Certification of manufacturers Sample Clauses

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 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.
Sample 1Sample 2Sample 3See All (8)
AutoNDA by SimpleDocs
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 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. 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 releasing the batch for sale or...
Sample 1Sample 2
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. 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: (a) are appropriately authorised to manufacture and/or control the relevant medicinal product/drug or to carry out the relevant specified operations, (b) are regularly inspected by the authorities, and (c) comply with the GMP requirements recognised as equivalent by the two Parties. The certificates of manufacturing authorisation/licence will also identify the site(s) of manufacture. A Canadian and a European Community example of such certificates are attached at Appendix 7 for illustrative purposes. Certificates of manufacturing authorisations/licences will be issued expeditiously, and the time taken should not exceed 30 days. In cases when a new inspection has to be carried out, this period may be extended to 60 days.
Sample 1Sample 2
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: (a) is appropriately authorised to manufacture the relevant medicinal product or to carry out the relevant specified manufacturing operation; (b) is regularly inspected by the authorities; and (c) complies with the national GMP requirements recognised as equivalent by the two Parties in accordance with Article 2.3
Sample 1
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: (a) are appropriately authorised to manufacture and/or control the relevant medicinal product/drug or to carry out the relevant specified operations, (b) are regularly inspected by the authorities, and (c) comply with the GMP requirements recognised as equivalent by the two Parties. The Certificates of Manufacturing Authorization/Licence will also identify the site(s) of manufacture. A Canadian and a European Community example of such certificates are attached at Appendix 7 for illustrative purposes. Certificates of manufacturing authorizations/licences will be issued expeditiously, and the time taken should not exceed 30 calendar days. In cases when a new inspection has to be carried out, this period may be extended to 60 calendar days.
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.

  • Supply of Materials The following materials will be supplied by the department Name of Materials Rate. Place of delivery 1.

  • 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. a. The contractor shall notify all potential subcontractors and suppliers and lessors of their EEO obligations under this contract. b. The contractor will use good faith efforts to ensure subcontractor compliance with their EEO obligations.

  • Manufacturer’s 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.

  • Review of Materials During the term of this Agreement, Client shall ensure that all prospectuses, statements of additional information, registration statements, proxy statements, reports to shareholders, advertising and sales literature or other materials prepared for distribution to Fund shareholders or the public, which refer to the Subadviser in any way, prepared by employees or agents of Client or its affiliates are consistent with information previously provided by Subadviser. Subadviser shall promptly notify the Client of any changes to information pertaining to the Subadviser and stated in the materials described in this Section 6(g).

  • Inspection and Rejection of Nonconforming Goods The Buyer has the right to inspect the Goods on or after the Delivery Date. Buyer, at its sole option, may inspect all or a sample of the Goods, and may reject all or any portion of the Goods if it determines the Goods are nonconforming or defective. If Buyer rejects any portion of the Goods, Buyer has the right, effective upon written notice to Seller, to: (a) rescind the Order in its entirety; (b) accept the Goods at a reasonably reduced price; or (c) reject the Goods and require replacement of the rejected Goods. If Buyer requires replacement of the Goods, Seller shall, at its expense, promptly replace the nonconforming Goods and pay for all related expenses, including, but not limited to, transportation charges for the return of the defective goods and the delivery of replacement Goods. If Seller fails to timely deliver replacement Goods, Buyer may replace them with goods from a third party and charge Seller the cost thereof and terminate this Order for cause pursuant to Section 19. Any inspection or other action by Buyer under this Section shall not reduce or otherwise affect Seller's obligations under the Order, and Buyer shall have the right to conduct further inspections after Seller has carried out its remedial actions.

  • 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)

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!