Common use of Certification of manufacturers Clause in Contracts

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. 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 supervision of the manufacture of medicinal products will 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, 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 shall 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 shall 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. 3. At at the request of an exporter, importer or the competent authority of the other Party, the Authorities authorities responsible for granting manufacturing authorisations and for supervising manufacturers supervision of the manufacture 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 Authoritiesauthorities, and - — complies with the national GMP requirements recognised as equivalent by the two partiesParties, and which are listed referred to in Appendix 1 to this Sectoral Annex. In case Section I. Where different GMP requirements would be are used as a reference (in line with the provisions in point 3(b) of Section 3, 3 bIII), 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 the certificate is attached as Appendix 2; it may will be modified decided by the Joint Committee, as established in Article 12 of the AgreementSectoral Group. 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 calendar days. Batch certification

Certification of manufacturers. 3. At the request of an exporter, importer or the competent authority of the other Party, the Authorities authorities responsible for granting manufacturing authorisations and for supervising manufacturers supervision of the manufacture 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 Authoritiesauthorities, and - — complies with the national GMP requirements recognised as equivalent by the two partiesParties, and which are listed referred to in Appendix 1 to this Sectoral Annex. In case Section I. Where different GMP requirements would be are used as a reference (in line with the provisions in point 3(b) of Section 3, 3 bIII), 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 the certificate is attached as Appendix 2; it may will be modified decided by the Joint Committee, as established in Article 12 of the AgreementSectoral Group. 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 calendar days. Batch certification

Certification of manufacturers. 3. At at the request of an exporter, importer or the competent authority of the other Party, the Authorities authorities responsible for granting manufacturing authorisations and for supervising manufacturers supervision of the manufacture 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 Authoritiesauthorities, and - — complies with the national GMP requirements recognised as equivalent by the two partiesParties, and which are listed referred to in Appendix 1 to this Sectoral Annex. In case Section I. Where different GMP requirements would may be used as a reference (in line with the provisions in point 3(b) of Section 3, 3 bIII), 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 the certificate is attached as Appendix 2; it may will be modified decided by the Joint Committee, as established in Article 12 of the AgreementSectoral Group. 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 calendar days. Batch certification

Certification of manufacturers. 3. At the request of an exporter, importer or the competent authority of the other Party, the Authorities authorities responsible for granting manufacturing authorisations and for supervising manufacturers supervision of the manufacture 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 Authoritiesauthorities, and - — complies with the national GMP requirements recognised as equivalent by the two partiesParties, and which are listed referred to in Appendix 1 to this Sectoral Annex. In case Section I. Where different GMP requirements would may be used as a reference (in line with the provisions in point 3(b) of Section 3, 3 bIII), 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 the certificate is attached as Appendix 2; it may will be modified decided by the Joint Committee, as established in Article 12 of the AgreementSectoral Group. 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 calendar days. Batch certification