REGULATION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL OF THE REPUBLIC OF INDONESIA
No. HK.00.05.41.1381

ON
PROCEDURE OF FOOD SUPPLEMENT REGISTRATION

BY GRACE OF GOD THE ALMIGHTY
THE HEAD OF NATIONAL AGENCY OF FOOD AND DRUG CONTROL OF THE REPUBLIC OF INDONESIA,

Considering:

• a. that in order to protect communities from circulation and consumption of food supplement failing to meet the quality, security and efficacy requirements, the food supplements need to be evaluated through registration before circulation;
• b. that in connection with the matters in letter a, it is necessary to stipulate a regulation of the Head of National Agency of Food And Drug Control on Procedure of Food Supplement Registration.

In view of:

• 1. Law No. 23/1992 on Health (Statute Book of 1992 No. 100, Supplement to Statute Book No. 3495);
• 2. Law No. 7/1996 on Food (Statute Book No. 99/1996, Supplement to Statute Book No. 3656);
• 3. Law No. 8/1999 on Consumer Protection (Statute Book of 1999 No. 42, Supplement to Statute Book No. 3821);
• 4. Government Regulation No. 17/2001 on Non-Tax State’s Revenue Rate applicable in the National Agency of Drug and Food Control (Statute Book of 2001 No. 35, Supplement to Statute Book No. 4087);
• 5. Presidential Decree No. 103/2001 on Status, Duties, Functions, Authorities, Organizational Structure and Activity of Non Departmental Government Institution as amended by Presidential Decree No. 11/2005;
• 6. Presidential Decree No. 110/2001 on Organisation Unit and Duties of Echelon I in Non Departmental Government Institutions as amended by Presidential Decree No. 12/2005;
• 7. Decision of the Head of National Agency of Drug and Food Control No. 02001/SK/KBPOM/2001 on Organisation and Work System of the National Agency of Drug and Food Control;
• 8. Decision of the Head of National Agency of Drug and Food Control No. HK.00.05.23.3644/2004 On Basic Provisions Of Food Supplement Control.

DECIDES:

To stipulate:

REGULATION OF THE HEAD OF NATIONAL AGENCY OF FOOD AND DRUG CONTROL ON PROCEDURE OF FOOD SUPPLEMENT REGISTRATION

CHAPTER I
GENERAL PROVISION

Article 1

Referred to in this decision as:

• 1. Domestically manufactured food supplement shall be a food supplement which is domestically manufactured and packaged by industry in Indonesia including unlicensed food supplement, licensed food supplement and contracted food supplement.
• 2. Licensed food supplement shall be a food supplement which is manufactured in Indonesia under license.
• 3. Contracted food supplement shall be food supplement drugs whose manufacturing is delegated to the pharmaceutical industries, traditional drug industry or food industry under contract.
• 4. Import food supplement shall be food supplement produced by industry abroad, which imported and circulated in Indonesia.
• 5. The circulation licence shall be a form of approval of registration of food supplement given by the Agency Head to be circulated within the territory of Indonesia.
• 6. Contract grantors shall be an industry or a business entity in food supplement sector that delegate/authorizes the manufacture of food supplement on a contract basis.
• 7. Contract recipients shall be a pharmaceutical industry, traditional drug industry or food industry which receives the job of food supplement manufacturing on a contract basis.
• 8. Floppy disk shall be specific formatted disk for food supplement registrations.
• 9. Form shall be a food supplement registration form.
• 10. Variation shall be a change to any aspect of food supplement including but not limited to the change in formulation, method, industry, production site, specifications of ingredients and finished products, container, packaging and marking.
• 11. Formula shall be a qualitative and quantitative composition of main ingredients and additives.
• 12. Batch shall be a number of food supplement products that are manufactured in one manufacturing cycle that have uniform characteristics and quality.
• 13. Agency Head shall be the Head of National Agency of Drug and Food Control.
• 14. Deputy shall be the Deputy of Supervision Section of Traditional Drug, Cosmetic and Complement Product of the National Agency of Drug and Food Control.

CHAPTER II
REGISTRANT

First Part
Registrants of Domestic Food Supplement

Article 2

(1) Registrants of domestic food supplement consist of:

• a. registrant of unlicensed food supplement;
• b. registrant of licensed food supplement;
• c. registrant of contracted food supplement.

