Makarim & Taira S. Press
A new regulation has been issued by the Minister of Health, namely Regulation of the Ministry of Health No. 1010/MENKES/PER/XI/2008 regarding the Registration of Medicines (“Regulation 1010/2008”). Regulation 1010/2008 revokes previous Ministry of Health Regulation No. 949/Menkes/Per/VI/2000. Under Regulation 1010/2008, a medicine to be distributed in
Locally made medicines may only be registered by a pharmaceutical manufacturer with a pharmaceutical business license and the pharmaceutical manufacturer must also comply with the Cara Pembuatan Obat yang Baik (CPOB) procedures as evidenced by a CPOB certificate issued by the Head of the Drugs and Food Supervisory Agency (BPOM).
Contract medicines may only be registered by the contract giver which must be in the pharmaceutical industry and have a pharmaceutical business license and at least one other pharmaceutical production facility which complies with the CPOB.
Imported medicine may only be registered by a pharmaceutical company with written approval from the overseas pharmaceutical manufacturer. This written approval must contain provisions on transfer of technology so that within 5 years the medicine should be able to be produced in
Medicines which have already obtained a Distribution License may be re-evaluated if:
▫ the risk of side effects is more than its effectiveness which is revealed after the product is introduced to the market;
▫ their effectiveness is no better than a placebo;
▫ they do not satisfy the biological/bio equivalency availability (ketersediaan hayati/bioekivalensi) requirements;
A re-evaluated medicine must be re-called by the pharmaceutical manufacturer which registered the medicine. Re-evaluation may also be conducted to improve a medicine’s formula.
Medicines already registered under Minister of Health Regulation No. 949/Menkes/Per/VI/2000 whose registration expires after the promulgation of Regulation 1010/2008 may have their registration extended for two years as of the date of the promulgation of Regulation 1010/2008. For registration applications submitted prior to the enactment of this Regulation, the provisions of Minister of Health Regulation No. 949/Menkes/Per/VI/2000 will still apply.