Certification of manufacturers. 3. At the request of an exporter, importer or the competent authority of the other Party, the Authorities responsible for granting manufacturing authorisations and for supervising manufacturers of medicinal products will certify that the manufacturer: - is appropriately authorised to manufacture the relevant medicinal product or to carry out the relevant specified manufacturing operation, - is regularly inspected by the Authorities, and - complies with the national GMP requirements recognised as equivalent by the two parties, and which are listed in Appendix 1 to this Sectoral Annex. In case different GMP requirements would be used as a reference (in line with the provisions in Section 3, 3 b), this is to be mentioned in the certificate. The certificates will also identify the site(s) of manufacture (and contract testing laboratories, if any). The format of certificate is attached as Appendix 2; it may be modified by the Joint Committee, as established in Article 12 of the Agreement. Certificates will be issued expeditiously, and the time taken should not exceed 30 calendar days. In exceptional cases, such as when a new inspection has to be carried out, this period may be extended to 60 days. Batch certification
Certification of manufacturers. At the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for granting manufacturing authorisations and for supervision of the manufacture of medicinal products shall certify that the manufacturer: – is appropriately authorised to manufacture the relevant medicinal product, or to carry out the relevant specified manufacturing operation – is regularly inspected by the authorities – complies with the national GMP requirements recognised as equivalent by the two parties, and which are listed in Section I of this Chapter. Should different GMP requirements be used as reference, this is to be mentioned in the certificate. The certificates shall also identify the site(s) of manufacture (and contract quality control laboratories, if any).
Certification of manufacturers. 4.1 At the request of an exporter, importer or the regulatory authority of the other Party, the Inspection Service shall assess and, where appropriate, certify that the manufacturer:
Certification of manufacturers. At the request of an exporter, an importer or of an authority of the other Party, the authorities responsible for granting certificates of manufacturing authorisations/licences and for the supervision of the manufacture of medicinal products/drugs will certify that the sites used for manufacture and/or control:
Certification of manufacturers. At the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for granting manufacturing authorisations and for supervision of the manufacture of medicinal products shall certify that the manufacturer: — is appropriately authorised to manufacture the relevant medicinal product, or to carry out the relevant specified manufacturing operation, ▼M18 — is regularly inspected by the authorities, — complies with the national GMP requirements recognised as equivalent by the two parties, and which are listed in Section I of this Chapter. Should different GMP requirements be used as reference, this is to be mentioned in the certificate. For inspections in third countries, at the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for the inspection shall certify that the manufacturer complies or does not comply with the GMP requirements recognised as equivalent by the two Parties, and which are listed in Section I of this Chapter. The certificates shall also identify the site(s) of manufacture (and contract quality control laboratories, if any) and the date of the inspection. Certificates shall be issued expeditiously, and the time taken should not exceed 30 calendar days. In exceptional cases, i.e. when a new inspection has to be carried out, this period may be extended to 90 days. Batch certification Each batch exported shall be accompanied by a batch certificate established by the manufacturer (self-certification) after a full qualitative analysis, a quantitative analysis of all the active ingredients and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation. This certificate shall attest that the batch meets its specifications and shall be kept by the importer of the batch. It will be made available upon request of the competent authority. When issuing a certificate, the manufacturer shall take account of the provisions of the current WHO certification scheme on the quality of pharmaceutical products moving in international commerce. The certificate shall detail the agreed specifications of the product, the reference of the analytical methods and the analytical results. It shall contain a statement that the batch processing and packaging records were reviewed and found in conformity with XX X. The batch certificate shall be signed by the person responsible for releas...
