|
|
|
|
|
|
|
|
|
|
How to use this compendium |
|
|
|
|
|
|
Explanation concerning the structure of the registration number of human and veterinary medicinal products in the centralised procedure |
|
|
|
Brandnames of medicinal products |
|
|
|
Brandnames of European registrations (general list of medicinal products for human and veterinary use) |
|
|
|
Brandnames of medicinal products for human use |
|
|
|
Brandnames of medicinal products for veterinary use |
|
|
|
|
|
|
Active substances for human use |
|
|
|
Active substances for veterinary use |
|
|
|
Marketing Authorisation Holders |
|
|
|
Marketing Authorisation Holders and their products (medicinal products for human use) |
|
|
|
Marketing Authorisation Holders and their products (medicinal products for veterinary use) |
|
|
|
Chronological lists of registrations |
|
|
|
Chronological list of registrations (medicinal products for human use) |
|
|
|
Chronological list of registrations (medicinal products for veterinary use) |
|
|
|
User package leaflets (medicinal products for human use) |
|
|
|
Summaries of Products Characteristics (SPC) (medicinal products for human use) |
|
|
|
Scientific discussion (medicinal products for human use) |
|
|
|
User package leaflets (medicinal products for veterinary use) |
|
|
|
Summaries of Product Characteristics (SPC) (medicinal products for veterinary use) |
|
|
|
Scientific discussion (medicinal products for veterinary use) |
|
|
|
Legislative background of the Community registration system for medicinal products |
|
|
|
Council Regulation (EEC) No. 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, OJ No. L 214 of 24. 8. 1993, 1-21 |
|
|
|
Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products, OJ No. L 214 of 24. 8. 1993, 22-30 |
|
|
|
Council Directive 93/40/EEC of 14 June 1993 amending Directives 81/851/EEC, 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products, OJ No. L 214 of 24. 8. 1993, 31-39 |
|
|
|
Council Directive 93/41/EEC of 14 June 1993 repealing Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology, OJ No. L 214 of 24. 8. 1993, 40 |
|
|
|
Commission Regulation (EC) Nr. 1662/1995 of 7 July 1995 laying down certain detailed arrangements for implementing the Community decision-making procedure in respect of marketing authorisations for products of human and veterinary use/OJ No. L 158 of 8. 7. 1995 |
|
|
|
Commission Regulation (EC) No. 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation granted by the competent authority of a Member State, OJ No. L 55 of 11. 3. 1995, 7-14 |
|
|
|
Commission Regulation (EC) No. 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation falling within the scope of Council Regulation (EEC) No. 2309/93, OJ No. L 55 of 11. 3. 1995, 15-21 |
|
|
|
Commission Regulation (EC) No. 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorisation for a medicinal product falling within th escope of Council Regulation (EC) No. 2309/93. OJ No. L 286 of 8. 11. 1996 |
|
|
|
Commission Regulation (EC) No. 297/95 on the fees payable to the European Medicines Evaluation Agency (EMEA) No. 297 of 10.2.1995, OJ No. L 35 of 15. 2. 1995 |
|
|
|
European registration authorities |
|
|
|
The European Agency for the Evaluation of Medicinal Products (EMEA) |
|
|
|
Members of the Committee for Proprietary Medicinal Products (CPMP) |
|
|
|
Members of the Committee for Veterinary Medicinal Products (CVMP) |
|
|
|
Addresses of the national authorities for delivery of the dossier and subsequent correspondence for the authorisation of medicinal products for human use |
|
|
|
Addresses of the national authorities for pharmacovigilance, reporting of defects and inspection of medicinal products for human use |
|
|
|
Addresses of Poisons Information Centres in the Member States |
|
|
Shopping Cart
