Immunological veterinary medicinal products carry a control step that most other veterinary products do not. Under Article 128 of Regulation (EU) 2019/6, a Member State may require that samples of each batch be submitted to a competent authority for official testing before the batch is placed on the market. For vaccine manufacturers, this independent check sits on the critical path to supply, and it has to be planned rather than absorbed.
The legal basis
Official control authority batch release for immunological veterinary medicinal products is grounded in Article 128 of Regulation (EU) 2019/6, which replaced the corresponding provision of Directive 2001/82/EC when the regulation became applicable on 28 January 2022. Paragraphs 3 to 9 allow a Member State, for reasons of human or animal health, to require samples of each batch of a given product to be submitted for official testing by an Official Medicines Control Laboratory before marketing.
Two certificate types
- Official control authority batch release (OCABR). The laboratory performs experimental testing on the batch in addition to reviewing the manufacturer’s protocol.
- Official batch protocol review (OBPR). The laboratory reviews the manufacturer’s batch documentation without full independent testing.
Which applies depends on the product and the risk assessment made by the competent authority, guided by the European batch testing guidelines. The European Directorate for the Quality of Medicines and HealthCare coordinates the network and publishes the administrative procedure applying Article 128.
Mutual recognition
A significant efficiency sits in the recognition rule: batch release performed by one Member State must be recognised by all other Member States that require batch release for that product. A single release therefore serves the Union market rather than requiring parallel testing in each country of supply. Realising that benefit depends on selecting the release laboratory sensibly and on ensuring the certificate travels with the batch documentation to every market.
Planning implications
- Lead time. Testing takes time, and biological assays are not always quick. Build the release step into supply planning rather than treating it as a formality at the end.
- Sample and protocol quality. Incomplete or inconsistent batch protocols are a common cause of delay. The protocol should tell the reviewer the story of the batch without follow-up questions.
- Change control. Manufacturing changes can affect the testing arrangement. The laboratory should not learn about a process change from an unexpected result.
- Shelf life. Time spent in official release is time not spent on the market. For products with constrained shelf life, that is a commercial variable.
How PQRA helps
PQRA supports manufacturers of immunological veterinary medicinal products through the official batch release process: preparing and reviewing batch protocols, liaising with control laboratories and competent authorities, aligning release arrangements with supply planning, and ensuring certificates are used efficiently across the markets a batch serves. We also advise on quality system requirements for vaccine manufacture under the new veterinary GMP regulations.
For support with veterinary vaccine quality and release, contact PQRA.
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