On May 16, 2006 the Belgian Official Journal published a new act, structurally reforming the Belgian pharmaceutical legislation: "Loi du 1er mai 2006 portant révision de la législation pharmaceutique / Wet van 1 mei 2006 houdende herziening van de farmaceutische wetgeving."
The principal modifications are:
- Implementation of European legislation:
I. Implementation of three European directives:
1) Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
2) Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products
3) Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use
II. It also takes into consideration the following regulation:
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
III. Among others, as a consequence:
1) Reduction of the tasks of the national authority (e.g. suppression of the five-year marketing authorization or the possibility for a generic medicinal product to refer to a medicinal product authorized in another EU country).
2) New dispositions (e.g. obligation to mention the name of the medicinal products in Braille on the labelling; transparency of the evaluation of the medicinal products to the public (except confidential data); the active substance used in the fabrication of medicinal products will be under GMP control; possibility to select directly several countries for the authorization of a medicinal product (one of them evaluating the request) without awaiting the approval by one country).
3) New databases managed by the EMEA (e.g.: pharmacovigilance, GMP certificate, ...).
- Medicine Act of 25 March 1964:
1) This act implements the abovementioned directives as well as the Directive 2001/83/EC on the Community code relating to medicinal products for human use and the Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
2) New Committee advises in case of doubt whether the pharmaceutical legislation applies or not to a product.
3) OTC medicinal products can be sold at distance (among others on internet), not the medicinal products under prescription.
4) Possibility for the government to inform the public on the rational use of medicinal products.
5) Veterinarians may buy medicinal products to pharmacists as well as directly to wholesalers (there are nonetheless some exceptions).
6) Possibility for the veterinarians and the pharmacists to fraction conditioning of veterinary medicinal products.
7) Possibility to prescribe unauthorized medicinal products (1) for compassionate use (see EC Regulation n° 726/204) and (2) in case of medical emergency.
- Pre-mixes for medicated feedingstuffs:
Inclusion of pre-mixes for medicated feedingstuffs into the pharmaceutical legislation.
- veterinary medicinal products:
Harmonization of the regime of sanctions.
