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REGULATION OF THE HEAD OF DRUG AND FOOD CONTROLER AGENCY
NUMBER HK.03.1.23.10.11.08481 OF 2011

CONCERNING
CRITERIA AND PROCEDURE OF DRUG REGISTRATION

BY THE GRACE OF ALMIGHTY GOD
THE HEAD OF DRUG AND FOOD CONTROLER AGENCY,

Attachment

Considering:

a. that in order to protect the public from the drug that does not meet the requirements of efficacy, safety, and quality, it is necessary drug registration before the circulation;

b. that the provisions of the Criteria and Procedure of Drug Registration as governed by Decree of the Head of Drug and Food Controller Agency Number HK.00.05.3.1950 of 2003 concerning the Criteria and Procedure of Drug Registration is no longer relevant to the development of science and technology;

c. that based on considerations as intended in paragraphs a and b, and to implement the provisions of Article 14 paragraph (2) of Regulation of the Minister of Health Number 1010/Menkes/Per/XI/2008 concerning Drug Registration as amended by the Regulation of the Minister of Health Number 1120/Menkes/Per/XII/2008 concerning the Amendment to the Regulation of the Minister of Health Number 1010/Menkes/Per/XI/2008 concerning Drug Registration and Article 36 paragraph (4) of Law Number 35 of 2009 concerning Narcotics, it is necessary to stipulate Regulation of the Head of Drug and Food Controller Agency of Criteria and Drug Registration Procedure;

In view of:

1. Prescription Drugs Ordinance (Statute Book Number 419 of 1949);

2. Law Number 5 of 1997 concerning Psychotropic (Statute Book of the Republic of Indonesia Number 10 of 1997, Supplement to Statute Book of the Republic of Indonesia Number 3671);

3. Law Number 8 of 1999 concerning Consumer Protection (Statute Book of the Republic of Indonesia Number 42 of 1999, Supplement to Statute Book of the Republic of Indonesia Number 3821);

4. Law Number 35 of 2009 concerning Narcotics (Statute Book of the Republic of Indonesia Number 143 of 2009, Supplement to Statute Book of the Republic of Indonesia Number 5062);

5. Law Number 36 of 2009 concerning Health (Statute Book of the Republic of Indonesia Number 144 of 2009, Supplement to Statute Book of the Republic of Indonesia Number 5063);

6. Government Regulation Number 72 of 1998 concerning Safety of Pharmaceutical Stock and Medical Devices (Statute Book of the Republic of Indonesia Number 138 of 1998, Supplement to Statute Book of the Republic of Indonesia Number 3781);

7. Presidential Decree Number 103 of 2001 concerning the Status, Duties, Functions, Authority, Organizational Structure, and Work Flow of Non Ministerial Government Agencies as amended several times, the latest by Presidential Decree Number 64 of 2005;

8. Presidential Decree Number 110 of 2001 concerning the Organizational Unit and Task of First Echelon of Non Ministerial Government Agencies as amended by Decree of the President of the Republic of Indonesia Number 52 of 2005;

9. Regulation of the Minister of Health Number 1010/Menkes/Per/XI/2008 concerning Drug Registration as amended by Regulation of the Minister of Health Number 1120/Menkes/Per/XII/2008;

10. Regulation of the Minister of Health Number 1799/Menkes/Per/XII/2010 concerning the Pharmaceutical Industry;

11. Decree of the Head of Drug and Food Controller Agency Number 02001/SK/KBPOM of 2001 concerning the Organization and Administration of Drug and Food Controller Agency as amended by the Decree of the Head of Drug and Food Controller Agency Number HK.00.05.21.4231 of 2004;

12. Decree of the Head of Drug and Food Controller Agency Number HK.00.05.3.0027 of 2006 concerning the Implementation Guidelines for Good Drug Manufacturing Practice, as amended by the Decree of the Head of Drug and Food Controller Agency Number HK.03.1.23.09.10.9030 of 2010;

13. Decree of the Head of the Drug and Food Controller Agency Number HK.00.05.3.2522 of 2003 concerning Guidelines for Good Drug Distribution Method;

DECIDES:

To stipulate:

REGULATION OF THE HEAD OF DRUG AND FOOD CONTROLER AGENCY CONCERNING CRITERIA AND PROCEDURE OF DRUG REGISTRATION

CHAPTER I
GENERAL PROVISIONS

Article 1

In this Regulation:

1. Formula is a qualitative and quantitative composition of active substances and additives in the drug.

2. Form is a registration form of drug.

3. Day is a work day.

4. Pharmaceutical Industry is a business entity that has a permit from the Minister of Health to conduct the manufacture of drugs or drug ingredients.

5. Domestic Pharmaceutical Industry is pharmaceutical industry is located in the territory of Indonesia, which has a license from the Minister of Health.

