DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)period of time, the supportive documents will be rejected and a new applicationshall be submitted.16.2 CHANGE OF MANUFACTURING SITEChange of Manufacturing Site (COS) refers to change of manufacturing site forcertain part or all of the manufacturing process of a product, but it does not coverchanges related to a new site, where only:c) batch release takes place ORd) to a new packager (secondary packaging or labelling), as these changes arecovered under applications for amendments to the particulars of a registeredproduct (variation). Please refer to paragraph Section E: 16.1 Variation.However, a change of manufacturing site for biologics shall require a new productapplication only if the change is extensive that will have an impact on the quality,safety and efficacy profile of the final product.Upon receipt of complete application, the application shall be processed within fortyfive(45) working days.16.2.1 CONDITIONS ON APPLICATION FOR COS:Change in Manufacturing Site is only applicable in the following situations:a) a change in manufacturing site for the same company, including rationalization inthe event of mergers; andb) a company which previously contracts out the manufacture of its product(s),transfers the manufacture of the product to its own premises.A change in manufacturing site between contract manufacturers is not routinelyallowed but may be considered in a crisis situation (refer Type V COS: CrisisSituation)Validity of registration for a product which has been approved for change ofmanufacturing site remains unchanged, without any extension of the validity.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 110