to Indonesian
a. that comprehensive regulation on the Pharmaceutical Industry is needed to anticipate the implementation of the international trade in the field of pharmaceutical;
b. that Decree of the Minister of Health Decree No. 245/Menkes/SK/X/1990 concerning Provisions and Implementation Procedures on the Granting Pharmaceutical Industry Business Permit is not in appropriate with the development of science and technology;
c. that based on considerations as intended in paragraphs a and b, it is necessary to stipulate Regulation of the Minister of Health concerning Pharmaceutical Industry;
1. Prescription Drugs Ordinance (Statute Book No. 419 of 1949);
2. Law No. 5 of 1984 concerning Industry (Statute Book of the Republic of Indonesia No. 22 of 1984, Supplement to Statute Book of the Republic of Indonesia No. 3274);
3. Law No. 5 of 1997 concerning Psychotropic (Statute Book of the Republic of Indonesia No. 10 of 1997, Supplement to Statute Book of the Republic of Indonesia No. 3671);
4. Law No. 8 of 1999 concerning Consumer Protection (Statute Book of the Republic of Indonesia No. 42 of 1999, Supplement to Statute Book of the Republic of Indonesia No. 3821);
5. Law No. 32 of 2004 concerning Regional Government (Statute Book of the Republic of Indonesia No. 125 of 2004, Supplement to Statute Book of the Republic of Indonesia No. 4437) as amended several times, the latest by Law No. 12 of 2008 concerning the Second Amendment to Law No. 32 of 2004 concerning Regional Government (Statute Book of the Republic of Indonesia No. 59 of 2008, Supplement to Statute Book of the Republic of Indonesia No. 4844);
6. Law No. 35 of 2009 concerning Narcotics (Statute Book of the Republic of Indonesia No. 143 of 2009, Supplement to the Republic of Indonesia No. 5062);
7. Law No. 36 of 2009 concerning Health (Statute Book of the Republic of Indonesia No. 144 of 2009, Supplement to Statute Book of the Republic of Indonesia No. 5063);
8. Government Regulation No. 17 of 1986 concerning the Authority for Industrial Management, Fostering and Development (Statute Book of the Republic of Indonesia No. 23 of 1986, Supplement to Statute Book of the Republic of Indonesia No. 3330);
9. Government Regulation No. 13 of 1995 concerning Industrial Business Permit (Statute Book of the Republic of Indonesia No. 25 of 1995, Supplement to Statute Book of the Republic of Indonesia No. 3596);
10. Government Regulation No. 72 of 1998 concerning Safety of Pharmaceutical Preparation and Medical Devices (Statute Book of the Republic of Indonesia No. 138 of 1998, Supplement to Statute Book of the Republic of Indonesia No. 3781);
11. Government Regulation No. 13 of 2009 concerning Types and Rates of Non Tax State Revenues Applicable at the Ministry of Health (Statute Book of the Republic of Indonesia No. 26 of 2009, Supplement to Statute Book of the Republic of Indonesia No. 4975);
12. Government Regulation No. 51 of 2009 concerning Pharmaceutical Works (Statute Book of the Republic of Indonesia No. 124 of 2009, Supplement to Statute Book of the Republic of Indonesia No. 5044);
13. Government Regulation No. 44 of 2010 concerning Precursors (Statute Book of the Republic of Indonesia No. 60 of 2010, Supplement to Statute Book of the Republic of Indonesia No. 5126);
14. Presidential Decree No. 16 of 1987 concerning the Simplification of Industrial Business Permit;
15. Presidential Decree No. 103 of 2001 concerning the Status, Duties, Functions, Authority, Organizational Structure, and Work Flow of Non Ministerial Government Institutions as amended several times, the latest by Presidential Decree No. 64 of 2005 concerning the Sixth Amendment on the Presidential Decree No. 103 of 2001 concerning the Status, Duties, Functions, Authority, Organizational Structure, and Work Flow of Non Ministerial Government Institutions;
16. Presidential Regulation No. 24 of 2010 concerning the Status, Duties, and Functions of the State Ministries and Organizational Structure, Duties, and Functions of Echelon I of State Ministries;
17. Regulation of the Minister of Health No. 1144/Menkes/Per/VIII/2010 concerning Organization and Work Flow of Ministry of Health;
REGULATION OF THE MINISTER OF HEALTH CONCERNING THE PHARMACEUTICAL INDUSTRY.
In this Regulation:
1. Drugs are substances or a combination of substances, including biological products that are used to influence or to investigate physiological systems or pathological conditions in the framework to decide diagnosis, prevention, healing, restoration, improvement of health and contraception, to human beings.
2. The drug substances are efficacious or not efficacious substances that are used in the drug processing with quality and standard as pharmaceutical raw substances.
