batch inspections and declarations

Batch inspections (batch control)
According 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 marketed.

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.

Declarations
The Veterinary Medicinal Products Unit issues the following declarations.

1. Veterinary Medicine Certificate, hereafter referred to as the Free Sale Certificate, or
2. Certificate of a pharmaceutical product (WHO certificate);
3. 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 or;
• 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.