Who Certification Scheme on the Quality of Pharmaceutical Product

The WHO Certification Scheme in its present form and with the model certification documents provides transparent information, particularly about the regulatory status of a given product in the exporting country. The advantage of using the same format and content of certificate worldwide is that this facilitates and rationalizes the issuance of certificates and also their interpretation at the receiving end. If used properly, the information provided under the scheme, product certificate and batch certificate, can provide an important basis for product registration in the importing country. On the other hand, it must be acknowledged that the scheme in its present form still has an inherent weakness in that it is based on the self-assessment of regulatory competence and there is no external assessment mechanism. In order to strengthen this point the guidelines on the scheme mention under section 2.5 that should a Member State so wish, it could approach WHO, or a well-recognized drug regulatory authority, to occasionally delegate consultants to act as advisors in the course of national inspections.