(1995; 156 pages)
7.3 The WHO Certification Scheme
The WHO Certification Scheme requires that each Member State intending to use the Scheme to support the export of pharmaceutical products should first satisfy itself that it possesses, among other things, an effective national licensing system for pharmaceutical products, manufacturers and distributors and GMP consonant with those recommended by WHO. The responsibility to determine whether these requirements are met is left to the judgement of each exporting country.
In reality, national drug regulatory practices often differ from country to country in their practices, emphasis, standards, and rigour of enforcement. This implies that the certification by national regulatory authorities gives only a partial assurance and that each importing country needs to have a functioning drug regulatory system supported by a quality control laboratory to verify the quality of drugs being imported.
The provisions of the WHO Certification Scheme leave it for the authorities of the exporting country to decide which governmental institution will be responsible for the issue of product certificates for exported drugs. The situation is simple in those countries where there is a single central drug regulatory authority but becomes more complicated in countries with a federal structure.
A similar but a much more complex situation observed during the assessment pertains to countries which have not yet acceded formally to the Scheme but issue a certificate for products they export.
The guidelines on the implementation of the WHO Certification Scheme state that the product certificate should be considered as a confidential document and that it should not be reproduced. However, these restrictions are overruled in cases where pharmaceutical products are re-exported.
In the case of analytical batch certificates a practice is spreading that when a batch of a product is re-exported, a copy of the analytical batch certificate issued by the manufacturer is provided to the recipient of the drugs.
As originally intended, the Certification Scheme was to operate in situations where a pharmaceutical product is sold directly from the country of manufacture to the country of final destination. Under this condition, even if commercial intermediates (trade representatives, import companies, wholesalers) are involved in the arrangements, there still exists a possibility of direct contact between the regulatory authorities of the exporting and importing countries.
The study showed that at present such direct arrangements pertain only to a part of international trade in pharmaceuticals. Frequently, importation is done from stocks held in an intermediate (third) country. The activities in an intermediate country, as evidenced by the survey, will sometimes include repacking from bulk containers into smaller containers and/or labelling of original containers. This situation will make the use of the Certification Scheme much more complex than originally envisaged unless a special provision under these circumstances is included in the Scheme.