REGULATION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL
No. HK.00.05.41.1384

ON
CRITERIA AND PROCEDURES FOR REGISTRATION OF TRADITIONAL MEDICINES,
STANDARDIZED-HERBAL MEDICINES AND PHYTOPHARMACY
BY GRACE OF GOD THE ALMIGHTY

Considering:

• a. that in order to protect communities from distribution and consumption of traditional medicines, standardized herbal medicines and phyto-pharmacy failing to meet the quality, security and efficacy requirements, the medicines need to be evaluated through registration before distributing;
• b. that the evaluation of traditional medicines, standardized. herbal medicines and phyto-pharmacy covering the quality, security and efficacy must follow scientific and technological developments;
• c. that in connection with the matters in letters a and b, it is necessary to stipulate a regulation of the Head of National Agency of Food And Drug Control on Criteria and Procedures for Registration of Traditional Medicines, Standardized-Herbal Medicines and PhytoPharmacy;

In view of:

• 1. Law No. 23/1992 on Health (Statute Book of 1992 No. 10, Supplement to Statute Book No. 3495);
• 2. Law No. 8/1999 on Consumer Protection (Statute Book of 1999 No. 42, Supplement to Statute Book No. 3821);
• 3. Government Regulation No. 17/2001 on Tariffs of Non-Tax State Revenues Effective Within the National Agency of Food And Drug Control (Statute Book of 2001 No. 35, Supplement to Statute Book No. 4087);
• 4. Presidential Decree No. 103/2001 on the Status, Tasks, Functions, Authority, Organizational Structures of Non-Ministerial Government Institutions as already amended by Presidential Regulation No. 11/2005;
• 5. Presidential Decree No. 110/2001 on First-echelon Organizational Units and Tasks of Non-Ministerial Government Institutions as already amended by Presidential Regulation No. 12/2005;
• 6. Decision of the Head of National Agency of Food And Drug Control No. 02001/SK/KBPOM/2001 on the Organization and Working Arrangement of the National Agency of Food And Drug Control as already amended by Decision of the Head of National Agency of Food And Drug Control No. HK.00.05.21.4231/2004;
• 7. Decision of the Head of National Agency of Food And Drug Control No. HK.00.05.4.2411 concerning Basic Provisions on Classification and Labeling of Indonesian Natural Medicines;

DECIDES:

To stipulate:

THE DECISION OF THE HEAD OF NATIONAL AGENCY OF FOOD AND DRUG CONTROL ON CRITERIA AND PROCEDURES FOR REGISTRATION OF TRADITIONAL MEDICINES, STANDARDIZED-HERBAL MEDICINES AND PHYTOPHARMACY

GENERAL PROVISION

Article 1

Referred to in this decision as:

