Official Control Authority Batch Release (OCABR)
OCABR is based in Regulation (EU) 2019/6, article 128, which repeals article 82 of Directive 2001/82/EC, as amended. OCABR performed by any given member state must be recognised by all other member states requiring OCABR for that product.
The Official Control Authority Batch Release (OCABR) procedure has been currently applied for the following immunological veterinary medicinal products (IVMPs) in the Czech Republic:
- Swine Erysipelas Vaccine live
- Rabies Vaccine for Foxes and Raccoon Dogs live
- Rabies vaccine for veterinary use inactivated
- Equine Influenza Vaccine inactivated
- Tuberculin Purified Protein Derivative (PPD), Avian
- Tuberculin Purified Protein Derivative (PPD), Bovine
Official Batch Protocol Review (OBPR)
Paragraph 1 of Article 128 Reg (EU) 2019/6 (following the principles of former article 81 of Directive 2001/82/EC as amended) allows a member state to ask a Marketing Authorisation Holder (MAH) to provide documentation to a control authority or an OMCL proving that control tests were carried out in accordance with the methods laid down in the marketing authorisation (MA). This is referred to as an OBPR. A goodwill agreement has been adopted by the VBRN to mutually recognise OBPR certificates between member states provided the procedure and rules codified by the network are followed.
The Official Batch Protocol Review (OBPR) procedure has not been applied to any immunological veterinary medicinal products (IVMPs) in the Czech Republic.