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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

article  70

CELEX:  02001L0083-20250101

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:
(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.