(1995; 156 pages)
1.3 Types of Certificates
The different types of certificates developed by WHO over the last two decades under the Certification Scheme, as well as examples of other certificates issued by drug regulatory authorities in the exporting countries are described below.
1.3.1 WHO-type Certificate
a) Certificate of Pharmaceutical Product (WHO 1975 type)
The 1975 version of the WHO-type Certificate of a Pharmaceutical Product is a certificate to be issued by a competent authority (regulatory authority) of the exporting country stating:
(i) that the product has been authorized to be placed on the market for use in the country including the number of permit and date of issue, or that the product has not been authorized to be placed on the market for use in the country and the reasons why;
(ii) that: a) the manufacturing plant in which the product is produced is subject to inspections at suitable intervals; and b) the manufacturer conforms to GMP requirements as recommended by WHO in respect of products to be sold or distributed within the country of origin or to be exported.
The certificate combines (i) and (ii) above in a single document (see annex 2).
b) Certificate of a Pharmaceutical Product (WHO 1988 type)
The 1988 format of the Certificate of a Pharmaceutical Product is similar to the 1975 version, but in addition the competent authority of the exporting country is required to provide copies of the complete text of all labelling and product information which is authorized in the country of origin (see annex 3).
c) Certificate of a Pharmaceutical Product (WHO 1992 type)
This is intended for use by the competent authority of an importing country in two situations: a) when the product in question is under consideration for a product license that will authorize its importation and sale; and b) when administrative action is required to renew, extend, vary or review such a license (see annex 4). The certificate provides information on the following:
i) whether a product is licensed to be placed on the market, and if not, the reasons why;
ii) whether the applicant manufactures the dosage forms, packages and/or labels a finished dosage form manufactured by an independent company, or is involved in none of the above;
iii) if the manufacturer of the product has been inspected and the periodicity of inspection;
iv) if the certificate is provisional, pending technical review;
v) whether the information submitted by the applicant satisfies the certifying authority on all aspects of the manufacture of the product undertaken by another party;
vi) states the names of the importing and exporting (certifying) countries.
d) Statement of Licensing Status (WHO 1992 type)
This is an attestation issued by a national regulatory authority of an exporting country stating that a license has been issued for a specified product or products for use in the exporting country. It is intended for use by importing agents when considering bids made in response to an international tender and is useful only to facilitate the screening and preparation of information (see annex 4).
e) Batch Certificate (WHO-type)
A certificate issued by either the manufacturer or by the competent authority of an exporting country confirming that the quality of a specific batch of the product conforms to specifications approved at the time of issuance of product license by the competent authority in the exporting country. The batch certificate indicates the name, dosage form, batch number, expiry date, storage condition of the product as well as a reference to the Certificate of a Pharmaceutical Product (see annex 4).
1.3.2 Other Certificates (non WHO-type)
a) Free Sale Certificate
A certificate issued by a national regulatory authority of an exporting country based on national legislation confirming that the product is freely sold in the country but without any indication that the product is evaluated for safety and efficacy and is registered for use in the country.
b) GMP Certificate
A certificate issued by a national regulatory authority of an exporting country confirming that the manufacturer complies with GMP requirements.
c) Analytical Batch Certificate
A certificate issued by a manufacturer confirming that the quality of a specific batch corresponds to the specifications for the product at the time when the batch was released. It contains results of analytical tests but does not mention the relevant Certificate of a Pharmaceutical Product issued by the regulatory authority of the exporting country as recommended by WHO.