REGULATION OF THE MINISTER OF HEALTH
NO. 949/MENKES/PER/VI/2000

CONCERNING
REGISTRATION OF FINISHED DRUGS

THE MINISTER OF HEALTH,

Considering :

• a. that with a view to protecting society from the distribution of finished drugs which fail to meet requirements for effectiveness, safety, quality and benefit, it is necessary to conduct evaluation through registration of finished drugs before their distribution;
• b. that several regulations which stipulate provisions on finished drugs are no longer compatible with the present policy so that it is necessary to review and restipulate provisions on registration of finished drugs in a ministerial regulation.

In view of :

• 1. The Potent Drug Law (Statute Book of 1949 No.419);
• 2. Law No. 23/1992 on health affairs (Statute Book of 1992 No. 100, Supplement to Statute Book No. 3495);
• 3. Law No. 5/1997 on psychotropic (Statute Book of 1997 No. 10, Supplement to Statute Book No. 3671);
• 4. Law No. 22/1997 on narcotics (Statute Book of 1997 No. 67, Supplement to Statute Book No. 3698);
• 5. Law No. 8/1999 on health affairs (Statute book of 1999 No. 42, Supplement to Statute Book No. 3821);
• 6. Government Regulation No. 72/1998 on the safeguarding of pharmaceutical preparations and health equipment (Statute Book of 1998 No. 138, Supplement to Statute Book No. 3778);
• 7. Presidential Decree No. 136/1999 on the status, duties, functions, organisational structures and working procedures of ministries;
• 8. The Decree of the Minister of Health No. 130/MENKES/SK/I/2000 on the organisation and working procedure of the Ministry and Health.

DECIDES:

To stipulate:

THE REGULATION OF THE MINISTER OF HEALTH CONCERNING REGISTRATION OF FINISHED DRUGS

CHAPTER I
GENERAL PROVISIONS

Article 1

Hereinafter referred to as:

• 1. The distribution licence shall be the approval of registration of finished drugs as a requirement for their distribution in the territory of Indonesia.
• 2. Finished drugs shall be preparations or mixtures of materials including biological and contraception products, which are ready for use to affect or probe physiological systems or pathological conditions within the framework of diagnosis, prevention, cure, rehabilitation and health promotion.
• 3. Biological products shall be vaccines, immunosera, antigens, hormones, enzimes, products of blood and other fermentation products (including monoclonal antibodies and products originating in DNA recombinant technology), which are used to affect or probe physiological systems or pathological conditions within the framework of prevention, cure, rehabilitation and health promotion.
• 4. New finished drugs shall be finished drugs with new effective substances or compositions or forms of preparations/methods of application or indications or posology which have never been approved in Indonesia.
• 5. Finished drugs of the same type shall be finished drugs containing the same effective substances as those in registered finished drugs.
• 6. Contract finished drugs shall be finished drugs whose manufacturing is delegated to the pharmaceutical industries.
• 7. Contract grantors shall be pharmaceutical industries or other bodies delegating/authorizing the manufacture of drugs on a contract basis.
• 8. Contract recipients shall be pharmaceutical industries receiving the job of drugs manufacturing on a contract basis.
• 9. Import finished drugs shall be finished drugs which are products of foreign pharmaceutical industries.
• 10. Indications shall be complete information on finished drugs, effectiveness, safety, methods of use and other information deemed necessary as printed on labels, brochures and boxes of finished drugs.
• 11. Fake drugs shall be drugs produced by unauthorized parties based on the laws in force or products with indications imitating the identities of other drugs already licensed for distribution.
• 12. Psychotropics shall be substances or drugs, natural as well as synthetic, which are non narcotics, with psychoactive effects through their selective influence on the central nervous system, causing typical changes in mental activity and behaviour.
• 13. Distribution shall be any activity or a series of activities of distribution or delivery of finished drugs within the framework of trade, non trade or transfer activities.
• 14. Products protected by patents shall be products securing patent protection on the basis of the Patents Law effective in Indonesia.
• 15. The Director General shall be the Director General of Food and Drug Control.