• 1. Traditional Medicines are substances or formula of substances in the form of herbal substances, animal substances, minerals, essence preparations (galenic) or mixture thereof, already used from generation to generation for treatment on the basis of experience.
• 2. Herbal medicines (jamu) are Indonesia's traditional medicines.
• 3. Standardized-Herbal Medicines are preparations of natural medicines having their security and efficacy already proven naturally by pre-clinical test and their raw materials already standardized.
• 4. Phyto-pharmacy is preparation of natural medicines having their security and efficacy already proven naturally by pre-clinical and clinical tests and their raw materials and products already standardized.
• 5. Galenic preparation is a result of simplifying extraction coming from plants or animals.
• 6. Domestic Traditional Medicines are traditional medicines made and packed by domestic industries, which cover unlicensed traditional medicines, licensed traditional medicines and contract traditional medicines.
• 7. Licensed Traditional Medicines are traditional medicines made in Indonesia on the basis of a license.
• 8. Contract Traditional Medicines, contract standardized herbal medicines, and contract phyto-pharmacy are products whose production is entrusted to other traditional medicine industry or pharmaceutical industry on the basis of a contract.
• 9. Imported Traditional Medicines are traditional medicines made by overseas industry, which are imported and distributed in Indonesia's territory.
• 10. Distribution License is approval of registration of traditional medicines, standardized herbal medicines, and phyto-pharmacy issued by the Head of the Board so that the medicines can be distributed in Indonesia's territory.
• 11. Contract Provider is industry operating in the traditional medicine sector, which entrusts the work of production of traditional medicines, standardized herbal medicines and phyto-pharmacy on the basis of a contract.
• 12. Contract Recipient is industry operating in the traditional medicine sector, which receives the work of production of traditional medicines, standardized herbal medicines and phyto-pharmacy on the basis of a contract.
• 13. Diskette is a specifically formatted diskette for the registration of traditional medicines, standardized herbal medicines and phyto-pharmacy.
• 14. Form is registration form of traditional medicines, standardized herbal medicines and phyto-pharmacy.
• 15. Variation is change in whatever aspect in products of traditional medicines, standardized herbal medicines and phyto-pharmacy, including but not limited to change in formulation, method, industry, production place, specification of raw material and product, package, container and labeling.
• 16. Composition is a qualitative and quantitative composition of efficacious substances in traditional medicines, standardized herbal medicines and phyto-pharmacy.
• 17. Formula is a qualitative and quantitative composition of efficacious substances and additives.
• 18. Labeling is complete information about efficacy, security and method of use as well as other information deemed necessary to mention in etiquette and/ or brochures attached to traditional medicines, standardized herbal medicines and phyto-pharmacy and wrapper.
• 19. Container is a pack directly contact with content.
• 20. Wrapper is a pack not directly contact with content.
• 21. Bets is a number of traditional medicines, standardized herbal medicines and phyto-pharmacy made in a production circle, which have uniform characteristic and quality.
• 22. Head of Board is the Head of National Agency of Food And Drug Control of the Republic of Indonesia.
• 23. Deputy is Deputy for Supervision over Traditional Medicines, Cosmetics and Complementary Products of the National Agency of Food And Drug Control.

CHAPTER II
REQUIREMENTS AND CRITERIA

Part One
Requirements

Article 2

(1) Traditional medicines, standardized herbal medicines and phyto-pharmacy made and/or distributed in Indonesia's territory are obliged to secure distribution license from the Head of the Board.

(2) Registration must be executed for obtaining the distribution license as meant in paragraph (1).

Article 3

The provision in Article 2 is in exception for:

• a. traditional medicines, standardized herbal medicines and phyto-pharmacy used for research;
• b. imported traditional medicines used for direct consumption in a limited quantity;
• c. imported traditional medicines already registered and distributed in countries of origin for the need of exhibition in a limited quantity;
• d. traditional medicines without labeling, which are made by prescribed and individually mobile herbal medicine business;
• e. raw materials in the form of simplistic and galenic preparations.

Part Two
Criteria

Article 4

In order to obtain the distribution license as meant in Article 2, traditional medicines, standardized herbal medicines and phyto-pharmacy must meet the following criteria:

• a. using efficacious substances and additives fulfilling the quality, security and efficacy requirements;
• b. produced in accordance with provisions on Guidance for Proper Production Method of Medicines or Proper Medicine Production Method in force;
• c. labeling containing complete and objective information that can guarantee the right, rational and safe use of traditional medicines, standardized herbal medicines and phyto-pharmacy in accordance with results of evaluation in the framework of registration.

CHAPTER III
REGISTRANT

Part One
Registrar of Domestic Traditional Medicines, Standardized Herbal Medicines and Phyto-Pharmacy

Article 5

(1) Registrants of domestic traditional medicines, standardized herbal medicines and phyto-pharmacy consist of:

• a. registrants of unlicensed traditional medicines, registrants of standardized herbal medicines, registrants of phyto-pharmacy;
• b. registrants of licensed traditional medicines;
• c. registrants of contract traditional medicines, contract standardized herbal-medicines and contract phyto-pharmacy.

(2) The registrants of domestic traditional medicines, standardized herbal medicines and phyto-pharmacy as meant in paragraph (1) letter a are traditional medicine industries (IOT) or traditional medicine small-scale industries (IKOT) or pharmaceutical industries.

(3) The registrants of the licensed traditional medicines as meant in paragraph (1) letter b are licensees being traditional medicine industries (IOT) or pharmaceutical industries.

