Directive 2001/83/EC of the European Parliament and of the CouncilShow full title

Article 54 U.K.

The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:

(a)

[F1 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 [F1 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)

[F1 the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated;]

(f)

[F1 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)

[F1 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)

[F1 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)

[F1 in the case of non-prescription medicinal products, instructions for use;]

(o)

[F2 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.]

Textual Amendments

F1 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.

F2 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).