2022/406/B
EC/EFTA
BE Belgium
  • C00P - PHARMACEUTICALS AND COSMETICS
2022-09-12
2022-06-17

This draft concerns the distribution of unauthorised experimental and auxiliary medicinal products.

Draft Royal Decree amending various health decrees

The draft regulates the distribution of unauthorised experimental and auxiliary medicinal products.

Distribution shall be subject to the authorisation referred to in Article 12b of the Law of 25 March 1964 on medicinal products = WDA within the meaning of Directive 2001/83/EC (except for the manufacturer), and compliance with the good distribution practices set out in Annex V of the Royal Decree of 14 December 2006 on medicinal products for human use = GDP within the meaning of Directive 2001/83/EC.

The supply of unauthorised experimental and auxiliary medicinal products shall be limited to other holders of a manufacturing or import authorisation, to the other wholesale distributors referred to in Article 12b of the Law of 25 March 1964 on medicinal products, to hospital pharmacies or pharmacies open to the public, or to the investigators referred to in Article 2, § 2(15) of the Regulation.