3. Pharmaceutical Industry is a business entity that has a permit from the Minister of Health to conduct the manufacture of drugs or drug substances.
4. Making drug is all stages in producing the drug, which include procurement of starting substances and packaging materials, production, packaging, quality control, and quality assurance to obtain the drug to be distributed.
5. Good Drug Production Procedure hereinafter abbreviated as CPOB is ways of making drugs that aim to ensure the quality of medicines produced in accordance with the requirements and intended use.
6. Pharmacovigilance is all activities concerning the detection, assessment, understanding, and prevention of adverse effects or other problems associated with drug use.
7. Head of the Drug and Food Controller Agency hereinafter called as Head of Agency is the Head of Agency who has the duties and responsibilities in the field of drug and food controller.
8. Director General is the Director General of the Ministry of Health who has duties and responsibilities in the field of pharmaceutical and medical devices fostering.
9. Minister is the minister who held government affairs in the field of health.
(1) The process of producing of drugs and/or drug substance can only be done by the Pharmaceutical Industry.
(2) In addition to the Pharmaceutical Industry as intended in paragraph (1), Hospital Pharmacy Installation can do the process of drug producing for the purposes of the implementation of health services at the hospital.
(3) Hospital Pharmacy Installation as intended in paragraph (2) must first meet the requirements of CPOB, evidenced by a certificate of CPOB.
(1) Pharmaceutical Industry may engage in the producing of drugs and/or drug substances to:
(2) Pharmaceutical Industry conducting drug and/or drug substance manufacturing process to some of the stages as intended in paragraph (1) b shall be based on the research and development related to the product as a result of development in science and technology.
(3) Research and development result product as intended in paragraph (2) may do at some manufacturing process stages by the Pharmaceutical Industry in Indonesia.
(1) Every establishment of Pharmaceutical Industry must obtain pharmaceutical industry permit from the Director General.
(2) Pharmaceutical industry makes drugs and/or drug substances that are included in the class of narcotics must obtain special permit to produce narcotics in accordance with the provisions of the regulation.
(1) The requirements to obtain pharmaceutical industry permit as intended in Article 4 paragraph (1) consist of:
(2) Excluded from the requirements as intended in paragraphs (1) a and b, the applicant of pharmaceutical industry permit owned by Indonesian National Army and Police of the Republic of Indonesia.
(1) To obtain the pharmaceutical industry permit is required principle permit.
(2) The application for principle permit as intended in paragraph (1) shall be submitted in writing to the Director General.
(3) In case the application for principle permit by the industry of Foreign Investment or Domestic Investment, the applicant must obtain a Letter of Investment Approval from the institution who organizing the affairs of the investment in accordance with regulations.
(4) Principle permit as intended in paragraph (1) is given by the Director General after the applicant received approval of Development Master Plan (RIP) from Head of Agency.
(5) In case the application for principle permit has been obtained, the applicant may directly undertake the preparation, development, supply, installation of equipment, including trial production by considering to the provisions of the regulations.
Each establishment of the Pharmaceutical Industry must comply with provisions as governed by regulations in the field of spatial planning and the environment.
(1) Pharmaceutical Industry must meet CPOB requirements.
(2) Compliance with CPOB requirements as intended in paragraph (1) as evidenced by a certificate of CPOB.
(3) CPOB certificate is valid for 5 (five) years while it meets the requirements.
(4) Further provisions on the conditions and procedures for the certification of CPOB are governed by the Head of Agency.
(1) In addition shall comply with the provisions as intended in Article 8 paragraph (1), Pharmaceutical Industry shall conduct pharmacovigilance.
(2) If in conducting pharmacovigilance as intended in paragraph (1) Pharmaceutical industry find drugs and/or drug substances of their products that do not meet standards and/or requirements of safety, efficacy/benefit, and quality, the Pharmaceutical Industry shall report the matter to the Head of Agency.
(3) Further provisions on the pharmacovigilance will be governed by the Head of Agency.
(1) Production of radiopharmaceutical preparations can only be done by the Pharmaceutical Industry and/or institution after obtaining consideration from the competent authorities in the field of atom.
(2) Production as intended in paragraph (1) shall meet the requirements of CPOB.
(3) Further provisions on the production of radiopharmaceutical preparations regulated by the Minister.
(1) Application for Principle permit submitted to the Director General with a copy to the Head of Agency and head of the provincial health department by using the sample as listed in attached Form 1.
(2) Prior to submission of an application for Principle permit as intended in paragraph (1), the applicant shall apply for approval of the Development Master Plan (RIP) to the Head of the Agency by using the sample as listed in attached Form 2.
