DECREE OF THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA
No. PO.00.04.5.00327

ON
FORM AND PROCEDURES OF AFFIXATION OF
REGISTRATION STICKER ON FOREIGN TRADITIONAL DRUG

THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA,

Considering:

• a. That, recently, numerous fake and dark foreign traditional drugs have been circulating, so that, in addition to not complying validity requirement, they are also doubtful in its safety, usefulness and quality;
• b. That in order to protect the community from foreign traditional drugs that do not comply with medical requirements, it is necessary to distinguish between fake or dark foreign traditional drugs and registered foreign traditional drugs;
• c. That in order to give distinguisher as contemplated in item b, it is necessary to affix registration stickers on the containers and or packages;
• d. That in order to implement the affixation of registration stickers as contemplated in item c, it is necessary to stipulate form and procedures of affixation of registration sticker on foreign traditional drug.

In view of :

• 1. Law of the Republic of Indonesia No. 23/1992 on Health (Statute Book RI of 1992 No. 100; Supplement to Statute Book RI No. 3495);
• 2. Regulation of the Minister of Health RI No. 246/Menkes/Per/V/1990 on Traditional Drug Industrial Business License and Traditional Drug Registration.

DECIDES

To stipulate :

DECREE OF THE MINISTER OF HEALTH ON FORM AND PROCEDURES OF AFFIXATION OF REGISTRATION STICKER ON FOREIGN TRADITIONAL DRUG

First :

To ratify and enact Form and Procedures of Affixation of Registration Sticker on Foreign Traditional Drugs, as specified in the attachment to this Decree.

Second :

Foreign traditional drugs which have been registered but not yet produced in Indonesia and or not yet affixed with marking in accordance with Regulation of the Minister of Health RI No. 246/Menkes/Per/l990 on Traditional Drug Industrial Business License, must be given with registration sticker issued by the Ministry of Health

Third :

Foreign Traditional Drugs that have not met provisions in the secondly dictum must be withdrawn from circulation.

Fourth :

Foreign Traditional Drugs which have not been registered must be re-exported or abolished in accordance with the prevailing statutory regulations.

Fifth :

Foreign Traditional Drugs which have been registered can be circulated again after having their markings been repaired.

Sixth :

Form and procedures of affixation of registration sticker for foreign traditional drugs as contemplated in firstly dictum may be subjected review and restipulation by the Director General of Drug and Food Control on behalf of the Minister of Health.

Seventh :

Matters that are not adequately provided for in this decree shall be regulated further by the Director General of Drug and Food Control.

Eighth :

This decree comes to effect as of the stipulation date. Businesses in traditional drug sector are given with an opportunity to withdraw their foreign traditional drugs as contemplated in thirdly dictum not later than 6 months as of this decree is stipulated.

Stipulated in Jakarta
on February 10, l994

THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA
THE DIRECTOR GENERAL OF DRUG AND FOOD CONTROL
Sgd.
DRS. SLAMET SUSILO