The following information was published on the EMEA website on 24 March
"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".