(2) Registrant of unlicensed food supplement as contemplated in paragraph (1) letter a is a pharmaceutical industry or traditional drug industry or food industry.

(3) Registrant of licensed food supplement as contemplated in paragraph (1) letter b is a licensee that is a pharmaceutical industry or traditional drug industry or food industry.

(4) Registrant of contracted food supplement as contemplated in paragraph (1) letter c is the contract grantor which is a pharmaceutical industry or traditional drug industry or food industry or business entity in food supplement marketing sector.

(5) Pharmaceutical industry or traditional drug industry or food industry or business entity in food supplement marketing sector as contemplated in paragraph (4) is obliged to possess at least a quality testing laboratory with a pharmacist as its person responsible.

Second Part
Registrant of Imported Food Supplement

Article 3

(1) Registrant of imported food supplement is a pharmaceutical industry or traditional drug industry or food industry or business entity in food supplement marketing sector that receives appointment letter directly for the industry in the country origin.

(2) Industry or business entity as contemplated in paragraph (1) is obliged to possess importer license in pharmaceutical preparation sector.

(3) Industry that produces food supplement in the country origin is obliged to meet requirements of Good Manufacturing Procedures (GMP) proven with certification issued by the competent government authority in the country origin or an accredited certification institution or if necessary, in situ examination van be conducted by an officer of the National Agency of Food And Drug Control.

Third Part
Registrants of Patent Protected Food Supplement

Article 4

(1) Registrant of patent protected food supplement in Indonesia is a pharmaceutical industry or traditional drug industry or food industry or business entity in food supplement marketing sector as patent right holder or the appointee of patent right owner or the assignee of patent right holder in accordance with the prevailing provisions.

(2) Patent right as contemplated in paragraph (1) must be proven with patent certificate.

(3) Patent assignment as contemplated in paragraph (1) must be proven with the patent right transfer in accordance with the prevailing provisions.

Fourth Part
Responsibilities of the Registrant

Article 5

Registrant is responsible for:

• a. completeness of documents submitted;
• b. correctness of all information contained in the registration documents;
• c. correctness and validity of documents attached for the completeness of registration;
• d. change in data and information of product that is under registration process or that has obtained circulation license.

CHAPTER III
REGISTRATION CATEGORY

Article 6

(1) Food supplement registration is categorized into new registration and variation registration.

(2) New registration as contemplated in paragraph (1) consists of:

• a. category 1: registration of food supplement that contains one or more materials in the form of vitamin, mineral, amino acid, carbohydrate, protein, fat or other materials in the form of isolate;
• b. category 2: registration of food supplement that contains one or more materials in the form of vitamin, mineral, amino acid, carbohydrate, protein, fat, other isolates, and other materials in the form of natural materials;
• c. category 3: registration of food supplements of categories 1 and 2 with a claim of new usage, new preparation form, posology and new dosage.

(3) Variation registration as contemplated in paragraph (1) consists of:

• a. category 4: registration of food supplement that has obtained circulation license with:
• 4.1. change of product name without change of composition;
• 4.2. change or increase of package size;
• 4.3. change of claim in the marking that dose not change the benefits;
• 4.4. change of package design;
• 4.5. change of factory name or licenser name without change of ownership status;
• 4.6. change of importer name, without change of ownership status.
• b. category 5: registration of food supplement hat has obtained circulation license with:
• 5.1. change of specification and or analysis method of raw materials;
• 5.2. change of specification and or analysis method of finished product;
• 5.3. change of stability;
• 5.4. change of production technology;
• 5.5. change of production site;
• 5.6. change or increase of package type.
• c. category 6: registration of food supplement that has obtained circulation license with:
• 6.1. change of formula or composition whose main ingredients are categorized in one group;
• 6.2. change of additive that does not change the benefits.

CHAPTER IV
PROCEDURES TO OBTAIN CIRCULATION LICENSE

First Part
Registration

Article 7

(1) Registration is submitted by the registrant to the Agency Head.

(2) Registration of food supplement is conducted in 2 (two) stages, namely pre assessment and assessment.

(3) Pre assessment as contemplated in paragraph (2) is a stage of examination on completeness, validity of documents and the category is determined as contemplated in Article 6.

(4) Assessment as contemplated in paragraph (2) is an evaluation process to the documents and the supporting data.

Article 8

(1) Result of the pre assessment is notified in writing to the registrant and is final and binding in nature.

