DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)APPENDIX 13:SUPPORTING DOCUMENTS REQUIRED FOR CHANGE OFMANUFACTURING SITE (COS) APPLICATIONNoDocument To Be Submitted1. Letter of authorization/ appointment from theproduct owner to authorize Product RegistrationHolder to submit the change of site application.In case of a contract manufacturer, a letter ofacceptance from the proposed contractmanufacturer to manufacture the product.TypeITypeIITypeIIITypeIVTypeV√ √ √ √ √2. Letter from the manufacturer/ product owner toclarify/ explain the need to change site ofmanufacture.For Type I:Letter of declaration stating the reason(s) forchange of manufacturing site and clearly state theproposed and current name and address ofmanufacturer3. Written declaration from the manufacturer to certifythat the manufacturing process, and the releaseand expiry (check) specifications of the product asthe same as already approved.OR√ √ √ √ √√ √ √ √ √If there are minor changes, to declare the „minorchanges‟ & justify the need for such changes.4. „Release‟ and „end-of-shelf life‟ specifications fromproposed site. √ √ √ √ √5. Original copy of the Certificate of Free Sale (CFS)and Good Manufacturing Practice (GMP)/Certificate of Pharmaceutical Product (CPP) fromthe source country of the new manufacturing site inthe case of an imported productOR√ √ √ √ √Letter of confirmation on GMP status or validmanufacturer‟s license for the new manufacturingsite.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 480