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

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

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Article 54U.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)

[F1the 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 [F1detailed guidance] published pursuant to Article 65. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated;

(e)

[F1the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated;]

(f)

[F1a 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)

[F1specific 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)

[F1the 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)

[F1in the case of non-prescription medicinal products, instructions for use;]

(o)

[F2for 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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