Article 2

Finished drugs which are distributed in the territory of Indonesia shall be subjected to prior registration as a requirement for obtaining distribution licences.

CHAPTER II
CRITERIA

Article 3

Finished drugs which are entitled to distribution licences shall fulfil the following criteria:

• a. having convincing effectiveness and adequate safety, as evidenced by animal experiments and clinical tests or other proofs according to the status of progress of relevant sciences;
• b. having quality which meet relevant requirements, as evaluated according to the process of production based on CPOB (appropriate drug manufacturing method), specifications and test methods, involving all materials used and finished products with legitimate evidence;
• c. having indications which contain complete and objective information as a guarantee for correct, rational and safe use/application of drugs;
• d. being in line with concrete demand of the public;
• e. Other criteria are:
• - especially with regard to psychotropic, they must have an edge in benefit and safety over standard drugs and drugs already approved for distribution in Indonesia in the indications sent;
• - especially with regard to contraceptives for the national program and other program drugs to be further determined, they must be subjected to clinical tests in Indonesia.

Article 4

(1) Finished drugs for clinical tests shall be proved that the said drugs are effective and safe for human application/consumption.

(2) Provisions on the implementation of clinical tests shall be separately stipulated.

CHAPTER III
REQUIREMENTS FOR REGISTRATION

Part One
Registration of Domestic Finished Drugs

Article 5

(1) Registration of domestically made finished drugs shall only be done by pharmaceutical industries possessing at least principle licences.

(2) The pharmaceutical industries as meant in paragraph (1) shall meet the requirements for CPOB.

(3) The fulfilment of CPOB requirements as meant in paragraph (2) shall be declared by authorised pharmaceutical control officers after inspecting the pharmaceutical industries concerned.

Part Two
Registration of Contract Finished Drugs

Article 6

(1) Registration of contract finished drugs shall only be done by contract grantors by attaching contract documents.

(2) The contract grantors as meant in paragraph (1) shall be pharmaceutical industries or other bodies.

(3) The pharmaceutical industries as contract grantors as meant in paragraph (2) shall possess pharmaceutical industrial licences and each at least another facility of production of preparations already meeting CPOB requirements.

(4) Contract grantor pharmaceutical industries shall be responsible for the quality of finished drugs produced on a contract basis.

(5) Contract recipients shall possess pharmaceutical industrial licences and production facilities already meeting CPOB requirements for preparations under the contract arrangement.

(6) Provisions on requirements for other bodies as contract grantors as meant in paragraph (2) shall be separately stipulated.

Part Three
Registration of Import Finished Drugs

Article 7

(1) Registration of import finished drugs shall give priority to public health program drugs and their registration shall be done by domestic pharmaceutical industries or pharmaceutical wholesalers obtaining written approval from pharmaceutical industries or overseas owners of products.

(2) The domestic pharmaceutical industries as meant in paragraph (1) shall show evidence of the ratio of import and export activities conducted.

(3) The overseas pharmaceutical industries as meant in paragraph (1) shall fulfil CPOB requirements.

(4) The fulfilment of CPOB requirements by the pharmaceutical industries as meant in paragraph (3) shall be evidenced by appropriate documents or if necessary be subjected to inspection by authorised officers.

(5) The documents as meant in paragraph (4) shall be complete with inspection data of at most the past two years issued by local authorised officials.

(6) Provisions on the procedure for spot inspection as meant in paragraph (4) shall be separately stipulated.

Part Four
Registration of Finished Drugs for Exports

Article 8

(1) Registration of finished drugs especially for exports shall only be done by pharmaceutical industries.

(2) The finished drugs for exports as meant in paragraph (1) shall fulfil the criteria as stipulated in Article 3, unless they are accompanied by written approval from destination countries.

Part Five
Registration of Finished Drugs Protected by Patents

Article 9

(1) Registration of finished drugs with effective substances protected by patents in Indonesia shall only be done by domestic pharmaceutical industries holding patent rights, or other pharmaceutical industries or pharmaceutical wholesalers appointed by holders of patent rights.

(2) The patent rights as meant in paragraph (1) shall be evidenced by patent certificates.

