E-DRUG: EMEA and "WHO procedure" in new EU drug legislation
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[from http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2003/oct/AISAAAD.pdf,
where you can get all 100 pages of the new EU drug legislation; WB]
Dear E-druggers,
Apparently from 1st May 2004, new EU drug legislation allows for drugs to be
evaluated by EMEA, that are intended exclusively for markets *outside* the
EU.
Article 58 (reproduced below) is already nicknamed the "WHO procedure".
Would this section be helpful in evaluating NCEs or old Chemical Entities
for the use in neglected diseases in developing countries?
And would EMEA be able to evaluate (and "approve") drugs prequalified by
WHO??
Anyone already seen the procedures for this article?
"Article 58
1. The Agency may give a scientific opinion, in the context of cooperation
with the World Health
Organisation, for the evaluation of certain medicinal products for human use
intended exclusively
for markets outside the Community. For this purpose, an application shall be
submitted to the
Agency in accordance with the provisions of Article 6. The Committee for
Medicinal Products for
Human Use may, after consulting the World Health Organisation, draw up a
scientific opinion in
accordance with Articles 6 to 9. The provisions of Article 10 shall not
apply.
2. The said Committee shall establish specific procedural rules for the
implementation of
paragraph 1, as well as for the provision of scientific advice.
"
Your comments are welcome!
Wilbert Bannenberg
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Dr Wilbert Bannenberg, coordinator Neglected Diseases Group, MSF
Mobile +31-6-20873123
Tel home office +31-497-550713
Fax +31-497-550712
Email: wjb@wxs.nl
**please note: wilbertbannenberg@compuserve.com no longer valid**
Postal address:
Prins Bernhardstraat 1, 5571 GC Bergeyk, The Netherlands
Work website: www.accessmed-msf.org/ndg
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