# Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Article 54

Extent: E+W+S+N.I.

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 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 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;
(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) 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) 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 authorization for placing the medicinal product on the market;
(m) the manufacturer's batch number;
(n) in the case of non-prescription medicinal products, instructions for use;
(o) 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.

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Source: https://www.legislation.gov.uk/eudr/2001/83/article/54 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/article-54
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.