3.1 Three documents can be requested within the scope of the Scheme:
- a Certificate of Pharmaceutical Product (product certificate);
- a Statement of Licensing Status of Pharmaceutical Product(s); and
- a Batch Certificate of a Pharmaceutical Product.
3.2 Proposed formats for these documents are provided in Appendices 1, 2 and 3 of these guidelines. To facilitate their use, they are presented in forms suitable for generation by computer. All participating countries are henceforth urged to adopt these formats to facilitate the interpretation of certified information. Requests for the provision of certificates offering more limited attestations - for instance, that the manufacturer complies with GMP or that the product is authorized for “free sale” within the country of export - are discouraged. Similarly, requests should not be made for the certification of information going beyond the scope of the Scheme. When manufacture takes place in a country other than that where the product certificate is issued, an attestation that such manufacture complies with GMP may still be provided as an attachment to the product certificate on the basis of inspections undertaken for registration purposes. The explanatory notes attached to the three documents referred to above are very important. While they are not part of the documents, they should always be attached to them.
3.3 A list of addresses of competent national regulatory authorities participating in the Scheme that are responsible for the registration of pharmaceutical and/or veterinary products, together with details of any reservations they have declared regarding their participation in the Scheme may be obtained from WHO as indicated in section 2.2.
3.4 The competent authority in each country participating in the Scheme should issue guidelines to all agents responsible for importing pharmaceutical products for human and/or veterinary use that operate under its jurisdiction, including those responsible for public sector purchases, to explain the contribution of certification of the drug regulatory process and the circumstances in which each of the three types of documents will be required.
Certificate of a Pharmaceutical Product
3.5 The Certificate of a Pharmaceutical Product (Appendix 1), issued by the exporting country, is intended for use by the competent authority within an importing country in two situations:
- when the product in question is under consideration for a product licence that will authorize its importation and sale;
- when administrative action is required to renew, extend, vary or review such a licence.
3.6 All requests for certificates should be channelled through the agent in the importing country (see section 3.4) and the product-licence holder or other commercially interested party in the exporting country (“the applicant”). The applicant should submit the following information for each product to the authority issuing the certificate:
- the name and dosage form of the product;
- the name and the amount of active ingredient(s) per unit dose (the International Nonproprietary Name(s), where such exist(s), should be used);
- the name and address of the product-licence holder and/or manufacturing facility;
- the formula (the complete qualitative composition including all excipients); this is particularly important when no product licence exists or when the formulation differs from that of the licensed product;
- product information for health professionals and for the public (patient information leaflets) as approved in the exporting country.
For product information to be attached to the certificate, see section 4.7.
3.7 The certificate is a confidential document. As such, it can be issued by the competent authority in the exporting country (“the certifying authority”) only with the permission of the applicant and, if different, of the product-licence holder.
3.8 The certificate is intended to be incorporated into a product-licence application in the importing country. Once prepared, it is transmitted to the requesting authority through the applicant and, when applicable, the agent in the importing country.
3.9 When any doubt arises about the status or validity of a certificate, the competent authority in the importing country should request a copy directly from the certifying authority, as provided for in section 4.9 of these guidelines.
3.10 In the absence of any specific agreement, each certificate will be prepared exclusively in the working language(s) of the certifying authority. The applicant will be responsible for providing any notarized translation that may be required by the requesting authority.
3.11 Since the preparation of certificates imposes a significant administrative load on certifying authorities, the service may need to be financed by charges levied upon applicants.
3.12 Supplementary attestations are obtainable only at the discretion of the certifying authority and with the permission of the applicant. The certifying authority is under no obligation to supply additional information. Requests for supplementary information should consequently be referred to the applicant, and only in exceptional circumstances to the certifying authority.
Statement of Licensing Status
3.13 The Statement of Licensing Status of Pharmaceutical Product(s) (Appendix 2) attests only that a licence has been issued for a specified product, or products, for use in the exporting country. It is intended for use by importing agents when considering bids made in response to an international tender, in which case it should be requested by the agent as a condition of bidding. It is intended only to facilitate the screening and preparation of information. The importation of any product that is provisionally selected through this procedure should be determined on the basis of a Certificate of a Pharmaceutical Product.
3.14 A Batch Certificate of a Pharmaceutical Product (Appendix 3) refers to an individual batch of a pharmaceutical product, and is a vital instrument in drug procurement. The provision of a Batch Certificate is usually a mandatory requirement in tender and procurement documents.
3.15 A Batch Certificate is normally issued by the manufacturer and only exceptionally, as in the case of vaccines, sera and some other biological products, by the competent authority of the exporting country. The Batch Certificate is intended to accompany and provide an attestation concerning the quality and expiry date of a specific batch or consignment of a product that has already been licensed in the importing country. The Batch Certificate should include the specifications of the final product at the time of batch release and the results of a full analysis undertaken on the batch in question. In most circumstances these certificates are issued by the manufacturer to the importing agent (i.e. the product-licence holder in the importing country), but they must be made available at the request of - or in the course of any inspection made on behalf of - the competent national authority.