(2) Results of the pre assessment as contemplated in paragraph (1) is notified not later than 10 (ten) working days for a variation registration and 20 (twenty) working days for an new registration as from the date of receipt of registration dossiers.

Article 9

Data and anything that relates to the assessment in the framework of registration shall be kept confidential by the Agency Head.

Article 10

On the registration, a charge is imposed in accordance with the prevailing statutory regulations.

Article 11

(1) Submission of registration is conducted by presenting registration dossiers consisting of completed registration form or floppy disk, furnished with administrative documents and supporting documents.

(2) The administrative documents as contemplated in paragraph (1) are as specified in Attachment 1.

(3) The registration form or floppy disk is provided by the National Agency of Food And Drug Control.

Article 12

(1) The supporting documents of food supplement as contemplated in Article 11 paragraph (1) consist of:

• a. documents of quality and technology as per Attachment 2;
• b. documents that support effectiveness claim in accordance with the type and level of proofing.

(2) Guidelines for effectiveness claim as contemplated in paragraph (1) point b shall be stipulated separately.

Article 13

(1) Registration dossiers as contemplated in Article 11 paragraph (1) must be furnished with:

• a. package design including etiquette, box, wrapping, strip, blister, catch cover, and other packages in accordance with the prevailing provisions on wrapping and marking, that constitutes package design of food supplement that will be circulated and must be completed with color design;
• b. brochures that mention information on the food supplement.

(2) The information must at least be mentioned in the package design and brochures as contemplated in paragraph (1) as per Attachment 3.

Article 14

Registration of contracted food supplement, licensed food supplement and imported food supplement, in addition to being required to meet provisions in regulation on food supplement registration, must also meet the provisions as specified in Attachment 4.

Article 15

(1) For a new registration as contemplated in Article 6 paragraph (2), the dossiers to be presented as per Attachment 5 consist of:

• a. SA form containing information on administrative documents;
• b. SB form containing documents that include formula and manufacturing method;
• c. SC form containing documents that include method of quality examination of raw materials and finished product;
• d. SD form containing documents that include claim of usage, method of use and batch.

(2) For a variation registration as contemplated in Article 6 paragraph (3), dossiers to be presented consist of variation registration form as per Attachment 6 and completeness of variation registration for each category as per Attachment 7.

Second Part
Completion of Form

Article 16

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

• a. completion of registration form must use bahasa Indonesia and or English;
• b. registration documents may use bahasa Indonesia and or English;
• c. marking of domestic food supplement must use bahasa Indonesia;
• d. marking of imported food supplement must use bahasa Indonesia beside its original language.

(2) Direction of completion of new registration form is as per Attachment 8.

Third Part
Assessment

Article 17

(1) On the registration documents of food supplement that has met provisions as contemplated in Article 10 and Article 11 in this Regulation, assessment is conducted in accordance with provisions as contemplated in Article 4 in the Decision of the Head of National Agency of Food And Drug Control on Basic Provisions of Food Supplement Control.

(2) The assessment is implemented through:

• a. channel 1: 1.1. for food supplements category 1 that use generic name;
  1.2. for food supplements category 4;
• b. channel 2: 2.1. for food supplements category 1 that use trade name;
  2.2. for food supplements category 5;
• c. channel 3: 3.1. for food supplements category 2 with safety profile has been known in certainty;
  3.2. for food supplement category 6;
• d. channel 4: for food supplement category 2 with safety profile has not been known in certainty and category 3.

Article 18

(1) In order to conduct assessment as contemplated in Article 17, Appraisal Committee for Food Supplement (PPSM) and National Committee for Food Supplement Assessment (KOMNAS PSM) arte established.

(2) establishment, duties and functions of the PPSM as contemplated in paragraph (1) shall be stipulated by the Deputy.

(3) establishment, duties and functions of the KOMNAS PSM as contemplated in paragraph (1) shall be stipulated by the Agency Head.

Article 19

Results of assessment of quality, safety and efficacy can be compliance, not yet compliance or incompliance.

Fourth Part
Award of Decision

Article 20

In case of compliance as contemplated in Article 19, the Agency Head shall issue a decision letter of registration approval by using format as per Attachment 9.

Article 21

(1) In case of not yet compliance as contemplated in Article 19, additional data are required that will be notified in writing by using format as per Attachment 10.

