Export Certification

Export Certificates can be issued for veterinary medicines and for Irish manufacturers of these. The can include:  

• batch certificates
• certificates of free sale for medicines
• certificates of manufacture and free sale
• certificates of pharmaceutical product
• certification of company documents;
• certified copies of manufacturing authorisations
• GMP certificates for both finished products and active substance
• statements of licensing status of pharmaceutical product

In general, these documents are only issued to the marketing authorisation holders or authorised manufacturers of medicines or active substances.

Where the applicant is not the holder of the marketing authorisation or manufacturing authorisation, a letter of authorisation from the holder must be provided.

Where possible, certificate formats, as published by the World Health Organisation, are used. Visit the WHO Certification Scheme webpage for further information on the types of certificates approved by the WHO in their guideline.