Module 9 2024

03/09/2024

Official/National Vaccine Release

● Many countries now require lot release of vaccines

– (last survey in 2014 = 60 countries increasing from ~20 in 2006)

● But application varies…

● laboratory testing vs. paper release

● every lot vs. periodic testing

● Often requires batch summary information for each lot; transfer of laboratory assays; provision of biological standards/assay standards

The Organisation for Professionals in Regulatory Affairs

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Official Vaccine Release - Europe

● In the EU (in 1994) a network of official medicines control laboratories (OMCLs) was created

● Article 114 of Directive 2001/83/EC relating to medicinal products for human use, as amended by Directive 2004/27/EC, of the European Parliament and of the Council provides that ● a Member State laboratory may, but is not required to, test a batch of an immunological medicinal product or a medicinal product derived from human blood or plasma before it is placed on the market.

● Includes vaccines

● OMCLs support regulatory authorities in controlling the quality of medicinal products for human and veterinary use available on the market ● Batch Release performed by any given Member State must be mutually recognised by all other member states requiring official batch release for that product – key principle

OMCL - Background and mission - European Directorate for the Quality of Medicines & HealthCare (edqm.eu) (accessed Apr 2023)

The Organisation for Professionals in Regulatory Affairs

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