the product in question have been made to comply with the requirements of these regulations. 12.
(1)In the case of radionuclides, the outer carton and container of the medicinal product shall be labelled in accordance with the regulations for the safe transport of radioactive materials laid down by the International Atomic Energy Agency. Moreover, the labelling, whether in printed form or by means of the electronic package leaflet shall comply with the provisions set out in subregulations
(2)and
(3). Radionuclides. Amended by: L.N. 309 of 2024.
(2)The label on the shielding shall include the particulars mentioned in regulation 3 and shall: (
- a)explain in full, the codings used on the vial, and (
- b)indicate, where necessary, for a given time and date, the amount of radioactivity per dose or per vial and the number of capsules, or, for liquids, the number of millilitres in the container.
(3)The vial shall be labelled with the following information: (
- a)the name or code of the medicinal product, including the name or chemical symbol of the radionuclide, (
- b)the batch identification and expiry date, (
- c)the international symbol for radioactivity, (
- d)the name and address of the manufacturer, (
- e)the amount of subregulation
(2). radioactivity as specified in 13. It shall be the duty of the Authority to ensure that a detailed instruction leaflet in accordance with the provisions of regulation 7 is enclosed with the packaging of radiopharmaceuticals, radionuclide generators, radionuclide kits and radionuclide precursors. T he leaflet shall also include any precautions to be taken by the user and the patient during the preparation and administration of the medicinal product and special precautions for the disposal of the packaging and its unused contents. Duty of the Authority. 14.
(1)Without prejudice to subregulation
(2), homeopathic medicinal products shall be labeled in accordance with the provisions of these regulations and shall be identified by a reference on their labels, in clear and legible form, to their homeopathic nature. Homeopathic medicinal products.
(2)In addition to the clear mention of the words "homeopathic medicinal product", the labelling and, where appropriate, the package insert for the homeopathic medicinal products which have qualified for a special simplified registration procedure referred to in regulation 10 of the Medicines (Marketing Authorisation) Regulations, shall bear the following, and no other, information: (
- a)the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia referred to in the definition of a homeopathic medicinal product; if the homeopathic S.L. 458.34 10 MEDICINAL PRODUCTS (LABELLING AND PACKAGING) [ S.L.458.33 medicinal product is composed of two or more stocks, the scientific names of the stocks on the labelling may be supplemented by an invented name; (
- b)name and address of the registration holder and, where appropriate, of the manufacturer; (
- c)method of administration and, if necessary, route; (
- d)expiry date, in clear terms (month, year); (
- e)pharmaceutical form; (
- f)contents of the sales presentation; (
- g)special storage precautions, if any; (
- h)a special warning if necessary for the medicinal product; (
- i)manufacturer’s batch number; (
- j)registration number; (
- k)homeopathic medicinal product without approved therapeutic indications; (
- l)Access to printed product information leaflet. Added by: L.N. 309 of 2024. a warning advising the user to consult a doctor if the symptoms persist. 15. Any person who obtains any product from a pharmacy or from any other place licensed to dispense medicinal products, which includes an electronic package leaflet, shall be entitled to request the product leaflet in a printed form without any additional cost.