TITLE VICLASSIFICATION OF MEDICINAL PRODUCTS

Article 70

1

When a marketing authorization is granted, the competent authorities shall specify the classification of the medicinal product into:

  • a medicinal product subject to medical prescription,

  • a medicinal product not subject to medical prescription.

To this end, the criteria laid down in Article 71(1) shall apply.

2

The competent authorities may fix sub-categories for medicinal products which are available on medical prescription only. In that case, they shall refer to the following classification:

F1a

medicinal products on medical prescription for renewable or non-renewable delivery;

b

medicinal products subject to special medical prescription;

F1c

medicinal products on restricted medical prescription, reserved for use in certain specialised areas.