European Union Regulations and Guidance Documents


EudraLex: Rules Governing Medicinal Products in the European Union. URL: htm. The European Union Drug Regulatory Authorities (EUDRA) web site contains a wealth of practical information assembled in a collection entitled EudraLex. The table of contents found at this URL includes nine "volumes'' hyperlinked to documents containing draft and final legislation and guidelines. Rules governing good manufacturing practices, maximum residue limits, and pharmacovigilance are presented in separately labeled sections.

European Medicines Evaluation Agency (EMEA). URL:http:// Cited previously as a source for the Community Register of Medicinal Products, EPARs, and CHMP Opinions, the EMEA Web site is a repository for many other useful regulatory documents, such as EU Public Safety Reports and withdrawals or suspensions of products previously authorized under the Centralized Procedure. A comprehensive list of EU Guidance documents is accessible at this site through a subject index. Individual Guidance titles link directly to full-text documents in PDF format. Another quality-control-related section of EMEA's Web site is dedicated to the policies and procedures of regulatory inspections. This information is augmented with a useful hyperlinked directory to inspection authorities worldwide, subdivided by countries and regions.

The Regulatory Affairs Journal—Europe (RAJ Europe). Richmond, Surrey, U.K.: PJB Publications. Annual, updated monthly. RAJ Europe is not a journal in the traditional sense, but, rather, a systematically updated archive of rules, regulations, and guidelines governing medical product marketing in the European Union. Issued on CD/ROM, the database compiles regulatory documents related to the development, production, registration, and sale of human-use pharmaceuticals, veterinary medical products, and medical devices. It includes CHMP reports and opinions and EMEA guidelines, as well as relevant extracts from the Official Journal of the European Communities.

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