(4) The registrants of contract traditional medicines, contract standardized herbal-medicines and contract phyto-pharmacy as meant in paragraph (1) letter c are contract providers being traditional medicine industries (IOT) or traditional medicine small-scale industries (IKOT) or pharmaceutical industries.

Article 6

(1) Industries operating in the traditional medicine sector and pharmaceutical industry as meant in Article 5 paragraphs (2) and (3) are obliged to apply Proper Traditional-Medicine Production Method (CPOTB) or Proper Medicine Production Method (CPOB) to the production process.

(2) Further provisions on application of the Proper Traditional-Medicine Production Method to Traditional Medicine Small-scale Industries (IKOT) as meant in Article 5 paragraph (2) are regulated by the Head of the Board.

Part Two
Registrant of Imported Traditional Medicines

Article 7

(1) Registrants of imported traditional medicines are industries in the traditional medicine sector or pharmaceutical industries or business entities in the traditional-medicine marketing sector, which secure letter of direct appointment from industries in the traditional medicine sector or owners of trade names in countries of origin.

(2) The industries in the traditional medicine sector in countries of origin as meant in paragraph (1) are obliged to meet the requirements for Proper Production Method (GMP) proven by certificate in accordance the latest inspection data, maximally two years, issued by the authorized official.

Part Three
Registrant of Traditional Medicines, Standardized Herbal Medicines
and Phyto-Pharmacy Protected by Patent

Article 8

(1) Registrants of traditional medicines, standardized herbal-medicines and phyto-pharmacy protected by patent in Indonesia are industries in the traditional medicine sector or pharmaceutical industries as owners of patent rights or authorized by owners of patent rights or securing the transfer of patent from owners of patent rights in accordance with the provisions in force.

(2) The patent rights as meant in paragraph (1) must be proven by certificate of patent.

(3) The transfer of patent as meant in paragraph (1) must be proven by transfer of patent in accordance with the provisions in force.

Part Four
Responsibility of Registrant

Article 9

Registrants are responsible for:

• a. the completeness of the given up documents;
• b. the truth of all information mentioned in registration document;
• c. the truth and legitimacy of documents enclosed to the completeness of registration;
• d. change in data and information about products, which are in the course of registration.

CHAPTERI V
CATEGORY OF REGISTRATION

Article 10

(1) Registration, of traditional medicines, standardized herbal-medicines and phyto-pharrnacy is categorized to become new registration and variation registration.

(2) The new registration as meant in paragraph (1) consists of:

• a. Category 1: registration of traditional medicines only containing simplistic substances coming from Indonesia (indigenous) in the form of simple preparations (cuts, powder, ointment, compress, taffy, external medicine liquid);
• b. Category 2: registration of traditional medicines only containing simplistic substances coming from Indonesia (indigenous) in the form of modern preparations (pill, tablet, capsule, cream, gel, ointment, suppository anal, internal medicine liquid);
• c. Category 3: registration of the traditional medicines belonging to categories 1 and 2 with claim of new indication, model of new preparation, posology and new dosage;
• d. Category 4: registration of standardized herbal medicines;
• e. Category 5: registration of phyto-pharmacy;
• f. Category 6: registration of categories 4 and 5 with claim of new indication, model of new preparation, posology and new dosage;
• g. Category 7: registration of traditional medicines containing simplistic substances not coming from Indonesia (non indigenous) and/or simplistic substances whose safety profile remains unknown precisely;
• h. Category 8: registration of traditional medicines belonging to category 7 with claim of new indication, model of new preparation, posology and new dosage.

