WHO TRS (Technical Report Series) 943 Annex 6

Guidance on variations to a prequalified product dossier

Preface:

This guidance document was technically and structurally inspired by the Guideline on dossier requirements for type IA and IB notifications.1 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. 

See below PDF for complete details:

WHO TRS (Technical Report Series) 943 Annex 6: