DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)10.7 OTHER CONSIDERATIONS FOR IMPLEMENTATIONVARIATION APPLICATIONSChange in patient pack size with or without involving new pack type shallbe submitted to Variation Section, Centre for Post Product Registration.Supporting documents required are:a. Justification for the new pack size and/or type;b. Accelerated stability data (3 or 6 months) and stability report for newpack types; andc. Commitment to provide complete real time stability data and reportwhen available.List of products with recommended pack sizes for oral liquid preparationsand dermatological are as in Table 1 and Table 2 respectively.For tablets and capsules in loose pack, the maximum packing size willdepend on the highest dosage and frequency per patient‟s treatment orone month supply.10.8 IMPLEMENTATION TIMELINEImplementation of patient dispensing pack has been conducted in aphased manner to ensure smooth transition while ensuring no supplydisruption to patients. This implementation is effective since 1 March2008 on a voluntary basis and mandated on 1 September 2008.All products manufactured from 1 September 2008 regardless whether itis imported or locally manufactured will need to conform to the principlesof this guide.10.9 CONCLUSIONPatient Dispensing Pack is convenient, safe and improves quality ofdispensed medicines. It will increase efficiency in dispensing and improvesafety by reducing the risk and possibility of error. It will also result in areduction in drug waste and better use of resources.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 420