Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999
(1999; 102 pages) View the PDF document
Table of Contents
Open this folder and view contentsOpening Ceremony
Open this folder and view contentsGood regulatory practice
Close this folderGood certification practice
View the documentRecommendations
Open this folder and view contentsCounterfeit drugs: challenges and solutions
Open this folder and view contentsCurrent issues in regulation and quality
Open this folder and view contentsInternational Conference on Harmonization: implementation and implications
Open this folder and view contentsDrug utilization studies
Open this folder and view contentsInternational Conference on Harmonization and the common technical document
Open this folder and view contentsKeynote address
Open this folder and view contentsGlobal and national efforts to reduce tobacco use
Open this folder and view contentsElectronic communication in the regulatory process
Open this folder and view contentsTransparency in monitoring the safety of medicines
Open this folder and view contentsPharmaceutical products for use in special groups
Open this folder and view contentsNeed for Bioequivalence
Open this folder and view contentsAntimicrobial resistance: battling the bugs
Open this folder and view contentsSafety issues of plasma-derived medicinal products
Open this folder and view contentsHerbal medicines
Open this folder and view contentsRegulation and access to essential drugs
View the documentParticipants
View the documentBack cover
 

Recommendations

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.

 

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Last updated: April 24, 2012