GOVERNMENT REGULATION ON THE SAFEGUARDING OF PHARMACEUTICAL PREPARATION AND MEDICAL DEVICES
As used in this government regulation :
(1) Pharmaceutical preparation and medical devices to be produced and/or circulated must comply with the quality, safety, and efficacy requirements,
(2) Quality, safety, and efficacy requirements as meant in paragraph (1) for:
Pharmaceutical preparation and medical devices shall only be produced by business entities that fulfilled the industrial business licence in accordance with the prevailing statutory regulations.
(1) Provision as meant in Article 3 is not applicable anymore to a pharmaceutical preparation that takes the from of traditional drug produced by individual.
(2) Further provisions regarding with production of pharmaceutical preparation that takes the form of traditional drug by individual is regulated by the Minister.
(1) Production of pharmaceutical preparation and medical devices must be conducted by means of good production method.
(2) Good production method as meant in paragraph (1) shall be stipulated by the Minister.
Circulation of pharmaceutical preparation and medical devices consists of distribution and delivery.
Circulation of pharmaceutical preparation and medical devices shall be conducted by considering the efforts of maintaining quality of pharmaceutical preparation and medical devices.
(1) Any transportation of pharmaceutical preparation and medical devices in the framework of circulation must be accompanied with documents of transportation of pharmaceutical preparation and medical devices.
(2) Any forwarder of pharmaceutical preparation and medical devices in the framework of circulation shall be responsible for the completeness of documents of transportation of pharmaceutical preparation and medical devices.
(1) Pharmaceutical preparation and medical devices can only be circulated after obtaining circulation licence from the Minister.
(2) Excluded from the provision as meant in paragraph (1) are pharmaceutical preparations that take the form of traditional drug produced by individual persons.
(1) Circulation licence of pharmaceutical preparation and medical devices is given based on written application to the Minister.
(2) Written application as meant in paragraph (1) shall be accompanied with information and/or data on pharmaceutical preparation and medical devices applied for to obtain the circulation licence and sample of pharmaceutical preparation and medical devices.
(3) Further provisions concerning procedure of application for circulation licence as meant in paragraph (1) and paragraph (2) by the Minister.
Pharmaceutical preparation and medical devices for which the circulation licence is applied shall be proper in term of quality, safety and efficacy.
(1) Testing of pharmaceutical preparation and medical devices shall be conducted through:
(2) Procedure to test the preparation and medical devices as meant in paragraph (1) is stipulated by the Minister.
(1) Circulation licence is issued to the pharmaceutical preparation and medical devices that pass the test
(2) Circulation licence as meant in paragraph (1) is issued in the form of registration approval.
(3) A statement letter is issue to the pharmaceutical preparation and medical devices that do not pass the test, stating that the relevant pharmaceutical preparation and medical devices do not comply with the requirements for circulation.
(4) Further provisions on the circulation licence and the statement letter as meant in paragraphs (1), (2), and (3) above are regulated by the Minister.
(1) The Minister shall keep confidential any information and/or data of pharmaceutical preparation and medical devices submitted and the results of pharmaceutical preparation and medical device tests.
(2) Implementation of the provision as meant in paragraph (1) is regulated further by the Minister with due observance to prevailing statutory regulations.
(1) Distribution of pharmaceutical preparation and medical devices can only be conducted by:
(2) Provisions as meant in paragraph (1) are excluded for individual person who distributes pharmaceutical preparation that takes the form of traditional drug and cosmetic with limited quantity of commodity and/or traded directly to the community.
(3) Further provision concerning procedures of distribution of pharmaceutical preparation and medical devices as meant in paragraph (1) and paragraph (2) is regulated by the Minister.
(1) Delivery of pharmaceutical preparation and medical devices shall be conducted for use in health services or for scientific interest.
(2) Delivery of pharmaceutical preparation and medical devices for use in health services shall be conducted based on:
(3) Further provisions concerning delivery of pharmaceutical preparation and medical devices as meant in paragraph (1) and paragraph (2) are regulated by the Minister.
Pharmaceutical preparation and medical devices to be imported into and exported from Indonesian territory for circulation must comply with the quality, safety and efficacy requirements.
(1) Import and export of pharmaceutical preparation and medical devices into and from Indonesian territory can only be conducted by business entities that have licence as importer and/or exporter in accordance with the prevailing statutory regulations.
(2) In addition to licence as importer and/or exporter, business entities as meant in paragraph (1) must posses Permit of the Minister in accordance with the prevailing statutory regulations for importation and exportation of pharmaceutical preparation that takes the form of drug ingredients and drug into and from Indonesian territory.
(1) In addition to provisions meant in article 18, research institutions and/or educational institutions can import pharmaceutical preparation and medical devices into Indonesian territory for scientific interest.
