Regulation (EC) No. 726/2004
 Regulation (EC) No. 726/2004 |
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| Title: | Regulation (EC) No. 726/2004 of the European Parliament and of the Council of March 31, 2004 laying down community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency |
| Scope: | EEA |
| Legal matter: | Pharmaceutical law |
| Basis: | Art. 95 |
| Procedure overview: |
European Commission European Parliament IPEX Wiki |
| To be used from: | May 20, 2004 |
| Reference: | OJ L 136 of April 30, 2004, pp. 1-33 |
| Full text |
Consolidated version (not official) basic version |
| Regulation has entered into force and is applicable. | |
| Please note the information on the current version of legal acts of the European Union ! | |
The Regulation (EC) no. 726/2004 is a regulation of the European Union in which the Community mechanism for centralized authorization and supervision of medicinal products is regulated in the European Union. The regulation is also the legal basis for the establishment and operation of the European Medicines Agency . Since the vast majority of innovative medicinal products are now authorized via the centralized procedure, this regulation is of great importance for European pharmaceutical law. As an EC regulation of the European Parliament and the Council , it is directly binding in all member states of the European Union .
structure
The regulation is divided into five titles. Title I contains definitions, Titles II and III deal with the authorization and monitoring of medicinal products for human and veterinary use by the European Medicines Agency and the European Commission, Title IV regulates the competence and administrative structure of the European Medicines Agency and Title V contains final provisions. Finally, the regulation also contains an annex that explicitly states the types of medicinal products that must be authorized through the centralized procedure; These include, among other things, biotechnologically manufactured drugs and drugs with new drugs that are used for certain diseases, such as cancer or AIDS . This regulation also stipulates that certain information on a drug approval must then be published in an assessment report ( European Public Assessment Report EPAR ).
history
Regulation (EC) No. 726/2004 replaces Regulation (EEC) No. 2309/93 of 1993, in which, with effect from 1995, the centralized procedure for drug approval and the establishment of the European Medicines Agency were laid down for the first time. As part of the new regulation, the applicability of the centralized approval procedure has been significantly expanded, the pharmacovigilance procedures have been revised and the basis has been created for increased transparency in the agency's work.
The regulation came into force in May 2004; Notwithstanding this, Titles I to III and V did not apply until November 20, 2005. Since it came into force, the regulation has been amended four times, on the one hand by the regulation on medicinal products for children ( Regulation (EC) No. 1901/2006 ), and on the other hand by the regulation on medicinal products for advanced therapies ( Regulation (EC) No. 1394/2007 ) , and twice by regulations amending Regulation (EC) No. 726/2004 ( Regulation (EU) No. 1235/2010 of the European Parliament and of the Council of December 15, 2010 and Regulation (EU) No. 1027/2012 of the European Parliament and Council of 25 October 2012).
