Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce
Eligibility for participation
2.1 Any Member State intending to participate in the Scheme may do so by notifying the Director-General of the World Health Organization, in writing, of:
- its willingness to participate in the Scheme;
- any significant reservations it intends to observe relating to this participation; and
- the name and address of its national drug regulatory authority or other competent authority.
2.2 These notifications will be subsequently announced in the monthly WHO Pharmaceutical Newsletter. An updated consolidated list will be published annually in the Newsletter and will be available to governments at other times from: the Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland. (See also section 3.3)
2.3 A Member State may opt to participate solely to control the import of pharmaceutical products and active substances. This intention should be stated explicitly in its notification to the World Health Organization.
2.4 A Member State intending to use the Scheme to support the export of pharmaceutical products should first satisfy itself that it possesses:
- an effective national licensing system, not only for pharmaceutical products, but also for the responsible manufacturers and distributors;
- GMP requirements, consonant with those recommended by WHO, to which all manufacturers of finished pharmaceutical products are required to conform;
- effective controls to monitor the quality of pharmaceutical products registered or manufactured within its country, including access to an independent quality control laboratory;
- a national pharmaceuticals inspectorate, operating as an arm of the national drug regulatory authority, and having the technical competence, experience and resources to assess whether GMP and other controls are being effectively implemented, and the legal power to conduct appropriate investigations to ensure that manufacturers conform to these requirements by, for example, examining premises and records and taking samples;
- administrative capacity to issue the required certificates, to institute inquiries in the case of complaint, and to notify expeditiously both WHO and the competent authority in any Member State known to have imported a specific product that is subsequently associated with a potentially serious quality defect or other hazard.
2.5 Each Member State assumes the responsibility to determine, through a process of self-evaluation, whether it satisfies these prerequisites. The Scheme contains no provision, under any circumstance, for external inspection or assessment, either of a competent national authority or of a manufacturing facility. However, 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, and inspector training activities.