(2) Research institutions and/or educational institutions as meant in paragraph (1) are prohibited to circulate pharmaceutical preparation and medical devices.
(1) Pharmaceutical preparation and medical devices to be imported and exported into and from Indonesian territory for circulation must be furnished with document stating that the relevant pharmaceutical preparation and medical devices have passed the testing in term of quality, safety and efficacy from the competent authority in its country of origin or the Minister.
(2) Furnishing of the test result document as meant in paragraph (1) shall be liability of the importer and/or exporter of pharmaceutical preparation and medical devices.
Any transportation in the framework of import and export of pharmaceutical preparation and medical devices into and from Indonesian territory shall be conducted with due observance to the efforts of quality maintenance of pharmaceutical preparation and medical devices.
(1) Pharmaceutical preparation and medical devices to be imported into Indonesian territory for circulation must possess circulation licence from the Minister.
(2) Procedures to obtain circulation licence for pharmaceutical preparation and medical devices to be imported into Indonesian territory, shall be conducted in accordance with provisions on circulation licence of pharmaceutical preparation and medical devices.
(1) As to pharmaceutical preparations that take the form of drug that are highly needed in health services and not produced yet in Indonesia, can be imported into the Indonesian territory in addition to by importers as meant in Article 18.
(2) Import of pharmaceutical preparation that takes the form of drug as meant in paragraph (1) shall only be conducted for:
(3) Importation of pharmaceutical preparation that takes the form of drug as meant in paragraph (1) and paragraph (2) shall be conducted with due observance to quality, safety and efficacy requirements.
(4) Implementation of provision as meant in paragraphs (1), (2) and (3) above shall be regulated further by the Minister.
(1) Pharmaceutical preparation and medical devices shall be packed by using packing materials that are not harmful to the human health and/or able to affect the change in quality, safety and efficacy requirements of pharmaceutical preparation and medical devices.
(2) Further provisions concerning packaging of pharmaceutical preparation and medical devices as meant in paragraph (1) is regulated by the Minister.
(1) Pharmaceutical preparation and medical devices with damaged packing that directly contact with the product of pharmaceutical preparation and medical devices, are prohibited for circulation.
(2) Pharmaceutical preparation and medical devices as meant in paragraph (1) shall be destroyed in accordance with the provision concerning destruction of pharmaceutical preparation and medical devices.
(1) Marking and information of pharmaceutical preparation and medical devices is conducted to protect the community from medical devices that are not objective, incomplete and misleading.
(2) Marking and information of preparation and medical devices can take the form of pictures, colours, writings or combination of them or other forms that are furnished on the packing or inserted into the packing, or constitutes a part of the container and/or its packing.
Business entities circulating pharmaceutical preparation and medical devices must mention marking and information of pharmaceutical preparation and medical devices.
(1) Marking and information of pharmaceutical preparation and medical devices to be included as meant in Article 27 must comply with the requirements in the form of writings that contain information on pharmaceutical preparation and medical devices objectively, completely and misleading.
(2) Information as meant in paragraph (1) shall at least contain:
(3) Further provisions concerning marking and information to be included as meant in paragraph (1) and paragraph (2) are regulated by the Minister.
Any additional information other than as determined in the provision as meant in Article 28, can only be included if they are consistent with information specified in the circulation licence of pharmaceutical preparation and medical devices.
(1) Provision concerning the marking and information of pharmaceutical preparation and medical devices provided for in this Government Regulation is not applicable to pharmaceutical preparation that takes the form of traditional drug produced by individual persons.
(2) The Minister shall conduct fostering relating to marking and information of pharmaceutical preparation that takes the form of traditional drug produced by individual persons.
Advertisement of pharmaceutical preparation and medical devices to be circulated must contain objective, complete and non-misleading information concerning the pharmaceutical preparation and medical devices.
Pharmaceutical preparation that takes the form of drug for health service the delivery of which is based on medical prescription can only be advertised in medical scientific print media or pharmaceutical scientific print media.
Advertisement concerning pharmaceutical preparation and medical devices in any advertising media shall be conducted with due observance to the advertising ethics.
(1) In order to secure pharmaceutical preparation and medical devices that meet quality, safety and efficacy requirements, efforts of maintaining quality of pharmaceutical preparation and medical devices shall be made.
(2) The efforts of maintaining quality of pharmaceutical preparation and medical devices as meant in paragraph (1) shall be made from the production to circulation of the pharmaceutical preparation and medical devices.
(1) In the framework of implementation of the efforts of maintaining quality of pharmaceutical preparation and medical devices, the Minister conducts:
(2) Implementation of provision as meant in paragraph (1) shall be regulated further by the Minister.
In order to protect the community from dangers resulting from the use of pharmaceutical preparation and medical devices that do not comply with the quality, safety and efficacy requirements, retesting of pharmaceutical preparation and medical devices to be circulated is conducted.
