Registration of Medicines

Indonesia has a long history of fake medicines and drugs being sold from roadside stalls. The reality is that many Indonesians cannot afford even basic generic medicines, let alone branded medicines. Many opt to purchase their medicines from road side stalls where the quality and safety of medicines is questionable.

In an attempt to counter the risks and in order to protect the community from bad medicine the Minister of Health has issued Regulation No. 1010/MENKES/PER/XI/2008 on the Registration of Medicines. The Regulation is also designed to simply the provisions contained in Minister of Health Regulation No. 949/Menkes/Per/VI/2000 in light of expanding globalization and government policy.

The Regulation is explicit in stating that before a medicine can be distributed in Indonesia it must be registered. The Regulation lists the conditions for registration for:

-                 Domestically produced medicines;

-                 Narcotics;

-                 Contract medicines;

-                 Imported medicines;

-                 Exported medicines; and

-                 Patent-protected medicines.

The procedures for obtaining a distribution license are listed in the Regulation and include, among others, 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 a distribution license is issued that license will be valid for a period of five years and may be extended provided the license holder continues to meet the prevailing requirements for a license.

The sanctions available under the provisions of the Regulation are both administrative and criminal in nature. The criminal provisions are those that are contained in Law No. 23 of 1992 on Health. The administrative sanctions that are available under the provisions of this Regulation include the cancellation of distribution licenses.

For those medicines registered under Minister of Health Regulation No. 949/Menkes/Per/VI/2000 whose registration expires after the enactment of this Regulation may have their registrations extended for a period of two years from the date of enactment of this Regulation. 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 continue to apply.

This Regulation repeals and replaces Minister of Health Regulation No. 949/Menkes/Per/VI/2000.

The Regulation has been in force since 3 November 2008.