Division 7 Format of Information exchange

Authorisations, inspection reports, GMP certificates and information on GMP non-compliance shall follow the format in accordance with the procedures published by the EU.

Certificates on OCABR as well as notices of non-compliance shall follow the format in accordance with the procedures on OCABR published by the Council of Europe.

Batch certificates for medicinal products that accompany each batch shall document at least the date of manufacture, the date of expiry, results of the qualitative and quantitative analysis and the name and address of the laboratory where such analysis was performed, the name and address of the manufacturer(s) and, where applicable, the importer. They shall also include a reference to the GMP certificate issued for the manufacturer and, where applicable, the importer. Batch certificates shall follow the provisions in accordance with the procedures published by the EU.