DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)a) Approval of Additional Indication(s) in country of origin;b) Approval status in reference countries, its corresponding approval letter andapproved Package Insert;c) Approval Indication status in ASEAN Member States and its approvedcorresponding package insert;d) Revised Package Insert;e) World Wide Approval status;f) Patient Information Leaflet (PIL);g) Clinical Expert Reports;h) Synopsis of Individual Studies;i) Clinical Studies Report/ In-House Clinical Trials;j) Published Clinical Papers;k) Current Periodic Safety Update Report (PSUR).16.5 APPLICATION FOR A CONVENIENT PACKa) This type of application is referring to registered products which are packedtogether in a single packaging unit for convenience of the consumers, such asa Confinement Set or Set Jamu Bersalin.b) Individual registered products are allowed to be packed together andmarketed as a convenient pack, provided that the application is justifiedsatisfactorily.c) Shall consist of registered products from the category of natural productand/or health supplement only.d) Application for a convenient pack shall be made via the process of variationType II.The holder has to submit the convenient pack label and also the individuallabel via application for variation under Part D2 (outer label). The convenientpack label shall contain the same information as in the primary label.For details of variation, please refer to Section E: 16.1 Variation.e) Individual registered products involved in the convenient pack can be soldindividually or as a pack.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 115