batch inspections and declarations
Batch inspections (batch control)
to Articles 40 to 42 of the Veterinary Medical Products
Regulations, the government should test the quality of batches of
immunobiological veterinary medicinal products with both
administrative and experimental batch inspections before they are
The government uses the batch inspection to prevent the marketing
of vaccines posing a potential risk for humans or animals. A
distinction can be made here between batch inspections on the
national or European level.
The Veterinary Medicinal Products Unit issues the following
- Veterinary Medicine Certificate, hereafter referred to as the
Free Sale Certificate, or
- Certificate of a pharmaceutical product (WHO certificate);
- Statement of a manufacturer (GMP certificates).
In accordance with Art. 75 of the Veterinary Medical Products
Regulations, the minister can certify upon request of:
- the holder of a permit for the preparation, packaging,
labelling or delivery of veterinary medicinal products
- the authorised agency of the country into which the veterinary
medicine has been imported; a declaration for the export of a
veterinary medicine that confirms that the manufacturer in question
has a permit for the preparation, packaging, or labelling and
delivery of veterinary medicinal products.
Authorities in the member states should inform each other about
the GMP status of pharmaceutical companies with a production
permit. This applies also to questions from countries with which
the EU has concluded a Mutual Recognition Agreement (Australia,
Canada, New Zealand and Switzerland).
A GMP certificate is intended to indicate:
- the production process and forms of administration in which the
manufacturer meets the criteria of the good practice guidelines
concerning the preparation of medicinal products for veterinary use
(GMP) in accordance with Directive 91/412/EG.
- when the last GMP inspection was performed. European
legislation requires a new GMP inspection to be performed every 2
years (or at most 3 years) after the last inspection.
This certificate is issued to the holder of a permit for the
preparation (including import), packaging or labelling, after
inspection has shown that the GMP level is considered adequate.