(3) Registration of variation as meant in paragraph (1) consists of:

• a. Category 9: registration of traditional medicines, standardized herbal-medicines and phyto-pharmacy already securing distribution license with:
• 9.1. Change in name of product without change in composition;
• 9.2. Change or addition to size of package;
• 9.3. Change in claim in labeling not changing benefit;
• 9.4. Change in design of package;
• 9.5. Change in name of factory or name of licensor, without change in ownership status;
• 9.6. Change in name of importer, without change in ownership status.
• b. Category 10: registration of traditional medicines, standardized herbal-medicines and phyto-pharmacy already securing distribution license with:
• 10.1. Change in specification and/ or analysis method of raw materials;
• 10.2. Change in specification and/ or analysis method of product;
• 10.3. Change in stability;
• 10.4. Change in production technology;
• 10.5. Change in production place;
• 10.6. Change or addition to kind of package.
• c. Category 11: registration of traditional medicines, standardized herbal-medicines and phyto-pharmacy already securing distribution license with change in formula or composition, including additives not changing efficacy.

CHAPTER V
PROCEDURES FOR SECURING DISTRIBUTION LICENSE

Part One
Registration

Article 11

(1) Registration is submitted by registrants to the Head of the Board.

(2) Registration of traditional medicines, standardized herbal-medicines and phyto-pharmacy is done in 2 (two) phases, namely pre-evaluation and evaluation.

(3) The pre-evaluation as meant in paragraph (2) constitutes a phase of examination of completeness, legitimacy of documents and stipulation of the categories as meant in Article 10.

(4) The evaluation as meant in paragraph (2) constitutes a process of evaluation of documents and supporting data.

Article 12

(1) Results of pre-evaluation are notified in writing to registrants and binding.

(2) The results of pre-evaluation as meant in paragraph (1) are notified in not later than 10 (ten) working days in the case of variation registration and 10 (twenty) working days in the case of new registration, as from the date of receipt of registration documents.

Article 13

The Head of the Board keep in secrecy data and everything related to evaluation in the framework of registration.

Article 14

Registration is subjected to cost in accordance with the provisions of legislation in force.

Article 15

(1) Submission of registration is realized by giving up registration documents consisting of registration form or registration diskette already completed, accompanied by administrative documents and supporting documents.

(2) The administrative documents as meant in paragraph (1) are as contained in Attachment 1.

(3) The registration for or diskette is provided by the National Agency of Food And Drug Control.

Article 16

(1) The supporting documents of the traditional medicines, standardized herbal-medicines and phyto-pharmacy as meant in Article 15 paragraph (1) consist of:

• a. quality and technology document in accordance with Attachment 2;
• b. documents supporting claims about indication in accordance kind and level of verification.

(2) Guidance for indication claim as meant in paragraph (1) letter b is stipulated separately.

Article 17

(1) The registration documents as meant in Article 15 paragraph (1) must be accompanied ;

• a. planned package, covering etiquette, doz, wrapper, strip, blister, catch over and other package in accordance with the provisions on wrapper and labeling in force, which constitutes design for package of traditional medicines, standardized herbal-medicines and phyto-pharmacy, which will be distributed and must be accompanied by planned color;
• b. brochure mentioning information about traditional medicines, standardized herbal-medicines and phyto-pharmacy.

(2) The minimal information, which must be mentioned in the designed package and brochure as meant in paragraph (1) is in accordance with Attachment 3.

Article 18

Registration of contract traditional-medicines, contract standardized herbal-medicines and contract phyto-pharmacy, licensed traditional-medicines and imported traditional-medicines also must meet the provisions as contained in Attachment 4, besides the provisions of legislation regarding registration of traditional medicines, standardized herbal-medicines and phyto-pharmacy.

Article 19

(1) In the case of the new registration as meant in Article 10 paragraph (2), the given up documents in accordance with Attachment 5 consist of:

• a. form TA containing information about administrative documents;
• b. form TB containing documents covering formula and production method;
• c. form TC containing documents covering analysis method of quality of raw materials and products;
• d. form TD containing documents covering indication claim, dosage, consumption method and bets.

(2) In the case of the variation registration as meant in Article 10 paragraph (3), given up documents consist of variation registration forms in accordance with Attachment 6 and completeness of variation registration for respective categories in accordance with Attachment 7.

Part Two
Completion of Form

Article 20

(1) Completion of registration form, administrative documents and supporting documents follows the following provisions:

• a. The registration form must be completed by the Indonesian language and/or English language;
• b. The registration form can use the Indonesian language and/or English language;
• c. Labeling of domestic traditional medicines, standardized herbal-medicines and phyto-pharmacy must use the Indonesian language;
• d. Labeling of imported traditional medicines must use the Indonesian language, besides the original language.