(3) Registration of finished drugs with effective substances protected by patents in Indonesia other than that as meant in paragraph (1) shall only be done after fulfilling patent provisions effective in Indonesia.

CHAPTER IV
PROCEDURE FOR OBTAINING DISTRIBUTION LICENCES

Part One
Registration

Article 10

(1) Registration of finished drugs shall be filed to the Director General.

(2) Registration of finished drugs shall be done in two phases viz. pre-registration and delivery of registration documents.

(3) The procedure for registration as meant in paragraph (2) shall be stipulated by the Director General.

(4) The delivery of registration documents as meant in paragraph (2) shall be done by using registration forms complete with supporting documents stipulated by the Director General.

(5) The registration documents as meant in paragraph (4) shall be only limitedly used for the purpose of evaluation by authorised personnel pursuant to the provisions in force.

Part Two
Fees

Article 11

(1) Registration of finished drugs shall be subjected to fees for evaluation.

(2) Provisions on the evaluation fees as meant in paragraph (1) shall be separately stipulated.

Part Three
Evaluation

Article 12

(1) Registration documents of finished drugs already fulfilling the provisions as meant in Article 10 shall be evaluated according to the criteria as meant in Article 3.

(2) The evaluation of registration of finished drugs shall distinguish between new finished drugs and finished drugs of the same type.

(3) The evaluation shall be implemented through channel I (one), channel II (two) or channel III (three).

Article 13

(1) The finished drugs evaluated through channel one shall be:

• a. Generic essential drugs for public health programs;
• b. Drugs indicated for therapy of serious diseases and human life threatening diseases.

(2) The finished drugs as meant in paragraph (1) shall be stipulated by the Director General.

Article 14

The finished drugs evaluated through channel two shall be:

• a. New finished drugs already approved in the group of countries applying the harmonised evaluation system and one country applying the evaluation system which has been familiar and supported by independent evaluation reports;
• b. New finished drugs already approved in three countries applying the evaluation system which has been familiar and supported by independent evaluation reports.

Article 15

Finished drugs which are excluded from Article 13 and Article 14 shall be evaluated through channel three.

Article 16

(1) In order to conduct evaluation, the following units shall be set up:

• a. The National Committee for Evaluation of Finished Drugs (KOMNAS POJ);
• b. The Committee for Evaluation of Safety-Effectiveness;
• c. The Committee for Evaluation of Quality, Technology, Indications and Rationality of Finished Drugs.

(2) The establishment, duties and functions of KOMNAS POJ and the evaluation committees as meant in paragraph (1) shall be separately stipulated.

Article 17

(1) In the case of necessity of additional data for evaluation, the Director General shall make written notifications by using the REG-I model form.

(2) Registerers shall deliver the additional data as meant in paragraph (1) not later than 120 (a hundred and twenty) days as from the date of notification.

(3) In the case of registerers failing to fulfil the provision as meant in paragraph (2), the Director General shall issue letters of rejection of registration by using the REG-II model form.

(4) Registration which is rejected as meant in paragraph (3) can again be filed as new registration with documents as meant in Article 10 paragraph (4) and additional data as meant in paragraph (2).

Article 18

(1) Results of evaluation of effectiveness and safety from KOMNAS POJ shall be conveyed to registerers in writing by using the REG-III model form.

(2) In the case of the presence of objections against the results of the evaluation as meant in paragraph (1), registerers can propose hearings.

Part Four
Decision making

Article 19

(1) Based on recommendations submitted by KOMNAS POJ, the Committee for Evaluation of Safety-Effectiveness and the Committee for Evaluation of Quality, Technology, Indications and Rationality of Finished Drugs, the Director General shall make decisions in the form of distribution licences by using the REG-IV model form or rejections by using the REG-V model form.

(2) The decisions as meant in paragraph (1) shall be granted as from the date of receipt of complete registry documents not later than:

• a. Channel one, 100 working days;
• b. Channel two, 150 working days;
• c. Channel three for new finished drugs, 300 working days; for drugs of the same type 150 working days; for finished drugs of the same type with electronic facilities and finished drugs specially for exports, 80 working days.

