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.
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).