(2) Directives for completing the registration form are in accordance with Attachment 8.

Part Three
Evaluation

Article 21

(1) Documents of registration of traditional medicines, standardized herbal-medicines and phyto-pharmacy already fulfilling the provisions as meant in Articles 14 and 15 are evaluated in accordance with the provision as meant in Article 4.

(2) Evaluation of new registration is realized through: b

• a. Lane 1:
  1.1. for products of categories 1 and 2 using general name with single composition or simple composition (maximally five kinds of substances);
• 1.2. for products of category 9 whose variation does not influence the quality and security.
• b. Lane 2:
  2.1. for products of categories 1 and 2 using trade name with single or complex composition;
• 2.2. for products of category 10 whose variation influences the quality.
• c. Lane 3:
  3.1. for products of category 3;
• 3.2. for products of category 11 whose variation influences the quality.
• d. Lane 4: for products of categories 6 and 8;
• e. Lane 5: for products of categories 4, 5 and 7

Article 22

(1) In order to undertake the evaluation as meant in Article 21, the Traditional Medicine Evaluation Committee (PPOT) and the National Commission for Traditional Medicine Evaluation (KOMNAS POT) are established.

(2) The Deputy stipulates the establishment, tasks and functions of PPOT as meant in paragraph (1).

(3) The Head of the Board stipulates the establishment, tasks and functions of KOMNAS POT as meant in paragraph (1).

Article 23

Results of evaluation of quality, security and efficacy can be in the form of fulfilling the requirements, not yet fulfilling the requirements or not fulfilling the requirements.

Part Four
Making Decision

Article 24

In the case of the requirements as meant in Article 23 being fulfilled, the Head of the Board makes a decision on approval of registration by using the format according to Attachment 9.

Article 25

(1) In the case of the requirements as meant in Article 23 being not yet fulfilled, the required additional data will be informed in writing by using format in accordance with Attachment 10.

(2) Registrants already receiving the request for additional data as meant in paragraph (1) are obliged:

• a. to give the additional data in not latter than 3 (three) months as from the date of notification;
• b. in the case of the 3 (three)-month period as meant in letter a already elapsing, the registration documents are returned by letter in accordance with Attachment 11;
• c. the returned documents as meant in letter b can be submitted again as new registration and are completed by the additional data as meant in paragraph (1).

Article 26

In the case of the requirements as meant in Article 23 being not fulfilled, the Head of the Board makes decision by using format in accordance with Attachment 12.

Article 27

The decision on results of evaluation is given as from the date of receipt of the complete registration documents, accompanied by the payment form as meant in Article 14 in not later than:

• a. 7 (seven) working days, in the case of registration of lane 1 (one);
• b. 15 (fifteen) working days, in the case of registration of lane 2 (two);
• c. 30 (thirty) working days, in the case of registration of lane 3 (three);
• d. 60 (sixty) working days, in the case of registration of lane 4 (four);
• e. 90 (seven) working days, in the case of registration of lane 5 (five).

Part Five
Hearing

Article 28

(1) In the case of decision not yet fulfilling the requirement as meant in Article 25 or not fulfilling the requirement as meant in Article 26, registrants can raise objection in writing with the mechanism of hearing to the Head of the Board.

(2) The objection as meant in paragraph (1) is submitted in not later than 3 (thirty) working days as from the date of the decision.

Article 29

(1) Based on result of the hearing as meant in Article 28, results of the evaluation can be reviewed.

(2) In the case of the review as meant in paragraph (1), registrants must complete by new data and/or data once submitted, along with justification.

(3) Result of the review can be in the form of approval or rejection of the submitted objection.

Part Seven
Approval of Registration

Article 30

Approval of registration of traditional medicines, standardized herbal-medicines and phyto-pharmacy applies for 5 (five) years as long as the provisions in force are fulfilled and can be extended through re-registration.

