E-drug: Concept of "manufacture" of medicinal products
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Dear e-druggers,
I am a PhD student working on parallel trade of medicinal products in
the European Union. I am currently looking for information on the
concept of "manufacture" of medicinal products and the interpretation
of Directive 91/356 and the relevant provisions of Directive 2001/83
and Regulation 2309/93. Since the legislation is not completely clear,
I have a number of questions to which I would really appreciate any
possible guidance:
a. Who is the "manufacturer" mentioned in the above Directives? Is it
the company which undertook the research and development of
the medicinal product or some other actor participating later? It is
clear that he may not be the holder of the marketing authorisation
but then how does he obtain the right to manufacture the
medicinal product?
b. When does he apply for the manufacturing authorisation? Before
or after the relevant marketing authorisation?
c. Is there a distinction between a centralised and a decentralised
authorisation procedure for the manufacturing of medicinal
products? Can we have a community-wide manufacturing
authorisation or is it a purely national one? In the latter case, to
what extent? I would really appreciate any possible help on
answering the above questions as soon as possible. I have
already searched all the relevant European websites (europa,
EMEA, EFPIA), so no need to send me links to those pages.
Regards,
Despina Samara
King's College, University of London
United Kingdom
Tel: 00447714437288
e-mail: despina.samara@kcl.ac.uk
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