TITLE V

LABELLING AND PACKAGE LEAFLET
Article 54
The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:
1. 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;
2. 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;
3. the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;
4. a list of those excipients known to have a recognized action or effect and included in the detailed guidance published pursuant to Article 65. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated;
5. the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated;
6. a special warning that the medicinal product must be stored out of the reach and sight of children;
7. a special warning, if this is necessary for the medicinal product;
8. the expiry date in clear terms (month/year);
9. special storage precautions, if any;
10. 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;
11. the name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him;
12. the number of the authorization for placing the medicinal product on the market;
13. the manufacturer's batch number;
14. in the case of non-prescription medicinal products, instructions for use;
15. for medicinal products other than radiopharmaceuticals referred to in Article 54a(1), safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to:
  - verify the authenticity of the medicinal product, and
  - identify individual packs,
as well as a device allowing verification of whether the outer packaging has been tampered with.
Article 54a
1
Medicinal products subject to prescription shall bear the safety features referred to in point (o) of Article 54, unless they have been listed in accordance with the procedure pursuant to point (b) of paragraph 2 of this Article.
Medicinal products not subject to prescription shall not bear the safety features referred to in point (o) of Article 54, unless, by way of exception, they have been listed in accordance with the procedure pursuant to point (b) of paragraph 2 of this Article, after having been assessed to be at risk of falsification.
2
The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c, measures supplementing point (o) of Article 54 with the objective of establishing the detailed rules for the safety features referred to in point (o) of Article 54.
Those delegated acts shall set out:
a
the characteristics and technical specifications of the unique identifier of the safety features referred to in point (o) of Article 54 that enables the authenticity of medicinal products to be verified and individual packs to be identified. When establishing the safety features due consideration shall be given to their cost-effectiveness;
b
the lists containing the medicinal products or product categories which, in the case of medicinal products subject to prescription shall not bear the safety features, and in the case of medicinal products not subject to prescription shall bear the safety features referred to in point (o) of Article 54. Those lists shall be established considering the risk of and the risk arising from falsification relating to medicinal products or categories of medicinal products. To this end, at least the following criteria shall be applied:
1. the price and sales volume of the medicinal product;
2. the number and frequency of previous cases of falsified medicinal products being reported within the Union and in third countries and the evolution of the number and frequency of such cases to date;
3. the specific characteristics of the medicinal products concerned;
4. the severity of the conditions intended to be treated;
5. other potential risks to public health;
c
the procedures for the notification to the Commission provided for in paragraph 4 and a rapid system for evaluating and deciding on such notification for the purpose of applying point (b);
d
the modalities for the verification of the safety features referred to in point (o) of Article 54 by the manufacturers, wholesalers, pharmacists and persons authorised or entitled to supply medicinal products to the public and by the competent authorities. Those modalities shall allow the verification of the authenticity of each supplied pack of the medicinal products bearing the safety features referred to in point (o) of Article 54 and determine the extent of such verification. When establishing those modalities, the particular characteristics of the supply chains in Member States, and the need to ensure that the impact of verification measures on particular actors in the supply chains is proportionate, shall be taken into account;
e
provisions on the establishment, management and accessibility of the repositories system in which information on the safety features, enabling the verification of the authenticity and identification of medicinal products, as provided for in point (o) of Article 54, shall be contained. The costs of the repositories system shall be borne by the manufacturing authorisation holders of medicinal products bearing the safety features.
3
When adopting the measures referred to in paragraph 2, the Commission shall take due account of at least the following:
a
the protection of personal data as provided for in Union law;
b
the legitimate interests to protect information of a commercially confidential nature;
c
the ownership and confidentiality of the data generated by the use of the safety features; and
d
the cost-effectiveness of the measures.
4
The national competent authorities shall notify the Commission of non-prescription medicinal products which they judge to be at risk of falsification and may inform the Commission of medicinal products which they deem not to be at risk according to the criteria set out in point (b) of paragraph 2 of this Article.
5
Member States may, for the purposes of reimbursement or pharmacovigilance, extend the scope of application of the unique identifier referred to in point (o) of Article 54 to any medicinal product subject to prescription or subject to reimbursement.
Member States may, for the purposes of reimbursement, pharmacovigilance or pharmacoepidemiology, use the information contained in the repositories system referred to in point (e) of paragraph 2 of this Article.
