In conformance with the Immunological Medicinal Products
Decree, Article5.1.e, certain unregistered
immunological medicinal products (IMP) can only be supplied if they
are released in lots by the Chief Inspector of Pharmacy and Medical
Technology from the Dutch Health Care Inspectorate. On their
behalf, the RIVM is responsible for administration and execution of
the procedure. For further information on the subject, please refer
to the document containing more background information. Every application
for batch release should be accompanied by a completed application
form (annex 1 (64Kb)) and supplementary list of
questions ( Annex 2 (88Kb)). For batch release, data are needed on the
chemical-pharmaceutical composition, preclinical studies and
quality control results of the relevant lot(s). The emphasis is put
on assessing the safety of the lot for which batch release is
requested. Disclaimer: No rights can be obtained from any of the
information presented here. The RIVM has the right to change the
documentation without any prior notice. Please verify that you
employ the most recent version(s). |