(2) Registrant who has received request for additional data as contemplated in paragraph (1) is obliged:

• a. to submit the additional data not later than 3 (three) months as of the notice date;
• b. if the time limit of 3 (three) months as contemplated in letter a elapses, the registration dossiers are returned by mail as per Attachment 11;
• c. the returned dossiers as contemplated in letter b can be resubmitted as a new registration and completed with the additional data as contemplated in paragraph (1).

Article 22

In case of incompliance as contemplated in Article 19, the Agency Head shall issue a decision letter by using format as per Attachment 12.

Article 23

Decision on the assessment results shall be awarded as from the receipt of complete registration dossiers accompanied with payment evidences as contemplated in Article 10 not later than:

• a. registration channel 1 (one): 7 working days;
• b. registration channel 2 (two): 15 working days;
• c. registration channel 3 (three): 30 working days;
• d. registration channel 4 (four): 60 working days.

Fifth Part
Hearing

Article 24

(1) To the not yet compliance decision as contemplated in Article 21 or incompliance decision as contemplated in Article 22, the registrant may submit objection in writing by using the hearing mechanism to the Agency Head.

(2) The objection as contemplated in paragraph (1), shall be submitted not later than 30 (thirty) working days as of the decision letter date.

Sixth Part
Review

Article 25

(1) Based on results of the hearing as contemplated in Article 24, a review can be filed against the results of assessment.

(2) In case of review as contemplated in paragraph (1), the registrant must complete with new data and or data that have ever been submitted accompanied with justification.

(3) Result of the review can be either approval or refusal of the justification submitted.

Seventh Part
Registration Approval

Article 26

Approval of food supplement registration is valid for 5 (five) years as long as still meeting the prevailing provisions and can be extended through re-registration.

CHAPTER V
IMPLEMENTATION OF CIRCULATION LICENSE

Article 27

(1) Registrant is obliged to produce or import the food supplement that has obtained circulation license not later than 1 (one) year as of the issuance date of circulation license.

(2) Registrant must submit ready for circulation package to the Agency Head not later than 1 (one) month before the food supplement is produced or imported.

(3) Registrant is obliged to report the information on production or importation activities periodically every 6 (six) months to the Agency Head.

CHAPTER VI
REASSESSMENT

Article 28

(1) To the food supplement that has circulation license, reassessment can be conducted by the Agency Head.

(2) Reassessment as contemplated in paragraph (1) is conducted if there is any new data and or information relating to quality, safety and efficacy of that affects the community health.

CHAPTER VII
REVOCATION

Article 29

(1) the Agency Head may revoke the circulation license of food supplement in the event:

• a. based on researches and observation after circulation, the food supplement fails to meet criteria as contemplated in the Basic Provisions of Food Supplement Control Article 4 or;
• b. the marking does not comply with the approved or;
• c. the promotions departs from the prevailing provisions or;
• d. fails to perform obligations as contemplated in Article 27;
• e. the food supplement is not produced or imported for 2 (two) years successively or;
• f. the pharmaceutical industry license or traditional drug industry license or food industry license or business entity license is revoked or;
• g. the circulation license holder commits in violation in production or importation of food supplement.

(2) Revocation of the circulation license as contemplated in paragraph (1) shall be conducted by the Agency Head by using format as per Attachment 13.

CHAPTER VIII
SANCTIONS

Article 30

(1) Violation to any provisions in this decision shall be subjected to administrative sanctions in the form of:

• a. Written warning;
• b. Withdrawal of the food supplement from circulation IBCL advertisement withdrawal;
• c. Suspension of food supplement production, import and distribution, storage, transportation and delivery activities;
• d. Circulation license freezing or revocation.

(2) In addition to administrative sanctions as contemplated in paragraph (1), criminal sanction shall be applied in accordance with the prevailing statutory regulations.

CHAPTER IX
TRANSITIONAL PROVISION

Article 31

(1) All regulations that have been issued before this decision is stipulated shall remain valid as long as not in contradictory to this decision.

(2) Food supplements which have possessed circulation license before stipulation of this decision are obliged to make adjustment not later than 2 (two) years as of this decision is stipulated.

CHAPTER X
CLOSING PROVISION

Article 32

(1) Any technical matters that have not been regulated sufficiently in this decision will be regulated further.

(2) This decision shall come to effect as of the stipulation date.

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