a. that to protect the public from the circulation of medicines which do not meet security, quality and utility requirements, it is necessary to assess the circulation of medicines through the registration of medicines;
b. that provisions on the registration of medicines provided for in Regulation of the Minister of Health No. 949/Menkes/Per/VI/2000 need to be simplified and adjusted to global developments and government policies:
c. that based on consideration in paragraphs a and b, it is necessary to regulate again the registration of medicines by Regulation of the Minister of Health.
1. Strong Medicine Ordinance (Statute Book No. 419/1949);
2. Law No. 23/1992 concerning Health (Statute Book of 1992 No. 100, Supplement to Statute Book No. 3495);
3. Law No. 5/1997 concerning Psychotropic (Statute Book No. 10/1997, Supplement to Statute Book No. 3671);
4. Law No. 22/1997 concerning Narcotics (Statute Book No. 67/1997, Supplement to Statute Book No. 3698);
5. Law No. 8/1999 concerning Consumer Protection (Statute Book of 1999, Supplement to Statute Book No. 3821);
6. Government Regulation No. 72/1998 concerning the Safeguarding of Pharmaceutical Preparations and Health Devices (Statute Book No. 138/1998, Supplement to Statute Book No. 3778);
7. Government Regulation No. 38/2007 concerning the Sharing of Administrative Affairs between the Government, Provincial Governments and Regency/Municipal Governments (Statute Book No. 82/2007, Supplement to Statute Book No. 4737);
8. Presidential Regulation No. 9/2005 concerning the Position, Task, Organizational Structure and Work Mechanism of State Ministries as amended several times, the latest by Presidential Regulation No. 94/2006;
9. Regulation of the Minister of Health No. 1575/Menkes/Per/XI/2005 on the Organizational Structure and Work Mechanism of the Health Ministry as has been amended by Regulation of the Minister of Health No. 1295/Menkes/Per/XIl/2007.
REGULATION OF THE MINISTER OF HEALTH CONCERNING THE REGISTRATION OF MEDICINES
In this Ministerial Regulation:
1. Circulation permit is a form of approval of the registration of medicines to be circulated in the Indonesian territory.
2 Medicine is a finished medicine which constitutes preparation or combination of substances including biological product and contraceptive which is used to influence or investigate a physiologic system or pathologic condition within the frame of diagnosis, prevention, cure, rehabilitation and health improvement.
3. Biological product is vaccine, immunizer, antigen, hormone, enzyme, blood product and other fermentation products (including monoclonal antibody and products originating from the DNA recombinant technology) which is used to influence or investigate a physiologic system or pathologic condition within the frame of prevention, cure, rehabilitation and health improvement.
4. Registration is the procedure of registering and evaluating medicines to obtain a circulation permit.
5. Contract medicine is a medicine whose manufacturing is delegated to other pharmaceutical industry.
6. Contract provider is the pharmaceutical industry which delegates the manufacture of medicines under a contract.
7. Contract recipient is the pharmaceutical industry which receives the manufacture of medicines under a contract.
8. Imported medicine is the medicine produced by foreign pharmaceutical industry.
9. Marking is complete information on the peculiar property, security, direction for use and other necessary information put in the etiquette, brochure and primary and secondary package accompanying the medicine.
10. Fake medicine is the medicine which is produced by an unauthorized party based on the existing law or medicine or marking imitates the identity of other medicine which already has a circulation permit.
11. Psychotropic is a substance or medicine, either natural or synthetic, which has psychoactive property through selective influence on the central nerve structure which leads to a typical change in the mental activity and behavior.
12. Narcotics is a substance or medicine which originates from plant or non plant material, either synthetic or semi synthetic, which can reduce or change consciousness, remove sense, reduce up to remove pain and cause addiction.
13. Circulation is an activity or a series of activities to distribute or deliver medicines, within the frame of trade, non trade or transfer.
14. Patent protected product is a product which is protected by patent based on the patent law prevailing in Indonesia.
15. Minister is the minister who is responsible for the health sector.
16. Head of the Board is the head of the board which is responsible for controlling medicines and foods.
(1) Medicines which are to be circulated in the Indonesian territory shall undergo prior registration to get a circulation permit;
(2) Circulation permits are issued by the Minister;
(3) The Minister delegates the authority to issue circulation permits to the head of the Board;
(4) Excepted from the provisions as intended in paragraph (1) are:
(1) The medicines as intended in Article 2 paragraph (4) can be taken into the Indonesian territory through the Mechanism of Special Lane.
(2) Provisions on the mechanism of special lane are stipulated by the Minister.
The medicines which have circulation permit shall meet the following criteria:
(1) Medicines for a clinical test shall prove that they are safe for human beings.
(2) Further provisions on the realization of clinical test are to be stipulated by the head of the body.
(1) The registration of locally made medicines is only done by pharmaceutical industries the: have secured a permit of pharmaceutical industry zm the Minister.
(2)The pharmaceutical industries as intended in paragraph (1) shall meet CPOB requirements.
(3)The fulfilment of the CPOB requirements as intended in paragraph (2) shall be proved by a CPOB certificate issued by the Head of the Board.
(1) The registration of narcotic medicines can only be done by pharmaceutical industries which have secured a special permit from the Minister to produce narcotic medicines.
(2) The pharmaceutical industries as intended in paragraph (1) must meet CPOB requirements.
(3) The fulfilment of the CPOB requirements as intended in paragraph (2) is proven by a CPOB certificate issued by the Head of the Board.