Retesting of pharmaceutical preparation and medical devices to be circulated is conducted by the Minister.
Retesting of pharmaceutical preparation and medical devices to be circulated shall be conducted :
(1) If the result of retesting of pharmaceutical preparation and medical devices shows that the relevant pharmaceutical preparation and medical device does not meet the quality, safety and efficacy requirements or may result in health danger to human, then the circulation licence of relevant pharmaceutical preparation and medical devices is revoked.
(2) Further provisions concerning procedures of revocation of circulation licence as meant in paragraph (1) is regulated by the Minister.
(1) Pharmaceutical preparation and medical devices that have its circulation licence revoked due to provisions as meant in Article 39 paragraph (1), are prohibited to be produced in or imported into Indonesian territory for circulation.
(2) Pharmaceutical preparation and medical devices that have its circulation licence revoked as meant in paragraph (1) shall be withdrawn from circulation for destruction.
(1) Withdrawal of pharmaceutical preparation and medical devices from circulation due to its circulation licence revoked, shall be conducted by and become liability of the business entity that produces and/or circulates the pharmaceutical preparation and medical devices.
(2) Further provision concerning procedure of withdrawal of pharmaceutical preparation and medical devices and circulation as meant in paragraph (1) is regulated by the Minister.
(1) The minister disseminates information to the public community relating to the pharmaceutical preparation and medical devices being withdrawn from the circulation.
(2) Further provisions concerning dissemination of information to the community as meant in paragraph (1) above is regulated by the Minister.
(1) Any person shall have the right to receive compensation if the pharmaceutical preparation and medical devices he/she uses results in the health disturbance, disability or death that occurs from the pharmaceutical preparation and medical devices that does not meet the quality, safety and efficacy requirements.
(2) Compensation as meant in paragraph (1) shall be implemented in accordance with the prevailing statutory regulations.
Destruction of pharmaceutical preparation and medical devices shall be conducted to pharmaceutical preparation and medical devices that is:
(1) Destruction of pharmaceutical preparation and medical devices shall be conducted by business entity that produces and/or circulates the pharmaceutical preparation and medical devices, and/or person who is responsible for the health facility and/or the government.
(2) Destruction of pharmaceutical preparation and medical devices that is related with the criminal offence in the filed of pharmaceutical preparation and medical devices shall be conducted by the government in accordance with the prevailing statutory regulations.
Destruction of pharmaceutical preparation and medical devices shall be conduced by paying attention its effects to human health and the efforts of living environment conservation.
(1) Destruction of pharmaceutical preparation and medical devices must be reported to the Minister.
(2) Report of destruction of pharmaceutical preparation and medical devices as meant in paragraph (1) shall contain at least:
(3) Report of destruction of pharmaceutical preparation and medical devices as meant in paragraph (2) shall be signed by the person responsible and the witness in the implementation of destruction of pharmaceutical preparation and medical devices.
Further provisions concerning procedure of destruction and reporting of pharmaceutical preparation and medical devices as meant in Article 44, Article 45, Article 46 and Article 47 are regulated by the Minister.
The community has the opportunity to participate widely in realizing the protection to the community from any dangers resulting from the use of pharmaceutical preparation and medical device that is improper and/or not compliant with the quality, safety and efficacy requirements.
The community participation shall be aimed to improve and empower the existing ability of the community in the framework of safeguarding of pharmaceutical preparation and medical devices.
The community participation shall be conducted through:
The community participation can be conducted by individual, group, or legal entity operated by the community.
(1) In the framework of increasing community participation, the Minister disseminates information and understanding related to the community participation in safeguarding the pharmaceutical preparation and medical devices.
(2) Implementation of provision as meant in paragraph (1) is regulated further by the Minister.
The Minister conducts fostering to all activities relating with the safeguarding of pharmaceutical preparation and medical devices.
(1) Fostering by the Minister as meant in Article 54 is aimed at :
(2) Fostering as meant in paragraph (1) shall be conducted in the fields of :
(1) Fostering in the field of information as meant in Article 55 letter a shall be conducted by means of :
(2) In order to protect the community as meant in paragraph (1) letter b, the Minister stipulates guidelines of advertisement material content of pharmaceutical preparation and medical devices.
(3) Stipulation of guidelines of advertisement material content as meant in paragraph (2) is conducted with due observance to considerations of the Minister in charge of information sector.
Fostering in the field of production as meant in Article 55 letter b shall be conducted by means of :
Fostering in the field of circulation as meant in Article 55 letter c shall be conducted by means of :
Fostering in the field of human resources as meant in Article 55 letter d shall be conducted by means of :
Fostering in the field of health service as meant in Article 55 letter e shall be conducted by means of:
(1) In the framework of fostering, the Minister makes efforts of increasing the use of pharmaceutical preparation that takes the form of generic drug in the health services
(2) Efforts as meant in paragraph (1) shall be made by means of:
(3) In the framework of health service, replacement of pharmaceutical preparation that takes the form of drug based on medical prescription with its equivalence in the form of generic drug, can be conducted upon approval of the prescribing doctor and shall be carried out in consideration to the economic ability of the health service receiver.
