Application of provisions of the Article 81 and Article 82 of the Directive 2001/82/EC as amended by the Directive 2004/28/EC has been established in the national Act 378/2007 Coll. concerning regulation of medicinal products.

At the present time the Official Batch Protocol Review (OBPR) procedure has been applied in the Czech Republic for Dermatophytosis vaccines live and inactivated.

The Official Control Authority Batch Release (OCABR) procedure has been currently applied in the Czech Republic for the following IVMPs:

• Swine Erysipelas Vaccine live 
• Rabies Vaccine for Foxes and Raccoon Dogs live 
• Equine Influenza Vaccine inactivated 
• Rabies vaccine for veterinary use inactivated 

Attachments:

Pokyn ÚSKVBL	[ ]	1420 Kb
žádost OBPR	[ ]	92 Kb
žádost OCABR	[ ]	93 Kb