(1) The registration of contract medicines can only be done by contract providers by enclosing contract documents;
(2) The contract providers as intended in paragraph (1) are pharmaceutical industries;
(3) The pharmaceutical industries that provide contracts as intended in paragraph (2) shall hold a permit of pharmaceutical industry and have at least 1 (one) facility that meets CPOB requirements to produce other preparations.
(4) The pharmaceutical industries that provide contracts shall be responsible for the quality of finished medicines produced under a contract;
(5) Contract recipients are domestic pharmaceutical industries that must hold a permit of pharmaceutical industry and have applied CPOB for contracted preparations.
The importation of medicines shall give priority to medicines for public health programs, newly invented medicines and medicines that have not been produced at domestically.
(1) The registration of imported medicines is done by domestic pharmaceutical industries that have received written approval from overseas pharmaceutical industries.
(2) The written approval as intended in paragraph (1) shall cover transfer of technology with the stipulation that in no later than 5 (five) years the medicines can be produced at home.
(3) Excepted from provisions in paragraph (2) are patent protected medicines.
(4) The overseas pharmaceutical industries as intended in paragraph (1) shall meet CPOB requirements.
(5) The fulfilment of CPOB requirements by pharmaceutical industries as intended in paragraph (3) is proven by an appropriate document or if needed, an on the spot inspection can be conducted by an authorized officer.
(6) The document as intended in paragraph (5) must be complete with data on the latest inspection not more than 2 (two) years from the local authorized official.
(7) Provisions on procedure of on the spot inspection as intended in paragraph (4) are to be stipulated by the Head of the Board.
(1) The registration of export medicines is only done by pharmaceutical industries.
(2)The export medicines as intended in paragraph (1) shall meet the criteria as intended in Article 4 paragraphs a and b.
(3) Exception to the provisions as intended in paragraph (2) is given in case of written approval from the country of destination.
(1) The registration of patent protected medicines with quality substances in Indonesia is only done by domestic pharmaceutical industries as patent holders or other pharmaceutical industries appointed by the patent holders.
(2) The patent as intended in paragraph (1) shall be proven by a patent certificate.
(1) The registration of patent protected medicines with quality substances in Indonesia can be done by domestic pharmaceutical industries other than patent holders.
(2) The application for the registration as intended in paragraph (1) can be filed 2 (two) years before the expiry of patent protection.
(3) In case the registration as intended in paragraph (2) is approved the related medicines can only be circulated after the protection period of the patent of innovator medicines has expired.
(1) Any application for registration shall be filed to the Head of the Board.
(2) The criteria and procedures of registration are set by the Head of the Board.
(3) Registration documents constitute confidential documents used only for the purpose of evaluation by the authorized party.
(1) Registration is subject to fees;
(2) Provisions on fees as intended in paragraph (1) are set in accordance with the law and regulation;
Registration documents that have met provisions are evaluated in accordance with the criteria as intended in Article 4.
(1) To conduct evaluation the following bodies are set up:
(2) The formation, task and function of the National Committee for Medicine Evaluation and other committees as intended in paragraph (1) are set by the Head of the Board.
(1) The Head of the Board shall approve or reject any application for a circulation permit based on recommendations from the National Committee for Medicine Evaluation, the Committee for Quality and Security Evaluation and the Committee for Quality Evaluation, Technology, Marking and Medicine Rationality;
(2) The Head of the Board shall report the circulation permit as intended in paragraph (1) to the Minister once every year;
(3) In case an application for the registration of medicines is rejected, the cost as intended in Article 15 paragraph (1) can not be refunded.
(1) In case an application for registration is rejected the applicant can file objection through the procedure of review;
(2) The procedure of filing a request for review as intended in paragraph (1) is set by the Head of the Board.
A circulation permit shall be valid for 5 (five) years and can be extended as long as it meets the existing provisions.
(1) An applicant for registration that has secured a circulation permit shall produce or import and circulate medicines no later than 1 (one) year after the date of approval.
(2) The implementation of provisions in paragraph (1) shall be reported to the Head of the Board.
(1) Medicines that have received a circulation permit can be re-evaluated.
(2) The re-evaluation of medicines that have been in circulation applies to:
(3) In case medicines as intended in paragraph (2) are re-evaluated, pharmaceutical industries shall withdraw the medicines from circulation.
(4) Re-evaluation is also conducted to improve the composition and formula of medicines.
Without abridging criminal penalty as arranged in Law No. 23/1992 concerning Health, the Head of the Board can impose administrative sanction in the form of cancelling circulation permits if one of the following matters occurs:
(1) Applications that have been filed and met registration documents before this Regulation takes effect will constantly be processed in accordance with Regulation of the Minister of Health No. 949/MENKES/PER/VI/2000 concerning the Registration of Finished Medicines;
(2) The circulation permits of medicines that have been issued based on Regulation of the Minister of Health No. 949/MENKES/PER/VI/2000 concerning the Registration of Finished Medicines and have expired after the stipulation of this Regulation can be extended for another 2 (two) years at the most after the stipulation of this Regulation.
All provisions on the procedures of registering finished medicines that have been issued before the stipulation of this Regulation shall remain valid, provided they do not run counter to this Regulation.
When this Regulation takes effect, Regulation of the Minister of Health No. 949/MENKES/PER/VI/2000 concerning the Registration of Finished Medicines shall be declared null and void.
This Regulation shall come into force as from the date of stipulation.
For public cognizance, this Regulation shall be promulgated by placing it in the State Gazette of the Republic of Indonesia.
Stipulated in Jakarta
on November 3, 2008
THE MINISTER OF HEALTH,
signed,
Dr. dr. SITI FADILAH SUPARI, Sp. JP (K)