CHAPTER VI
REALIZATION OF DISTRIBUTION LICENSE

Article 31

(1) Registrants are obliged to make traditional medicines, standardized herbal-medicines and phyto-pharmacy or import traditional medicines already securing distribution license in not later than one year after the date of issuance of the distribution license.

(2) Registrants must give up package ready for distribution to the Head of the Board in not later than one month before the traditional medicines, standardized herbal-medicines and phyto-pharmacy are made or traditional medicines are imported.

(3) Registrants are obliged to report information about activity of production or import periodically, every six months to the Head of the Board.

CHAPTER VII
REVALUATION

Article 32

(1) The Head of the Board can revaluate traditional medicines, standardized herbal-medicines and phyto-pharmacy already securing distribution license.

(2) The revaluation as meant in paragraph (1) is done in the case of new data and/or information about the quality, security and efficacy influencing the public health.

CHAPTER VIII
NULLIFICATION

Article 33

(1) The Head of the Board can nullify distribution license of traditional medicines, standardized herbal-medicines and phyto-pharmacy in the case:

• a. on the basis of study or monitoring after the distribution, the products failing to meet the criteria as meant in Article 4;
• b. labeling being not in accordance with the approved;
• c. promotion deviating from the provisions in force; or
• d. the obligation as meant in Article 31 being not executed; or
• e. traditional medicines, standardized herbal-medi¬cines and phyto-pharmacy being not produced or imported for 2 (two) years consecutively;
• f. industrial license in the traditional medicine sec¬tor, license of pharmaceutical industry or busi¬ness entity being revoked; or
• g. owner of distribution license committing violation in the production of traditional medicines, stan¬dardized herbal-medicines and phyto-pharmacy or in the import of traditional medicines.

(2) The Head of the Board nullifies the distribution li¬cense as meant in paragraph (10 by using the for¬mat in accordance with Attachment 13.

CHAPTER IX
PROHIBITION

Article 34

(1) Traditional medicines, standardized herbal-medicines and phyto-pharmacy are prohibited from containing:

• a. chemical substances resulting from isolation or synthetic having medicine efficacy;
• b. narcotics or psychotropics;
• c. the banned substances as meant in Attachment 14;
• d. protected animals or plants in accordance with the provisions of legislation in force.

(2) Traditional medicines are prohibited from having the following forms of preparation:

• a. Intra-vaginal;
• b. Eye drop;
• c. Parenteral;
• d. Suppository, unless otherwise used for hemor¬rhoids.

(3) Traditional medicines, standardized herbal-medicines and phyto-pharmacy in the form of internal medi¬cine liquid may not contain ethyl alcohol with the con¬tent exceeding 1% (one percent), unless otherwise in the form of tincture preparation is used by dilution.

CHAPTER X
SANCTION

Article 35

(1) Violation of the provisions in this regulation is liable to administrative sanctions in the form of:

• a. written warning;
• b. withdrawal of traditional medicines, standardized herbal-medicines and phyto-pharmacy from the distribution, including withdrawal of advertisement;
• c. suspension of production, distribution, storage, transport and delivery of traditional medicines, standardized herbal-medicines and phyto-phar¬macy and imported traditional medicines;
• d. freezing and/or revocation of distribution license of traditional medicines, standardized herbal¬ medicines and phyto-pharmacy.

(2) Besides the administrative sanctions as meant in paragraph (1), criminal sanction can be imposed in accordance with the provisions of legislation in force.

CHAPTER XI
TRANSITIONAL PROVISION

Article 36

(1) All regulations already issued before the stipulation of this regulation remain effective as long as they do not contravene and have not been replaced by this regulation.

(2) Traditional medicines, standardized herbal-medicines and phyto-pharmacy already having distribution li¬cense before the stipulation of this regulation must adjust in not later than 2 (two) years as from the date of stipulation of this regulation.

CHAPTER XII
CONCLUSION

Article 37

(1) Technical matters not yet regulated sufficiently in this regulation will be regulated further.

(2) The regulation comes into force as from the date of stipulation.

Stipulated in Jakarta
On March 2, 2005
THE HEAD OF NATIONAL AGENCY OF FOOD AND DRUG CONTROL,
Sgd
H. SAMPURNO