⁶ The WHO type certificate of a Pharmaceutical Product refers to the certificate issued by the international drug regulatory authority. Further information, and the full text of the WHO document "Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce" can be found in the website http://www.who.int/medicines/

When there are differences between the product for which this application is submitted and that marketed in the country or countries which provided WHO-type certificate(s), provide arguments and/or data to support the applicability of the certificates despite the differences. Depending on the case, it may be necessary to provide validation data for differences in site of manufacture, specifications, formulation, etc.

Note that only minor differences are likely to be acceptable. Differences in container labelling need not normally be justified.