Commented CodexPharma Public Health in Belgium Medicinal Products May 2009

Commented Codex-Pharma Public Health in Belgium (Medicinal Products)

Marc Martens & Nicolas Carbonnelle

pharma.be, May 2009 - May 2009.

pharma.be (AGIM) is a non-profit organisation founded in 1966 with the object of representing the interests of the medicines industry in Belgium. About 150 pharmaceutical compaies based in Belgium make up its membership. Its mission is to try and create a favourable economic climate in which research and development of new medicines is a priority. pharma.be is thus active at all three stages in the life of medicinal product: research (human experimentation and clinical trials); marketing of the medicine (public health); price and reimbursement (social and economic affairs).

The Commented Codex Pharma seeks to be a practical tool in the field of Belgian public health regulation (medicines) for its members and all the pharmaceutical sector players, namely the regulatory authorities, doctors, veterinary practitioners, pharmacists, wholesalers, hospitals and of course employees of the Federal Agency for Medicines and Health Products.

This Codex covers four specific fields that are regulated by four European Regulations that are applicable directly in the Belgian legal system.

- Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products,

- Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency,

- Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No. 726/2004,

- Regulation (EC) No. 1394/2007 of the European PArliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC end Regulation (EC) No. 726/2004.

In addition to a consolidated version of the European texts applicable directly in Belgium, this Codex contains a general commentary on each of these texts. After the Codex Pharma, a collection of the most pertinent regulatory texts in the field of public health (medicines), and the Codex Pharma Commenté/Becommentarieerde Codex Pharma, this work constitutes the third stage in the Codex Pharma collection.

The authors of this Commented Codex Pharmaare lawyers, who are all experts on the Belgian and European pharmaceutical sector.

The contribution to this Codex has been realized by Marc Martens and Nicolas Carbonnelle (Bird & Bird), Geneviève Michaux (Covington & Burling LLP), Thibaut D'hulst, Peter L'Ecluse, Catherine Longeval and Koen T'Syen (Van Bael & Bellis)

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