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The EU pharmaceutical legislation refers directly to the Ph. Eur. and to other activities for which the EDQM is responsible (e.g. the Certification procedure or "CEP" and the OMCL Network – see below), demonstrating the shared commitment of the European organisations to public health protection.
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis
Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) ... Eudralex,The Rules Governing Medicinal Products in the European Union ...
This is the file index.xml in the submission sequence number folder. For example: ctd-123456/0000/index.xml The purpose of this file is twofold: Manage meta-data for the entire submission; Constitute a comprehensive table of contents and provide corresponding navigation aid.
To take into account the cross-border and global dimension of medicines markets, OMCLs co-operate actively at the European level and beyond. They do so through the General European OMCL Network (GEON), which was set up jointly by the Council of Europe and the European Commission (EC) in 1995. A number of non-European OMCLs have joined the ...
However, in the European Union, after one renewal, the marketing authorisation shall remain valid for an unlimited period, unless the competent regulatory authority decides otherwise. [ 3 ] If the marketing authorisation is not renewed in due time as requested by the local legislation, in order to maintain the pharmaceutical product on a market ...
The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. [8]
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.