1) a centralized procedure to obtain authorization to market pharmaceutical products, principally technologically advanced medicinal products, especially those derived from biotechnology. This procedure, which is set forth mainly in Regulation 2309/93, provides essentially that the marketing of products falling within the aforementioned category must be authorized under the centralized procedure. In addition, products falling within the criteria defined in Part B of the Annex to Regulation 2309/93 (i.e., other biotechnology and innovatory products) may be accepted for consideration under the centralized procedure. Regulation 2309/93 establishes the EMEA for the purpose of granting authorizations, valid throughout the EU, in reliance on opinions from the Committee for Proprietary Medicinal Products; and

2) a decentralized procedure to obtain authorization to market medicinal products in the EU which are not the subject of the centralized procedure. This procedure is set out mainly in EU Directive 93/39, and is based on the multistate procedure in existence when this directive was adopted. The underlying principle for this procedure is that an authorization to place a medicinal product on the market in one member state ought to be recognized by the competent authorities of the other member states. This procedure applied with effect from January 1, 1995; however, after January 1, 1998, it will not be possible for a member state to carry out an independent national assessment of a relevant product, if another member state has already granted a marketing authorization for that product.