Certification of manufacturers Sample Clauses

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
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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).
Sample 1
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:
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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 Authorizations/Licences and for the supervision of the manufacture of medicinal products/drugs will certify that the sites used for manufacture and/or control:
Sample 1
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. 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 thirty calendar days. In exceptional cases, i.e. when a new inspection has to be carried out, this period may be extended to ninety 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 relea...
Sample 1

Related to Certification of manufacturers

  • Distribution of Materials You will keep an accurate record of the names and addresses of all persons to whom you give copies of the Registration Statement, the Prospectus, any Preliminary Prospectus (or any amendment or supplement thereto) or any Offering Circular or any Preliminary Offering Circular and, when furnished with any subsequent amendment to the Registration Statement, any subsequent Prospectus, any subsequent Offering Circular or any memorandum outlining changes in the Registration Statement or any Prospectus or Offering Circular, you will, upon request of the Manager, promptly forward copies thereof to such persons.

  • Manufacturer’s Warranty The Goods include the manufacturer’s standard limited parts warranty to replace defective parts covered under such warranty exclusive of labor. Labor is warranted by the Elevator Contractor for 90 days following installation. The manufacturer’s parts warranty may require that the Goods be maintained throughout the warranty period by an authorized manufacturer’s representative under a separate maintenance contract. Any warranty is conditioned on written notice to the Elevator Contractor within warranty period and contingent upon receipt of final payment to Elevator Contractor.

  • Manufacturers Promptly after obtaining actual knowledge thereof, notice of any Manufacturer Event of Default or termination or replacement of a Manufacturer Program;

  • Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract.

  • Manufacturers’ Warranties If a Lease Vehicle is covered by a Manufacturer’s warranty, the Lessee, during the Vehicle Term for such Lease Vehicle, shall have the right to make any claims under such warranty that the Lessor could make.

  • Distribution of Material A Union-designated employee will have access once per month to their worksite for the purposes of distributing Union information to other bargaining unit employees provided:

  • Responsibility for Quality of Materials and Installation Contractor acknowledges that he has full, total, and complete responsibility for providing materials, labor, and all other items necessary for providing the level of quality specified in the Contract Documents. He agrees that this responsibility is indivisible, non-delegable, non- transferable, and not diminished by any inspections provided by the Design Professional or his consulting engineers, nor by any inspections provided by the Owner. In recognition of this, Contractor will prepare for submission and review by the Design Professional, a written program describing the efforts that will be taken to insure the proper quality level is achieved. The program shall be submitted prior to the issuance of a Proceed Order.

  • Inspection and Rejection of Nonconforming Goods (a) Buyer shall inspect the goods within five days of receipt (“Inspection Period”). Xxxxx will be deemed to have accepted the goods unless it notifies Seller in writing of any Nonconforming Goods during the Inspection Period and furnishes documentation reasonably required by Seller. “

  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

  • Removal of Materials If you decide you would like to remove your Materials from the Service, you may provide written notice to Prime Publishing by either deleting the image through the Prime Publishing interface or by contacting Prime Publishing customer service, and Prime Publishing will remove such Materials from the Service within a reasonable period of time. 5) License for Name, Trademarks and Likenesses. You hereby grant to Prime Publishing, its Affiliates and sublicensees a nonexclusive, worldwide, royalty-free license to use all trademarks, trade names, and the names and likenesses of any individuals that appear in the Materials. You grant Prime Publishing, its Affiliates and sublicensees the right to use the name that you submit in connection with the Materials. 6) Specifications and Guidelines. You agree to submit Materials to us in accordance with all guidelines for use of the Service posted on the Prime Publishing web site or of which you are otherwise notified ("Guidelines"), as these Guidelines may be changed in the future. 7)

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