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
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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:
[F1(a) medicinal products on medical prescription for renewable or non-renewable delivery;]
(b)medicinal products subject to special medical prescription;
[F1(c) medicinal products on ‘ restricted ’ medical prescription, reserved for use in certain specialised areas.]
Textual Amendments
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