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14 October 2022GUIDELINE FOR THE API MASTER FILE (AIMF) PROCEDURE This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines
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The extranetwhointapi-master-file-apimf-procedureapi master file apimf is a specific file that contains information regarding procedures and master files related to a particular API.
Manufacturers and companies involved in the production and distribution of APIs are required to file the extranetwhointapi-master-file-apimf-procedureapi master file apimf.
The extranetwhointapi-master-file-apimf-procedureapi master file apimf can be filled out online on the WHO extranet platform by providing all the necessary information and documentation.
The purpose of the extranetwhointapi-master-file-apimf-procedureapi master file apimf is to ensure transparency and regulatory compliance in the production and distribution of APIs.
The extranetwhointapi-master-file-apimf-procedureapi master file apimf must include details on the manufacturing process, quality control, testing methods, and specifications of the API.
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