The Regulatory System in Europe with Special Emphasis on Allergen Products

A.R. Lorenz, D. Lüttkopf, R. Seitz, S. Vieths Division of Allergology, Paul-Ehrlich-Institut, Langen, Germany Address of Corresponding Author Abstract For each medicinal product quality, safety and efficacy have to be proven to obtain a marketing authorisation. The national competent health authorities and the European Medicines Agency (EMEA) with support of the Heads of Medicines Agencies (HMA) work together to grant marketing authorisations for medicinal products. Several regulatory procedures to apply for a marketing authorisation in the European Community (EC) and associated countries exist. After approval by a national procedure a medicinal product can be marketed in only one country. If a medicinal product should enter the markets of two or more European countries of choice the application has to undergo the Mutual... [read full story]