The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:
(a) the name of the medicinal product followed by the common name where the product contains only one active substance and if its name is an invented name; where a medicinal product is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (baby, child or adult as appropriate) must be included in the name of the medicinal product;
(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 recognized action or effect and included in the guidelines published pursuant to Article 65. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated;
(e) the method and, if necessary, the route of administration;
(f) a special warning that the medicinal product must be stored out of reach of children;
(g) a special warning, if this is necessary for the medicinal product;
(h) the expiry date in clear terms (month/year);
(i) special storage precautions, if any;
(j) special precautions for disposal of unused medicinal products or waste materials from medicinal products, if appropriate;
(k) the name and address of the holder of the authorization for placing the medicinal product on the market;
(l) the number of the authorization for placing the medicinal product on the market;
(m) the manufacturer's batch number;
(n) in the case of self-medication, instructions on the use of the medicinal products.
1. The particulars laid down in Articles 54 and 62 shall appear on immediate packagings other than those referred to in paragraphs 2 and 3.
2. The following particulars at least shall appear on immediate packagings which take the form of blister packs and are placed in an outer packaging that complies with the requirements laid down in Articles 54 and 62.
- the name of the medicinal product as laid down in Article 54(a),
- the name of the holder of the authorization for placing the product on the market,
- the expiry date,
- the batch number.
3. The following particulars at least shall appear on small immediate packaging units on which the particulars laid down in Articles 54 and 62 cannot be displayed:
- the name of the medicinal product and, if necessary, the strength and the route of administration,
- the method of administration,
- the expiry date,
- the batch number,
- the contents by weight, by volume or by unit.
The particulars referred to in Articles 54, 55 and 62 shall be easily legible, clearly comprehensible and indelible.
Notwithstanding Article 60, Member States may require the use of certain forms of labelling of the medicinal product making it possible to ascertain:
- the price of the medicinal product,
- the reimbursement conditions of social security organizations,
- the legal status for supply to the patient, in accordance with Title VI,
- identification and authenticity.
The inclusion in the packaging of all medicinal products of a package leaflet shall be obligatory unless all the information required by Articles 59 and 62 is directly conveyed on the outer packaging or on the immediate packaging.
1. The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall include, in the following order:
(a) for the identification of the medicinal product:
- the name of the medicinal product, followed by the common name if the product contains only one active substance and if its name is an invented name; where a medicinal product is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (for example, baby, child, adult) must be included in the name of the medicinal product,
- a full statement of the active substances and excipients expressed qualitatively and a statement of the active substances expressed quantitatively, using their common names, in the case of each presentation of the medicinal product,
- the pharmaceutical form and the contents by weight, by volume or by number of doses of the product, in the case of each presentation of the product,
- the pharmaco-therapeutic group, or type of activity in terms easily comprehensible for the patient,
- the name and address of the holder of the authorization for placing the medicinal product on the market and of the manufacturer;
(b) the therapeutic indications;
(c) list of information which is necessary before taking the medicinal product:
- contra-indications,
- appropriate precautions for use,
- 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,
- special warnings;
this list must:
- take into account the particular condition of certain categories of users (e.g. children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions),
- mention, if appropriate, potential effects on the ability to drive vehicles or to operate machinery,
- detail those excipients, knowledge of which is important for the safe and effective use of the medicinal product and included in the guidelines published pursuant to Article 65;
(d) the necessary and usual instructions for proper use, in particular:
- the dosage,
- the method and, if necessary, route of administration,
- 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:
- the duration of treatment, where it should be limited,
- the action to be taken in the case of an overdose (e.g., symptoms, emergency procedures),
- the course of action to take when one or more doses have not been taken,
- indication, if necessary, of the risk of withdrawal effects;
(e) a description of the undesirable effects which can occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case; the patient should be expressly invited to communicate any undesirable effect which is not mentioned in the leaflet to his doctor or to his pharmacist;
(f) a reference to the expiry date indicated on the label, with:
- a warning against using the product after this date,
- where appropriate, special storage precautions,
- if necessary, a warning against certain visible signs of deterioration;
(g) the date on which the package leaflet was last revised.
2. Notwithstanding paragraph 1(b), the authority competent may decide that certain therapeutic indications shall not be mentioned in the package leaflet, where the dissemination of such information might have serious disadvantages for the patient.
Member States may not prohibit or impede the placing on the market of medicinal products within their territory on grounds connected with labelling or the package leaflet where these comply with the requirements of this Title.
