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Internationally Harmonised Requirements for Batch Certification

Explanatory Note

In the framework of Mutual Recognition Agreements, the Sectoral Annex on Good Manufacturing Practices (GMP) requires a batch certification scheme for drug/medicinal products covered by the pharmaceutical Annex. The internationally harmonised requirements for the content of the batch certificate of a drug/medicinal product is attached. The importer of the batch is to receive and maintain the batch certificate issued by the fabricator/manufacturer. Upon request, it has to be readily available to the staff of the Regulatory Authority of the importing country. This certification by the manufacturer of the conformity of each batch is essential to exempt the importer from re-control (re-analysis).

A batch certificate issued by the fabricator/manufacturer in the exporting country must accompany each batch transferred between countries having an MRA in force. This certificate will be issued further to a full qualitative and quantitative analysis of all active and other relevant constituents to ensure that the quality of the products complies with the requirements of the Marketing Authorisation of the importing country. This certificate will attest that the batch meets the specifications and has been manufactured in accordance with the Marketing Authorisation of the importing country, - detailing the specifications of the product, the analytical methods referenced, the analytical results obtained, and containing a statement that the batch processing and packaging quality control records were reviewed and found in conformity with GMP. The batch certificate will be signed by the person responsible for releasing the batch for sale or supply/export at the fabrication/manufacturing site.

The Regulatory Authorities of the following parties/countries have agreed these harmonised requirements: Australia, Canada, European Community, New Zealand and Switzerland.

Click on the link below for the certificate template:

Content of the Fabricator’s/Manufacturer’s Batch Certificate for Drug/Medicinal Products Exported to Countries under the Scope of a Mutual Recognition Agreement (MRA)

Last Updated : 14-March-2001