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(2013; 62 pages)
The variation guidelines have been completely updated and expanded, bringing them into line with the principles of the new generic quality guidelines, WHO Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part.
This guidance supersedes the guidance published in 2007.
An applicant is responsible for the safety, efficacy and quality of a product throughout its life-cycle. Therefore, the applicant is required to make changes to the details of the product in order to accommodate technical and scientific progress, or to improve or introduce additional safeguards for the prequalified product. Such changes, whether administrative or substantive, are referred to as variations and may be subject to acceptance by WHO/PQP prior to implementation. Technical requirements for the different types of variations are set out in these guidelines in order to facilitate the submission of appropriate documentation by applicants and their assessment by WHO/PQP and to ensure that variations to the medicinal product do not result in health concerns.
The procedure for submitting variations is not within the scope of these guidelines. Advice on the procedure for submitting a variation and current review timelines are set out on the WHO/PQP web site which may be updated from time to time. Applicants are advised to consult information on the web site whenever they are considering the submission of a variation application.
These guidelines apply to applicants intending to make changes to the quality sections of product dossiers for an API or an FPP. This guidance should be read in conjunction with the WHO Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part5 as well as other related WHO guidelines. This guidance document is applicable only to APIs and excipients manufactured by chemical synthesis or semi-synthetic processes and FPPs containing such APIs and excipients. APIs produced by fermentation and APIs of biological, biotechnological or herbal origin are treated as special cases. The applicant is requested to contact WHO/PQP regarding planned variations to such products.