1. One or more specimens or 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 authorities competent for authorizing marketing when the marketing authorization is requested.
2. The competent authority shall refuse the marketing authorization if the labelling or the package leaflet do not comply with the provisions of this Title or if they are not in accordance with the particulars listed in the summary of product characteristics.
3. All proposed changes to an aspect of the labelling or the package leaflet covered by this Title and not connected with the summary of product characteristics shall be submitted to the authorities competent for authorizing marketing. If the competent authorities have not opposed a proposed change within 90 days following the introduction of the request, the applicant may put the change into effect.
4. The fact that the competent authority do not refuse a marketing authorization pursuant to paragraph 2 or a change to the labelling or the package leaflet pursuant to paragraph 3 does not alter the general legal liability of the manufacturer or as appropriate the marketing authorization holder.
The outer packaging and the package leaflet may include symbols or pictograms designed to clarify certain information mentioned in Articles 54 and 59(1) and other information compatible with the summary of the product characteristics which is useful for health education, to the exclusion of any element of a promotional nature.
1. The particulars for labelling listed in Articles 54, 59 and 62 shall appear in the official language or languages of the Member State where the product is placed on the market.
The first subparagraph shall not prevent these particulars from being indicated in several languages, provided that the same particulars appear in all the languages used.
2. The package leaflet must be written in clear and understandable terms for the users and be clearly legible in the official language or languages of the Member State where the medicinal product is placed on the market.
The first subparagraph shall not prevent the package leaflet being printed in several languages, provided that the same information is given in all the languages used.
3. The competent authorities may exempt labels and package leaflets for specific medicinal products from the obligation that certain particulars shall appear and that the leaflet must be in the official language or languages of the Member State where the product is placed on the market, when the product is not intended to be delivered to the patient for self-administration.
Where the provisions of this Title are not complied with, and a notice served on the person concerned has remained without effect, the competent authorities of the Member States may suspend the marketing authorization, until the labelling and the package leaflet of the medicinal product in question have been made to comply with the requirements of this Title.
As necessary, the Commission shall publish guidelines concerning in particular:
- the formulation of certain special warnings for certain categories of medicinal products,
- the particular information needs relating to self-medication,
- the legibility of particulars on the labelling and package leaflet,
- methods for the identification and authentication of medicinal products,
- the list of excipients which must feature on the labelling of medicinal products and the way these excipients must be indicated.
These guidelines shall be adopted in the form of a Directive, in accordance with the procedure referred to in Article 121(2).
1. The outer carton and the container of medicinal products containing radionuclides 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 shall comply with the provisions set out in paragraphs 2 and 3.
2. The label on the shielding shall include the particulars mentioned in Article 54. In addition, the labelling on the shielding shall explain in full, the codings used on the vial and shall 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:
- the name or code of the medicinal product, including the name or chemical symbol of the radionuclide,
- the batch identification and expiry date,
- the international symbol for radioactivity,
- the name of the manufacturer,
- the amount of radioactivity as specified in paragraph 2.
The competent authority shall ensure that a detailed instruction leaflet is enclosed with the packaging of radiopharmaceuticals, radionuclide generators, radionuclide kits or radionuclide precursors. The text of this leaflet shall be established in accordance with the provisions of Article 59. In addition, the leaflet shall 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.
Without prejudice to the provisions of Article 69, homeopathic medicinal products shall be labelled in accordance with the provisions of this title and shall be identified by a reference on their labels, in clear and legible form, to their homeopathic nature.
1. In addition to the clear mention of the words "homeopathic medicinal product", the labelling and, where appropriate, the package insert for the medicinal products referred to in Article 14(1) shall bear the following, and no other, information:
- the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 1(5),
- name and address of the registration holder and, where appropriate, of the manufacturer,
- method of administration and, if necessary, route,
- expiry date, in clear terms (month, year),
- pharmaceutical form,
- contents of the sales presentation,
- special storage precautions, if any,
- a special warning if necessary for the medicinal product,
- manufacturer's batch number,
- registration number,
- "homeopathic medicinal product without approved therapeutic indications",
- a warning advising the user to consult a doctor if the symptoms persist during the use of the medicinal product.
2. Notwithstanding paragraph 1, Member States may require the use of certain types of labelling in order to show:
- the price of the medicinal product,
- the conditions for refunds by social security bodies.
TITLE VI
CLASSIFICATION OF MEDICINAL PRODUCTS
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