6. Product information is complete information on the drug approved by POM agency, including efficacy, safety, how to use it, as well as other necessary information attached in the summary of product characteristics and product information for patients/brochures.

7. Product Information for the Patient is information for patients who are approved by POM Agency related to efficacy, safety, and how to use the drug as well as any other information deemed necessary by using the Indonesian language easily understood by the patient.

8. Distribution Permit is a form of drug registration approval to be distributed in territory of Indonesia.

9. Dosage strength is the level of active ingredient in the drug.

10. The composition is a qualitative and quantitative composition of active substances in drugs.

11. Contraception is a drug or device containing drug the intended to prevent conception.

12. License is a transfer of rights and authorized the use of the results of research and development related to efficacy, safety, quality, and transfer of technology in the manufacture and/or use of trade names and sale of a drug.

13. Narcotics are substances or drugs derived from plants or non plants, either synthetic or semi-synthetic, which can cause degradation or alteration of consciousness, loss of taste, reduce to eliminate pain, and can lead to dependence, which is divided into groups as governed by Law concerning Narcotics.

14. Drug are medicines including biological products, which is a material or combination of materials used to influence or to investigate physiological systems or pathological conditions in the framework of establishment of diagnosis, prevention, healing, restoration and improvement of health, and contraception for human.

15. New Drug is a drug with a new active ingredient, new additive substances, form of the dosage/ new administration route, a new power, or new combinations that have not been approved in Indonesia.

16. Copy drug is a medicine containing the active substance with the composition, strength, dosage form, way of giving, indications, and posology; similar to drugs already approved.

17. Imported drug is drug made by the pharmaceutical industry abroad in the form of finished products or bulk products in primary packaging that will be circulated in Indonesia.

18. Contract drug is a drug manufacturing is delegated to another pharmaceutical industry.

19. License drug is a drug made by the domestic pharmaceutical industry under license.

20. Domestic drug production is a drug primary manufactured and/or packaged by the pharmaceutical industry in Indonesia.

21. The drug is Patent Protected is drug already get patent protection by the effective Patent Law in Indonesia.

22. The Contracting Given is pharmaceutical industry that delegate drug manufacturing work based on contract.

23. Licensor is a pharmaceutical industry or research agency owner of formula and technology inside or outside the country that gives license to the registrant drug pharmaceutical.

24. Owner of Distribution Permit is the registrant has received distribution permit for the drug registered.

25. Marking is the information contained on the label/packaging label.

26. Applicant is a pharmaceutical industry that has received permission in accordance with the pharmaceutical industry regulation.

27. Contract Recipient is pharmaceutical industry receive drug manufacturing work under the contract.

28. Biological products are vaccines, immunizer, antigens, hormones, enzymes, blood products and other fermentation products (including monoclonal antibodies and products derived from recombinant DNA technology) are used to influence or to investigate the physiology or pathology system in the framework to prevent, cure, recovery and improved health.

29. Finished product is a product that has pass through all stages of the manufacturing process.

30. Bulk product is a material that has completed processing and just need packaging activities to become drug.

31. Psychotropic is substances or drugs, either natural or synthetic non narcotic, is efficacious psychoactive through selective effects on the central nervous system that causes typical changes in mental activity and behavior.

32. Registration is the procedure of registration and evaluation of the drug to obtain distribution permit.

33. New Registration is drug registration that has not received distribution permit in Indonesia.

34. Re-registration is a renewal registration of the distribution permit.

35. Variations Registration is registration on the change any aspect of drug that has distribution permit in Indonesia, including but not limited to changes in formulation, method, process, specifications for drug and raw materials, containers, packaging and labeling.

36. Major Variations Registration (VaMa) is registration of variation affecting to the aspect of efficacy, safety, and/or quality of the drug.

37. Minor Variations Registration that Requiring Approval (VaMi-B) is registration of variation does not include the category of minor variations registration with notification of major variations.

38. Minor Variation Registration with Notification (VaMi-A) is registration of variation that minimal effect or no effect at all of the aspects of the efficacy, safety, and/or quality of the drug, and does not change the information on the distribution permit.

39. Summary of Product Characteristics is comprehensive information approved by the relevant POM agency related with description of drug efficacy and safety of data from clinical trial results, and other information deemed necessary and serves as a source of information for health workers and become the reference in the preparation of product information for patients.

40. Other preparations that containing drug are products containing a drug with special technology, including but not limited to transdermal patches, implants, and beads.

41. Similar Biotherapeutic Product (SBP) or Similar Biological Products (PBS) are biological products with similar profile of efficacy, safety, and quality with biological products that have been approved.

42. Site Master File or pharmaceutical industry master documents, hereinafter abbreviated as SMF is a document that contains specific information on the quality assurance, production, and/or quality control of drug manufacturing process carried out at the location and related activities in the surrounding buildings.

