Administrative batch release of vaccines and medicinal products derived from human blood or plasma

In the guideline MP/122, the State Institute for Drug Control instructs the marketing authorization holder (MAH) of medicinal products mentioned above about the requirements for submission of applications for approval of their release on Slovak market. Beside others, these requirements include delivery of EU Official Control Authority Batch Release Certificate and delivery of completed MIF for each production batch. Any batch of vaccines and blood products for human use cannot be placed on Slovak market without approval of the State Institute for Drug Control.

This guideline also covers requirements for parallel imported medicinal products.

Approval of releasing product groups as toxins, serums, allergens, whole blood, plasma and blood cells is not subject of this guideline.

Upon the request of the State Institute for Drug Control, MAH submits also the batch sample.

The permission to release Vaccines and medicinal products derived from human blood and plasma on the market in Slovak Republic issued by SIDC is based on OCABR administrative procedure

Source: The quality of these medicinal products has to be in compliance with the requirements of EU guidelines: https://www.edqm.eu/en/Human-OCABR-Guidelines-1530.html

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