(3) Approval of the Master Development Plan (RIP) is given by the Head of Agency at the latest of 14 (fourteen) working days after the application as intended in paragraph (2) received by using the sample as listed in Form 3 attached.
(4) The application for Principle permit as intended in paragraph (1) shall be filed with the following completeness:
(5) Principle permit granted by the Director General at the latest within 14 (fourteen) working days after the application as intended in paragraph (1) is received by using the sample as listed in attached Form 4 or reject it by using the sample as stated in attached Form 5.
(6) Application for pharmaceutical industry permit with the status of Foreign Investment or Domestic Investment which has received a Letter of Investment Approval from the agency in the field of investment affairs shall apply for principle permit in accordance with the provisions of this Article.
(1) Principle permit valid for 3 (three) years.
(2) Principle permit can be changed by request of the applicant of the pharmaceutical industry.
(3) In certain cases related to the implementation of the completion of physical development, at the request of the applicant, the period of 3 (three) years as intended in paragraph (1) may be extended by the Director General for a maximum of 1 (one) year.
(4) When the applicant for pharmaceutical industry started doing physical development, it may submit a letter of application to import machinery and other equipment, including pollution control equipment in accordance with regulations.
(5) For carrying out physical development, it shall submit a report on the progress of the physical development every 6 (six) months to the Director General with a copy to the Head of Agency and the head of provincial health department by using the sample as listed in attached Form 6.
(6) Principle permit will not valid if after a period of 3 (three) years as intended in paragraph (1) and/or after a period of 1 (one) year extension as intended in paragraph (3), the applicant has not completed the physical development, with consider to the provision as intended in paragraph (5).
(1) Applicants who have completed the stage of principle permit as intended in Article 12 may apply for a pharmaceutical industry permit.
(2) The application for pharmaceutical industry permit must be signed by the managing director and pharmacists responsible for quality assurance with the following completeness:
(3) Application for pharmaceutical industry permit as intended in paragraph (1) shall be submitted to the Director General with a copy to the Head of Agency and the Head of local Provincial Health Agency by using the sample as listed in the attached Form 7.
(4) At the latest in 20 (twenty) days from receipt of copy of the application as intended in paragraph (3), Head of Agency shall audit CPOB compliance.
(5) At the latest in 20 (twenty) days from receipt of copy of the application as intended in paragraph (3), head of the provincial health department shall verify completion of administrative requirements.
(6) At the latest in 10 (ten) working days since comply with the requirements of CPOB, Head of Agency shall issue recommendation on the CPOB compliance to the Director General with a copy to the head of the provincial health department and the applicant, by using the sample as listed in the attached Form 8.
(7) At the latest in 10 (ten) working days since comply with administrative requirements, the head of provincial health department shall issue an administrative compliance recommendations to the Director General with a copy to the Head of the Agency and the applicant, by using the sample as listed in the attached Form 9.
(8) At the latest in 10 (ten) working days from receipt of the recommendation as intended in paragraphs (6) and (7) as well as other requirements, the Director General shall issue pharmaceutical industry permit by using the sample as listed in attached Form 10.
(1) Any application for Principle permit as intended in Article 6 paragraph (2), granting approval of the Development Master Plan (RIP) as intended in Article 11 paragraph (2), and application for the pharmaceutical industry permit as intended in Article 13 paragraph (1) are charged fees as non tax state revenue in accordance with the provisions of the regulation.
(2) In case of the application or approval as intended in paragraph (1) is rejected then the fees paid are not refundable.
Pharmaceutical Industry has the function as:
(1) Pharmaceutical industry permit applies while the pharmaceutical industry is still in production and comply with regulations.
(2) Pharmaceutical Industry which will make significant changes to the compliance requirements of CPOB, both for changes in production capacity and/or facility shall report to and obtain permit in accordance with regulations.
(1) Any change of address in the same location or change of address and change the location, change of person in charge, or the name of the industry shall made changes to permit.
(2) Changes to the company notary deed should be reported to the Director General with a copy to the Head of Agency and head of the provincial health department.
(1) Pharmaceutical Industry who make address changes and moved the location shall apply for permit changes to the Director General with a copy to the Head of Agency and head of the local provincial health department by using the sample as listed in attached Form 11.
(2) Procedures for application to change permit as intended in paragraph (1) comply with the provisions as intended in Article 13.
(1) Pharmaceutical Industry have made changes to the person in charge, the address in the same location, or industry name, shall apply for permit changes to the Director General with a copy to the Head of Agency and head of the local provincial health department by using the sample as listed in attached Form 12.
(2) The provisions on the application for the change as intended in paragraph (1) following the procedure for application for permit as intended in Article 13 paragraph (3), paragraph (5), paragraph (7), and paragraph (8).
