Batch release certificates, Export certificates ("Certificate of a Pharmaceutical Product") and GMP certificates can be requested from the MEB Agency, Veterinary Medicinal Products Unit.
Batch release certificate
By providing a batch release certificate, the government wants to prevent immunological veterinary medicinal products that could pose a risk to humans, animals or the environment from being marketed.
The marketing authorisation holder of an immunological veterinary medicinal product submits a copy of the monitoring report – consisting of the batch protocol and the batch release document signed by the authorised individual – to the Veterinary Medicinal Products Unit.
Following receipt of the monitoring report, the Veterinary Medicinal Products Unit performs an administrative check. If the veterinary medicinal product meets the requirements of the marketing authorisation, then a batch release certificate is issued.
Batch release certificate application
If you are a marketing authorisation holder of an immunological veterinary medicinal product, you can apply for a batch release certificate. To process an application in an efficient manner, you are requested to fill in the batch release request form truthfully.
As an appendix to the form, please provide:
- A copy of the monitoring report of the relevant batch, consisting of the batch protocol and the batch release document signed by the authorised person.
- If applicable, a copy should also be provided of the batch release certificate already issued by another member state – in accordance with Article 81 or 82 of Directive 2001/82/EC.
These documents can be attached with the application in PDF format.
Please visit the EDQM website for a further description of the procedure and the required documents (including sample batch protocol templates).
When the application is complete, the request will be processed by the Veterinary Medicinal Products Unit. A confirmation of receipt will be sent. If the application is not complete, the Veterinary Medicinal Products Unit will contact you for additional information.
An administrative check will be carried out based all information submitted. If the immunological veterinary medicinal product is in accordance with the marketing authorisation, a batch release certificate will be issued.
Export certificate (CPP)
An export certificate for a veterinary medicinal product, defined as a “Certificate of a Pharmaceutical Product” (hereafter CPP) is issued at the request of:
- the marketing authorisation holder for a veterinary medicinal product in the Netherlands, or the manufacturer or exporter of said product;
- a Dutch manufacturer or exporter of a veterinary medicinal product for which a marketing authorisation has not been issued for the Netherlands and which is intended solely for exportation outside the EEA.
Contrary to what the name suggests, a CPP can also be requested for an immunological veterinary medicinal product.
The Dutch government uses a CPP to inform the authority of the importing country:
- whether a marketing authorisation has been issued in the Netherlands for the veterinary medicinal product;
- whether the manufacturer in question has the required authorisations and produces according to the GMP guidelines (Good Manufacturing Practices).
As of 8 September 2014, a CPP will exclusively be drafted according to the World Health Organization guidelines.
For the application for an export certificate to be processed efficiently, please:
- complete the application form truthfully and follow the relevant instructions
- send the completed application form (MS Word version) separately per application by e-mail to the MEB Agency, Veterinary Medicinal Products Unit, email@example.com. Annexes can be sent with the application in PDF format.
If the application is complete, it will be processed by the MEB Agency, Veterinary Medicinal Products Unit and you will receive confirmation of receipt.
If the application is not complete, the MEB Agency, Veterinary Medicinal Products Unit will contact you by telephone or by e-mail, requesting additional information in order to complete the application.
The application will be processed within 6 weeks.
A Certificate of GMP compliance of a manufacturer (hereafter: GMP certificate) is issued to a manufacturer or importer of veterinary medicinal products within 90 days following a successful GMP inspection.
GMP certificates that are issued to manufacturers of (veterinary) medicinal products in the EU are also listed in the EudraGMDP database. This database includes information about GMP certificates of all manufacturers and importers of medicinal products for humans and animals in the EEA and other manufacturers outside the EEA that have been inspected by European authorities.
The aim of a GMP certificate is to indicate:
- which production location, activities and administration forms of a manufacturer – following GMP inspection – are found to meet the guidelines for Good manufacturing practices for veterinary medicinal products (GMP) in accordance with directive 91/412/EC.
- when the last GMP inspection took place. European legislation stipulates that the next GMP inspection must be performed within 3 years of the previous inspection.
If a copy is required of a previously issued GMP certificate, please complete the application form for a (copy of) GMP certificate.