Part Five
Review

Article 20

(1) In the case of registration being rejected, registerers can raise objections through a mechanism of review to the Director General.

(2) The submission of review shall be accompanied by documents containing supporting data.

(3) The review as meant in paragraph (2) shall be evaluated by the Director General along with KOMNAS POJ, the Committee for Evaluation of Safety-Effectiveness and the Committee for Evaluation of Quality, Technology, Indications and Rationality of Finished Drugs.

(4) Results of the evaluation as meant in paragraph (3) can be in the form of approval of distribution licences or rejection.

(5) Applications for review can only be submitted twice and not later than 6 (six) months as from the date of rejection at the maximum.

Part Six
Granting of Distribution Licences

Article 21

(1) Distribution licences shall only be granted to registerers fulfilling the following requirements:

• a. administrative requirement, in the form of registration documents accompanied by supporting documents;
• b. technical requirement, in the form of evaluation and test from the aspects of effectiveness, safety, quality, benefit and indications.

(2) Distribution licences of finished drugs shall be effective as long as the provisions in force are fulfilled.

CHAPTER V
THE IMPLEMENTATION OF DISTRIBUTION LICENCES

Article 22

(1) Registerers already securing distribution licences shall be obliged to produce or import and distribute the drugs not later than one year after the date of issuance of approval.

(2) The implementation of the provision as meant in paragraph (1) shall be reported to the Director General by using the REG-VI model form.

(3) Holders of distribution licences shall pay annual fees of distribution licences stipulated separately.

CHAPTER VI
REVALUATION

Article 23

(1) The Director General can revaluate finished drugs already securing distribution licences.

(2) The revaluation of finished drugs already distributed shall be subjected to:

• a. drugs with side effect risks being higher than effectiveness revealed after the drugs are marketed;
• b. drugs with effectiveness being not better than placebos;
• c. drugs failing to meet requirements for the availability of biological/bioequivalent resources.

(3) Pharmaceutical industries/registerers shall withdraw the revaluated drugs as meant in paragraph (2) from distribution.

(4) Revaluation shall also be done for the improvement of compositions and formulas of finished drugs.

CHAPTER VII
ANNULMENT OF DISTRIBUTION LICENCES

Article 24

The Director General can nullify distribution licences by using the REG-VII model form, in the case of the occurrence of any of the following matters:

• a. based on evaluation or monitoring of the use after registration, failing to meet criteria as meant in Article 3.
• b. indications and promotion deviating from approval of distribution licences.
• c. failing to fulfil the obligations as meant in Article 22.
• d. the relevant drugs are not produced, imported or distributed for 12 (twelve) months consecutively.
• e. licences of pharmaceutical industries, pharmaceutical wholesalers registering, producing or distributing drugs are revoked.
• f. holders of distribution licences commit violations in the fields of production and distribution of finished drug.

Article 25

Registerers producing fake drugs shall be subjected sanctions according to the laws in force.

CHAPTER VIII
SANCTIONS

Article 26

Whoever distribute finished drugs not according to the provisions on distribution licences as stipulated in this Regulation shall be subjected to criminal sanctions in accordance with the provisions in Article 80 paragraph (4) and Article 81 paragraph (2) of Law No. 23/1992 on health affairs.

CHAPTER IX
TRANSITIONAL PROVISION

Article 27

All provisions on the procedure for registration of finished drugs already issued before the stipulation of this regulation shall remain effective as long as they do not contravene the provisions in this regulation.

CHAPTER X
CONCLUSION

Article 28

With the stipulation of this regulation, Regulations of the Minister of Health No. 917/Menkes/Per/X/1993 on the obligation to register finished drugs, No. 920/Menkes/Per/X/1993 concerning the provisions on registration of imported finished drugs and No. 921/Menkes/Per/X/1993 on the production of drugs on a contract basis shall be declared null and void.

Article 29

This regulation shall come into force as from the date of stipulation.

For public cognizance, this regulation shall be published by placing it in the State Gazette of the Republic of Indonesia.

Stipulated in Jakarta
On June 26, 2000

THE MINISTER OF HEALTH
sgd
Dr. ACHMAD SUJUDI