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

1. (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;

2. (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;

3. (c)

   the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;

4. (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;

5. (e)

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

6. (f)

   F1a special warning that the medicinal product must be stored out of the reach and sight of children;

7. (g)

   a special warning, if this is necessary for the medicinal product;

8. (h)

   the expiry date in clear terms (month/year);

9. (i)

   special storage precautions, if any;

10. (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;

11. (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;

12. (l)

    the number of the authorization for placing the medicinal product on the market;

13. (m)

    the manufacturer's batch number;

14. (n)

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

15. (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.