The Minister of Health has issued Regulation No. 1010/MENKES/PER/XI/2008 on the Registration of Medicines which simplifies the previous provisions contained in the Minister of Health Regulation No.949/Menkes/Per/IV/2000. The regulation is issued to counter the risks of bad medicine and to protect the community.

The regulation prescribes that a medicine that will be distributed in Indonesia should be registered first. Moreover, the regulation lists the conditions for registration of domestically produced medicines, narcotics, contract medicines, imported medicines, exported medicines, and patent-protected medicines.

The procedures to obtain such license can be done by submitting the application to the relevant Agency Head and any confidential documents required for evaluation. The evaluation will be undertaken by a specially established National Committee for Medicine Evaluation, a Committee for Safety Evaluation, and a Committee for Medicine Quality. Once the license is being issued, it will be valid for five years and may be extended provided that the license holder continues to meet the prevailing requirements for a license.

Non compliance to the rules prescribed in the regulation may be subject to administrative and criminal sanction. For Medicine that has been registered under Minister of Health Regulation No.949/Menkes/Per/IV/2000 may have their registration expiration extended for a period of two years from the date of enactment of this regulation. 

Source: www.hukumonline.com, ILB 11/11/2008: Registration of Medicines