S.L. 458.34 Art. 26Classification of medicinal products.

(1) When a marketing authorisation is granted, the

Authority shall specify the classification of the medicinal product into:

(a) a medicinal product subject to medical prescription,

(b) a medicinal product not subject to medical prescription.

To this end, the criteria laid down in regulation 27(1) shall apply.

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

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

(b) medicinal products subject to special medical prescription;

(c) medicinal products on ''restricted'' medical prescription, reserved for use in certain specialised areas: Provided that where the Authority does not designate medicinal products into sub-categories, it shall nevertheless take into account the criteria referred to in regulation 27(2) and (3) in determining whether any medicinal product shall be classified as a prescription-only medicine.