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In order to fulfil these requirements the Member States have now agreed
– after discussion at EMEA's ad hoc GMP inspection Services group - that
"(…) Annex 18 will no longer be considered as annex, but it will
form a new, Part II of the EU GMP (…)" (4). With this
restructuring the EU GMP Guide will now be presented in 2 Parts:
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Part I dealing with finished products
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Part II dealing with active substances used as starting materials
(applicable for medicinal products for both human and veterinary
use)
As the current Annex 18 is foreseen to become Basic Requirements Part
II of the EG GMP Guide, a Draft revision of the introductory section of
the current GMP annex 18 has been published (5). While Annex 18 in its
current version is applicable to the manufacture of APIs for use in human
drug (medicinal) only, the foreseen Part II of the EU GMP guide will
"(…) apply to the manufacture of active substances for
medicinal products for both human and veterinary use with the
exception of ectoparaciticides (…)" (see 1.2 Scope of the
revised introductory section of the current GMP annex 18, (5)).
Furthermore it will be necessary to amend some of the remaining annexes
to the EU GMP Guide "(…) to ensure they provide appropriate
supplementary guidance to the new Part II and to deal with any gaps and
overlaps. At the same time the opportunity will be taken to update the
annexes in the light of scientific and technical progress. (…)"
(4). For this reason, the Concept Paper written by the Ad Hoc GMP Inspection Services
Group lists changes to Annex 2 (Biologics), Annex 3 (Radioactive Drugs),
and Annex 6 (Medical Gas), which have to be updated. Besides, Annex 2 and
6 as well as Annex 7 (Herbal Medicinal Products) have overlaps that should
be corrected.
Comments on the Concept Paper can be handed in until 31 August 2005 (4).
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