The EU/EEA Network for Official Control Authority Batch Release of Biologicals for Human Use
The control of medicinal products in the EU/EEA has two main goals: the protection of public health and the free movement of products. Specifications for medicinal products are defined in the product’s marketing authorisation dossier and should comply with the monographs of the European Pharmacopoeia. However, due to the inherent variability either in the production process or in their nature, biological medicinal products (vaccines and human blood and plasma derivatives) may require special attention prior to release on the market on a batch to batch level. This paper discusses post-licensing regulatory controls that can be applied to batches of these types of products in the EU/EEA.
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