decree of the head of nadfc ri no. hk.03.1.23.10.11.08481 of 2011 on the criteria and procedure of drug registration 317 pages in bahasa indonesia this regulation replaces the regulation of the head of nadfc number hk.00.05.3.1950 year 2003 on the criteria and procedures of drug registration in order to meet the regulation of minister of health number 1010 year 2008 as amended by the regulation of minister of health number 1120 year 2008 and current situation of the asean harmonization on pharmaceuticals. the regulation specifies the categories of drug registration and its requirements as well the procedure and mechanism as mandatory. the name of the drug can be taken from a.generic it is based on indonesia pharmacopoeia or international non-proprietary names inn from who or b.trade name it is based on self-assessment and the responsibility of applicant . the decision of approval by head of the nadfc based on a.evaluation result of registration document and recommendation from the national committee of drug evaluation the committee of safety efficacy evaluation the committee of quality evaluation and the committee of product information and labeling evaluation. b.result of the pharmaceutical manufacturing facilities in-situ inspection. the marketing authorization is valid for a period of 5 years and can be extended through renewal mechanism. this rule also set u the detail of information and documents that should be submitted in drug registration as appear in annexes. the applicants are fully responsible for the completeness of submitted documents the validity of all information stated in drug registration document and the revision of data and product information. the drug importation should be done by pharmaceutical industries which hold marketing authorization. those industries may designate other pharmaceutical industries or pharmaceutical wholesaler to conduct their drug importation. the marketing authorization holder is obliged to monitor the safety efficacy and quality of their product and report it to the head of nadfc. any applicant who violates the provision may be subject to administrative sanctions namely a.written warning b.cancellation of drug registration process c.suspension of drug marketing authorization d.revoke of drug marketing authorization e.other administrative sanctions in accordance with the provisions of laws