The World Health Organization (WHO) Certification Scheme on the quality of pharmaceutical products moving in international commerce is an international voluntary agreement to provide assurance to countries participating in the Scheme about the quality of pharmaceutical products moving in international commerce. The primary document of the Scheme is the certificate of a pharmaceutical product (CPP).

Contacts list

Competent authorities of countries participating in the WHO certification scheme on the quality of pharmaceutical products moving in international commerce. Contacts list

Some National and Regional Regulatory Authorities have indicated that, during the COVID-19 crisis, they will no longer be in a position to issue and send paper copies of Certificates issued in the context of WHO Certification scheme on the quality of pharmaceutical products moving in international commerce. Instead, and in order to maintain this critical service, they will use a secure e-signature process. WHO agrees with this initiative, which does not contradict the current WHO Guideline. WHO recommends other regulators issuing Certificates consider this approach too. NRAs receiving Certificates are urged by WHO to accept the electronic signature. This would be an example of regulatory flexibility in response to the COVID-19 pandemic.

Further information:
European Medicines Agency (EMA) notification on new electronic certificates
EMA Explanatory note on format, safety features and Agency’s measures

The model certificates shown in this web site conform to the format recommended by the World Health Organization. Although the contents of the model certificates are consistent throughout the Scheme, certificates issued by different national authorities may have a different format and occasionally different wording.

The national regulatory authority of the exporting country should be able to provide more specific information.

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 under section 4.9 of the guidelines.