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The European Medicines Agency EMEA and EU Commission's DG Enterprise and
Industry Directorate have developed a document which describes the issue and
update of GMP Certificates. The paper is part of the Compilation of
Community Procedures on Inspections and Exchange of Information.
Directive 2001/83/EG amended by Directive 2004/27/EG requires that "within
90 days of an inspection … a certificate of good manufacturing practice
shall be issued to a manufacturer if the outcome of the inspection shows
that the manufacturer complies with the principles and guidelines of good
manufacturing practice as provided for by Community legislation" (article
111 §5).
The document is intended to give interpretation on aspects of
responsibilities of the issue, renewal and update of GMP certificates. The
issue of GMP certificates following an inspection of a manufacturer of IMPs
is not defined, however Member States may choose to do so. In any case an
entry in the EudraGMP database should be made whether or not a certificate
is issued to the manufacturer in question.
Date of coming into operation is 30 September 2007.
The full document can be found on EMEA's
website.
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