This guidance document was technically and structurally inspired by the Guideline on dossier requirements for type IA and IB notifications. It is
intended to provide information on how to present an application to implement a change to a prequalified product.
References to compendial monographs (British Pharmacopoeia (BP), International Pharmacopoeia (Ph Int), Japanese Pharmacopoeia (JP), European Pharmacopoeia (Ph Eur) or United States Pharmacopeia (USP)) or to guidelines (WHO, International Conference on Harmonisation (ICH)-region and associated countries) are included to assist applicants. However, it remains the applicant’s responsibility to ensure that the most recent revisions of all relevant legislation and guidelines are taken into account in the preparation of each part of their dossier. The guidelines referred to in each section provide useful information on the content expected in that section. However, this list should not be regarded as exhaustive.
Where a variation requires consequential revision of the summary of product characteristics (SmPC), labelling and package leaflet or insert, this is considered as part of the variation.
This guidance document is applicable only to active pharmaceutical ingredients (APIs) and excipients manufactured by chemical synthesis or semisynthetic processes and finished pharmaceutical products (FPPs) containing such APIs and excipients. Variations to a biological API and/or biological excipient, or to biological finished products are assessed as major changes. In such a case the applicant should refer to guidance documents that
specifically address biological APIs, excipients and finished products (e.g. ICH Q5A (R1), Q5B, Q5C, Q5D, Q5E, Q6B).
This guidance document applies to multisource (generic) FPPs that have been prequalified by WHO. Whenever FPPs have been prequalified on the basis of approval by a drug regulatory authority of the ICH region and associated countries (innovator products or generic products) subsequent applications for variations also need to be approved by the same drug regulatory authorities and WHO should be notified of the approval of the changes. Applicants are advised to refer to the Letters of Prequalification.