(3) The Director General after receiving a recommendation from the head of the provincial health department issued a change of permit.
(1) Pharmaceutical Industry that produces drugs can distribute their products directly to pharmaceutical wholesalers, pharmacy stores, hospital pharmacy, community health centers, clinics, and drug stores in accordance with the provisions of the regulations.
(2) Pharmaceutical Industry that produces drug substances can distribute their products directly to wholesalers of pharmaceutical raw substances, and hospital pharmacy installation in accordance with the provisions of the regulation.
(1) Pharmaceutical Industry can make a contract to other Pharmaceutical Industry that has been implemented CPOB.
(2) Pharmaceutical Industry contract giver must has pharmaceutical industry permit and at least has 1 (one) preparation production facilities that meet the requirements of CPOB.
(3) Pharmaceutical Industry contract giver and Pharmaceutical Industry contract recipient are responsible for the safety, efficacy/usefulness, and quality of drugs.
(4) Further provisions on the making of contract drug determined by the Head of Agency.
(1) Pharmaceutical Industry may make agreement with individuals or business entities that own the intellectual property right in the field of drug and/or drug substances to make the drug and/or drug substances.
(2) The agreement as intended in paragraph (1) shall contain provisions that the drug distribution permit on the agreement held by the Pharmaceutical Industry.
(1) Pharmaceutical industry shall submit periodic industry reports on its business operations:
(2) Pharmaceutical Industry Report as intended in paragraph (1) shall be submitted to the Director General with a copy to the Head of Agency.
(3) Pharmaceutical Industry Report as intended in paragraph (1) a shall be submitted no later than January 15 and July 15.
(4) Pharmaceutical Industry as intended in paragraph (1) b shall be submitted no later than January 15.
(5) The report as intended in paragraph (1) may be reported electronically.
(6) The Director General may change the report format and contents as required.
(1) Fostering on the Pharmaceutical Industry development carried out by the Director General.
(2) Guidelines for the fostering as intended in paragraph (1) shall be determined by the Director General.
(1) Supervision of the Pharmaceutical Industry as governed in this Regulation is done by the Head of Agency.
(2) In execute supervision as intended in paragraph (1) supervisors can perform inspection and:
(1) Violation of the provisions of this Regulation may be subject to administrative sanctions in the form of:
(2) Temporary stopping of the activities as intended in paragraph (1) d can be subject for all activities or a part of activities.
(3) The administrative sanctions as intended in paragraphs (1) a up to d are given by the Head of Agency.
(4) The administrative sanctions as intended in paragraphs (1) e and f are given by the Director General on the recommendation of the Head of the Agency.
Every person in charge of the place where the inspection by inspectors has the right to refuse inspection if the relevant inspectors are not equipped with identification and inspection assignment.
If the test results indicate the presence of alleged or suspected criminal violations in the field of drugs and/or drug substance, immediately conducted an investigation by the Civil Servant Investigators are authorized in accordance with the regulation.
Further provisions on supervision will be governed by the Head of Agency.
(1) When this Regulation comes into force, principle permit already obtained remains valid as one phase to obtain the pharmaceutical industry permit based on this Regulation.
(2) Application for pharmaceutical industry permit that was applied before this Regulation comes into force will be processed based on the Decree of the Minister of Health No. 245/Menkes/SK/X/1990 concerning Provisions and Implementation Procedures on the Granting Pharmaceutical Industry Business Permit.
(3) Pharmaceutical Industrial Permit issued based on Decree of the Minister of Health No. 245/Menkes/SK/X/1990 concerning Provisions and Implementation Procedures on the Granting Pharmaceutical Industry Business Permit is remain valid.
(4) Pharmaceutical industry Permit as intended in paragraph (3) should be renewed in accordance with the requirements of this Regulation at the latest 2 (two) years from the date of promulgation.
When this Regulation comes into force, all implementing regulations of the Decree of the Minister of Health No. 245/Menkes/SK/X/1990 concerning Provisions and Implementation Procedures on the Granting Pharmaceutical Industry Business Permit still remain valid as long as not contrary to the provisions of this Regulation and/or have not been replaced by the provisions of this Regulation.
When this Regulation comes into force, Decree of the Minister of Health No. 245/Menkes/SK/X/1990 concerning Provisions and Implementation Procedures on the Granting Pharmaceutical Industry Business Permit shall be revoked and declared null and void.
This Regulation shall come into force on the date of promulgation.
For public cognizance, this Regulation shall be promulgated by placing it in the State Gazette of the Republic of Indonesia.
Stipulated in Jakarta
on December 16, 2010
MINISTER OF HEALTH,
Signed,
ENDANG RAHAYU SEDYANINGSIH