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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.