The workshop discussed the general applicability and practical use of certificates, including the WHO Certification Scheme.
• The usefulness of the WHO Certification Scheme was endorsed by participants.
• The practical usefulness of certificates depends on the credibility of certifying authorities, as well as the quality of information provided.
• Certificates cannot be used by importing country authorities as a replacement for the technical assessment and professional judgement contained in application dossiers for marketing authorization.
• The value of certificates is diminished if products are not authorized for marketing in the certifying country.
The following recommendations were made:
1. WHO should continue to promote the use of the Certification Scheme with a view to assuring its global application.
2. National authorities should insist that manufacturers, traders and other companies comply with the WHO Certification Scheme, and should refuse other certificates.
3. WHO should trigger feedback information on the practical utility of the Scheme, including the certification needs of importing countries, ways to prevent falsification of certificates, and how to improve the effectiveness of the Scheme.
4. WHO should work with national authorities to develop appropriate, safe and reliable mechanisms to permit exchange of verifiable product certificates and information on the Internet.
5. Exporting countries should ensure that maximum information concerning all the manufacturers involved in production - and at least information on the manufacturer responsible for batch release - is provided on certificates.
6. WHO should foster further development of the Certification Scheme to: (a) include provisions for additional information on manufacturers, and (b) address the case of products with no marketing authorization in the certifying country. A declaration by the company’s authorized person before the certifying country authority, including information on product development, stability testing, and prior marketing should be given.
7. Member States are requested to ensure that a WHO product certificate with an original signature is provided.