Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
(2008; 10 pages)


The main objective of the Active Pharmaceutical Ingredient Master File (APIMF) procedure is to allow valuable confidential intellectual property or "know-how" of the manufacturer of the active pharmaceutical ingredient (API) to be protected, while at the same time allowing the applicant for prequalification or prequalification variation (from now on named in the text as the applicant) to take full responsibility for the finished pharmaceutical product (FPP) and the quality and quality control of the API. The WHO Prequalification Programme thus has access to all the information necessary for an evaluation of the suitability of the use of the API in the FPP. The APIMF procedure is a possibility offered to applicants for WHO prequalification of medicinal products and the manufacturers of their APIs. Other means of submission of scientific data on the API include:

  • a valid certificate of suitability of pharmacopoeial monographs with which the API complies with all appendices, and adding information which is not covered by the certificate;
  • by submitting scientific information on the API to the extent available and organized according to the current guidance documents, available on the WHO Prequalification web site ( In this case, the API manufacturer should provide a signed declaration that the synthesis and subsequent purification is conducted in accordance with what is presented in the dossier.

In addition, the WHO pharmaceutical starting materials certification scheme (SMACS) can be used to attest the relevant data as covered in the scheme. (WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-eighth report. Geneva, World Health Organization, 2004. WHO Technical Report Series, No. 917, Annex 3.)

These guidelines are intended to assist applicants in the compilation of the information on APIs in their dossiers for prequalification or when submitting a variation to a dossier on a prequalified product (named in the text from now on as product dossier) when the APIMF procedure is used. It is also intended to help APIMF holders in the compilation of their APIMFs.

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