Biomedical Engineering Reference
In-Depth Information
Table 4.11
The nine-volume series that comprises 'The Rules Governing Medicinal Products in the
European Union'
Volume 1 - Pharmaceutical Legislation
Medicinal products for human use
Volume 2 - Notice to Applicants
Medicinal products for human use
Volume 3 - Guidelines
Medicinal products for human use
Volume 4 - Good Manufacturing Practices
Medicinal products for human and veterinary use
Volume 5 - Pharmaceutical Legislation
Veterinary medicinal products
Volume 6 - Notice to Applicants
Veterinary medicinal products
Volume 7 - Guidelines
Veterinary medicinal products
Volume 8 - Maximum Residue Limits
Veterinary medicinal products
Volume 9 - Pharmacovigilance
Medicinal products for human and veterinary use
was formed by an EU regulation and three directives. Central to this was the establishment of
a European agency for the evaluation of medicinal products, the European Medicines Agency
(EMEA), which is based in London and began work in January 1995. Two new marketing authori-
zation (drug registration) procedures for human or veterinary drugs are now in place within the
EU:
•
a centralized procedure in which applications for a marketing licence are forwarded directly to
the EMEA;
•
a decentralized procedure based upon mutual acceptance or recognition of national authority
decisions; disputes arising from this system are arbitrated by the EMEA.
The EMEA is comprised of:
•
A management board, consisting of representatives of each EU member state and representa-
tives of the European Commission and European Parliament. This group functions mainly to
coordinate EMEA activities and manage its budget.
•
Pre-authorization evaluation of medicines for human use unit. This unit provides scientifi c ad-
vice relating to quality, safety and effi cacy issues, as well as relating to orphan drugs.
•
Post-authorization evaluation of medicines for human use. This regulatory affairs unit is re-
sponsible for issues such as post-marketing surveillance of drugs.
•
Veterinary medicines and inspections. This unit is responsible for veterinary marketing authori-
zation procedures and inspections.
Central to the functioning of the EMEA are three committees:
•
The Committee for Medicinal Products for Human use (CHMP). This committee is composed
of 35 technical experts drawn from the various EU member countries. It is primarily responsible
for formulating the EMEA's opinion on any medicinal product being considered for marketing
approval under the centralized procedure.
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