The Approval system

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Whole section needs to be reviewed and updated.]]

The centralised procedure

An approval for a medicinal product intended for use in all EU countries may be obtained by applying to the EMEA (European Agency for the Evaluation of Medicinal Products) in London. Within the EMEA two scientific committees have been established, CHMP and CVMP (Committee for Proprietary Medicinal Products and Committee for Veterinary Medicinal Products). These committees prepare an opinion preceeding the formal the approval by the Commission. The member states have two representatives in each committee. The investigative work of the application is done by any of the EU countries. When EMEA has received a centralised application the responsible committee appoints a rapporteur/co-rapporteur. On the basis of the opinion from the scientific committees the Commission (or the Council) issues the formal decision to authorise a product in the centralised procedure. The Commission is assisted in the decision-making procedure by a Standing Committee whith representatives from each Member State.

Mutual recognition

Mutual recognition means that EU countries may approve the decision made about a medicinal product by another EU country. The pharmaceutical company submits their application to the country chosen to carry out the investigative work, which then approves or rejects the application. The other countries have to decide within 90 days whether they approve or reject the decision made by the original country. If the countries cannot agree, the EMEA and the CHMP/CVMP are responsible for making the decision. The formal decision is taken by the Commission.

The national procedure

Until 1998, the pharmaceutical industry could apply for a national approval. The product can then only be sold in that particular EU country. A marketing authorisation (MA) is valid for five years and the MA must be renewed every five years. In order to obtain an approval the product must be submitted with an SPC (Summary of Products Characteristics) which is the basis for the marketing of the product. For some products, i.e. generic products, it will be possible to use the national procedure also after 1998.