(4) Implementation of provision as meant in paragraph (1), paragraph (2) and paragraph (3) is regulated further by the Minister.
In the framework of fostering, the Minister may establish International cooperation in the field of safeguarding of pharmaceutical preparation and medical devices in accordance with the national interest.
In the framework of fostering, the Minister may grant award to persons who or entities that are meritorious in assisting the implementation of safeguarding pharmaceutical preparation and medical devices.
Inspection to all activities that relate to the safeguarding of pharmaceutical preparation and medical devices is conducted by the Minister.
In implementing inspection, the Minister appoints inspectors who are in charge of conducting inspection in the field of safeguarding of pharmaceutical preparation and medical devices.
In performing task as meant in Article 65, the inspectors conduct the following functions :
In performing their tasks and functions, the inspectors are equipped with :
(1) Identity as meant in Article 67 letter a contains :
(2) Certificate as meant in paragraph (1) letter b is completed with photograph of the relevant inspector and signed by the competent authority who is appointed by the Minister.
(1) Instruction letter of inspection as meant in Article 67 letter b at least contains :
(2) Instruction letter of inspection as meant in paragraph (1) is signed by the competent authority appointed by the Minister.
Anyone who is responsible for the place that is inspected by the inspectors shall have the right to refuse the inspection is the relevant inspectors are not equipped with identity and instruction letter of inspection.
If the result of inspection by the inspectors reveals any indication or allegedly indication of law violation in the field of pharmaceutical preparation and medical devices, investigation shall be conducted immediately by the competent investigator in accordance with the prevailing statutory regulations.
(1) The Minister can take administrative action to the health facility and health personnel who violate the law in the field of pharmaceutical preparation and medical devices.
(2) Administrative action as meant in paragraph (1) can take the form of :
(3) Administrative action in the form of temporary revocation or permanent revocation of licence as meant in paragraph (2) shall be conducted by the Minister or another competent Minister.
(4) Further provisions concerning procedure of administrative action taking as meant in paragraphs (1), (2), and (3) above are regulated by the Minister and/or another Minister either jointly or severally in accordance with their respective scope of duty.
(1) If the law violation is committed by health personnel, the administrative action shall be taken by the Minister in the form of:
(2) The taking of administrative action against health personnel as meant in paragraph (1) shall be conducted with due observance to the prevailing statutory regulations.
Anyone who purposely produces and/or circulates pharmaceutical preparation in the form of drug or drug ingredients that do not comply with requirements as meant in Article 2 paragraph (1) and paragraph (2) letter a, shall be punished with imprisonment of maximum 15 (fifteen) years and fines of maximum Rp.300.000.000,- (three hundred million rupiah) in accordance with provision in Article 80 paragraph (4) of Law Number 23 of 1992 on Health.
Anyone who purposely:
Anyone who purposely:
Anyone who purposely circulates pharmaceutical preparation and medical devices without mentioning marking and information as meant in Article 27 and Article 28, shall be punished with imprisonment of maximum 5 (five) years and/or fines of maximum Rp. 100.000.000,00 (one hundred million rupiah) in accordance with provision in Article 82 paragraph (2) of Law No. 23/1992 on Health.
Based on provision in Article 83 of Law No. 23/1992 on Health, the threatened punishment as meant in Article 74, Article 75, Article 76 and Article 77, shall be increased by a fourth if resulting in major injury or a third if resulting in death.
Based on provision in article 86 of Law Number: 23 of 1992 on Health, anyone who purposely :
Efforts of safeguarding of pharmaceutical preparation that takes the form of prescription drugs, as long as not yet regulated in any implementing regulations of Ordinance of Prescription Drug, shall be conducted based on safeguarding of pharmaceutical preparation and medical devices as meant in this Government Regulation.
With the enforcement of this Government Regulation, all of the existing statutory regulations relating to pharmaceutical preparation and medical devices, shall remain be effective as long as not contradictory to and or not yet amended by this Government Regulation.
With enactment of this Government Regulation, then :
Government Regulation comes into force as from the date of promulgation.
For public cognizance, this Government Regulation shall be promulgated by placing it in Statute Book of the Republic of Indonesia.
Stipulated in Jakarta
On September 16, 1998
THE PRESIDENT OF THE REPUBLIC OF INDONESIA,
sgd
BACHARUDDIN JUSUF HABIBIE
Promulgated in Jakarta
On September 16, 1998
THE SECRETARY OF THE STATE OF THE REPUBLIC OF INDONESIA,
sgd
AKBAR TANJUNG