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On 4 September, 5 Members of the EU Parliament published a written
declaration. In their document, the 5 Members of Parliament explain that
the certification of Good Manufacturing Practice (GMP) ensures an improved
quality of active pharmaceutical ingredients. They mention that the
different manufacturers in the EU do not receive a GMP certificate until
their sites have been successfully inspected by a GMP inspectorate from an
EU member state, whereas manufacturers in third countries are not
inspected. The Members of Parliament consider this practice as a risk to
the patients' health.
Therefore, the declaration calls for inspections of all manufacturers
of active pharmaceutical ingredients by EU authorities in order to obtain
a GMP certificate - no matter if the manufacturing sites are located
within or outside the Community. Besides, the group proposes the
introduction of traceability of the active ingredients. This should be
reached by discouraging the relabelling of active ingredients.
Till 4 December 2006, comments are compiled and evaluated. If the
requirements proposed in the declaration are implemented, the consequences
will be far-reaching. The present regulation requiring the manufacturer
of the medicinal product to verify the GMP compliance of an active ingredient (usually
by means of an audit) will be enhanced by supervision on the part of the
authorities.
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