Member States may, for the purposes of patient safety, extend the scope of application of the anti-tampering device referred to in point (o) of Article 54 to any medicinal product.
Article 55
1
The particulars laid down in Article 54 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 point (a) of Article 54,
- 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 as laid down in point (a) of Article 54 and, if necessary, the route of administration,
- the method of administration,
- the expiry date,
- the batch number,
- the contents by weight, by volume or by unit.
Article 56
The particulars referred to in Articles 54, 55 and 62 shall be easily legible, clearly comprehensible and indelible.
Article 56a
The name of the medicinal product, as referred to in Article 54, point (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.
Article 57
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,
- authenticity and identification in accordance with Article 54a(5).
For medicinal products authorised under Regulation (EC) No 726/2004, Member States shall, when applying this Article, observe the detailed guidance referred to in Article 65 of this Directive.
Article 58
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.
Article 59
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:
1. 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;
2. 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:
1. contra-indications;
2. appropriate precautions for use;
3. 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;
4. special warnings;
d
the necessary and usual instructions for proper use, and in particular:
1. the dosage,
2. the method and, if necessary, route of administration;
3. 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:
1. the duration of treatment, where it should be limited;
2. the action to be taken in case of an overdose (such as symptoms, emergency procedures);
3. what to do when one or more doses have not been taken;
4. indication, if necessary, of the risk of withdrawal effects;
5. 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:
1. a warning against using the product after that date;
2. where appropriate, special storage precautions;
3. if necessary, a warning concerning certain visible signs of deterioration;
4. 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;
5. for each presentation of the product, the pharmaceutical form and content in weight, volume or units of dosage;
6. the name and address of the marketing authorisation holder and, where applicable, the name of his appointed representatives in the Member States;
7. the name and address of the manufacturer;
g
where the medicinal product is authorised in accordance with Articles 28 to 39 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.
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 standardised explanatory sentence.
For all medicinal products, a standardised text shall be included, expressly asking patients to communicate any suspected adverse reaction to his/her doctor, pharmacist, healthcare professional or directly to the national spontaneous reporting system referred to in Article 107a(1), and specifying the different ways of reporting available (electronic reporting, postal address and/or others) in compliance with the second subparagraph of Article 107a(1).
2
The list set out in point (c) of paragraph 1 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 pursuant to Article 65.
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.
4
By
1 January 2013
, the Commission shall present to the European Parliament and the Council an assessment report on current shortcomings in the summary of product characteristics and the package leaflet and how they could be improved in order to better meet the needs of patients and healthcare professionals. The Commission shall, if appropriate, and on the basis of the report, and consultation with appropriate stakeholders, present proposals in order to improve the readability, layout and content of these documents.
Article 60
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.
Article 61
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 authorities competent for authorising marketing when the marketing authorisation is requested. The results of assessments carried out in cooperation with target patient groups shall also be provided to the competent authority.
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 and the marketing authorization holder.
Article 62
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 to the patient, to the exclusion of any element of a promotional nature.
Article 63
1
The particulars for labelling listed in Articles 54, 59 and 62 shall appear in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.
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.
In the case of certain orphan medicinal products, the particulars listed in Article 54 may, on reasoned request, appear in only one of the official languages of the Community.
2
The package leaflet must be written and designed in such a way as to be clear and understandable, enabling users to act appropriately, when necessary with the help of health professionals. The package leaflet must be clearly legible in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.
The first subparagraph shall not prevent the package leaflet from being 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 competent authorities 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. They 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 the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.
Article 64
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.
Article 65
In consultation with the Member States and the parties concerned, the Commission shall draw up and publish detailed guidance concerning in particular:
1. the wording of certain special warnings for certain categories of medicinal products;
2. the particular information needs relating to non-prescription medicinal products;
3. the legibility of particulars on the labelling and package leaflet;
4. the methods for the identification and authentication of medicinal products;
5. the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated;
6. harmonised provisions for the implementation of Article 57.
Article 66
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 and address of the manufacturer,
- the amount of radioactivity as specified in paragraph 2.
Article 67
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.
Article 68
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.
Article 69
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); if the homeopathic 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,
- 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.
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.
Substituted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Inserted by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA relevance).
Substituted by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance).
Inserted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Inserted by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance).
Substituted by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA relevance).
Substituted by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (Text with EEA relevance).