24 March 2006
EMEA:
GMP Information for QP Compliance with the requirements
of the Marketing Authorisation
A batch of medicinal product that does not comply with the requirements
of the marketing authorisation cannot lawfully be released for sale.
From time to time a Qualified Person (QP) can be faced with a batch of
product that does not fully comply with all the details described in the
authorised marketing authorisation dossier. The competent authorities
have been considering whether or not a QP is able to certify such
batches, as required in Art. 55(3)/51(3) of Directive 2001/82(3)/EC,
thereby allowing them to be released for sale. A reflection paper is
hereby published, which is intended to clarify, in the circumstances
described, whether a batch complies with the requirements of the
marketing authorisation or not. The paper describes certain conditions
that must be met. It is hoped that this paper will be helpful in dealing
with a large proportion of cases where there has been some uncertainty
in the past. Cases of non-compliance outside the scope of this paper
must continue to be dealt with by following the relevant national
procedures.
The European Commission has signalled its possible future support for a
corresponding amendment to Annex 16 of the GMP Guide (Certification by a
Qualified Person and Batch Release). This will partly depend on feedback
from the industry on the practical implementation of the details in this
reflection paper. EMEA is presently considering, together with the
Commission, how this feedback should be collected and further
information on this will be provided in the coming months.
Read the
reflection paper for further information.
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