43. Stinel (Electronic Information Standards) is complete standard information on drug efficacy, safety, how to use, and other information that must be listed on the Product Information.

44. Active substances are components of drugs that have pharmacological effects.

45. Additional substance is of the drug components is intended as fillers, solvents, coatings, helper, propellants and substance that are intended to enhance the usability, stability, durability or as a dye and have no pharmacological effects.

46. Head of Agency is the Head of the Agency who is responsible for the Food and Drug Control.

CHAPTER II
DRUG CRITERIA

Article 2

(1) The drug will be distributed in Indonesia must has distribution permit.

(2) To obtain the distribution permit as intended in paragraph (1) must be made registration.

(3) Drug registration is applied to the Head of Agency by the Registrant.

Article 3

Drugs that will have a distribution permit must meet the following criteria:

Article 4

(1) Contraception for national programs as intended in Article 3 paragraph e by the determination by the government agency that administer the family planning affairs.

(2) Other national program drugs as intended in Article 3 paragraph e are based on the determination by the government agency that administer health affairs.

CHAPTER III
DRUG REGISTRATION CATEGORIES

Article 5

(1) Drug registration shall consist of:

(2) New registration as intended in paragraph (1) a shall consist of:

(3) Variety Registration as intended in paragraph (1) b shall consist of:

(4) Re-registration as intended in paragraph (1)c, namely:

CHAPTER IV
REGISTRATION REQUIREMENTS

Part One
Drug Name

Article 6

(1) Name of drug that be registered may use:

(2) The generic name as intended in paragraph (1) a appropriate with Pharmacopoeia Indonesia or appropriate with International Non-proprietary Names (INN) are determined by World Health Organization (WHO).

(3) Trade names as intended in paragraph (1) b, which is the name given by the Registrant to the identity of the drug.

(4) Provision of trade name as intended in paragraph (1) b based on self assessment (self-assessment) and the responsibility of the Applicant.

(5) self assessment as intended in paragraph (4) at least has to pay attention to the following provisions:

(6) The trade name of free drug and unlimited free drug containing at least one of the same active substance and/or the same therapeutic class can use same trade name as group name.

(7) If in the future there are other parties who have more right to the name of the drug contained in the authorization in accordance with laws and regulations, the applicants are willing to change the name of the drug.

Part Two
Registration

Article 7

(1) Registrant register drug by submits registration documents.

(2) The drugs that can be registered:

(3) Domestic Production drugs as intended in paragraph (2) a, may be in the form of:

(4) Domestic Production drugs as intended in paragraph (3) may be circulated in the domestic and/or export purposes.

(5) Import drugs as intended in paragraph (2) b may be in the form of:

(6) Import Drugs as intended in paragraph (5) can be circulated in the domestic and/or export purposes.

Part Three
Drug Registration of Domestic Production

Article 8

(1) Drug Registration of Domestic Production by Registrant must meet the following requirements:

(2) Excepted from the provisions as intended in paragraph (1) a and b, to candidate of pharmaceutical industry who is developing or pharmaceutical industry will expand production facilities, registration requirements may be a result of inspection of the implementation of the development.

(3) In the case of registrations made based on the provisions of paragraph (2), the distribution permit number will be issued after the candidate of pharmaceutical industry meets the requirements as intended in paragraph (1).

Part Four
Registration of Domestic Production Drug Based on License

Article 9

(1) Registration of Domestic Production Drug Based on License is conducted by license receiver as Registrant.

(2) Registration as intended in paragraph (1) shall also comply with the provisions as intended in Article 8 paragraph (1) and has a license agreement document.

(3) license agreement document as intended in paragraph (2) shall contain at least:

(4) The licensor may in form of:

(5) The licensor as intended in paragraph (4) must have proof of status as the pharmaceutical industry or research agency.

(6) The owner of a distribution permit for the Domestic Production drug based on license is the registrant pharmaceutical industry.

Part Five
Registration Domestic Production Drug Based on Contract

Article 10

(1) Registration of the domestic production drug based on contract can only be made by the contracting as a Registrant.

(2) Registrant as intended in paragraph (1) must also comply the following requirements:

Article 11

(1) Manufacturing of domestic production drug based on the contract can be:

(2) Formula of domestic production drug based on the contract can be:

(3) Contracting Pharmaceutical Industry and receiving the contract Pharmaceutical Industry are responsible for aspects of the efficacy, safety, and quality of the contracted drug, with the primary responsibility is pharmaceutical industry as contracting as the owner of the distribution permit.

(4) Receiving of contract may not transfer contracted drug manufacturing to a third party of the Pharmaceutical Industry.

Part Six
Imported Drug Registration

Article 12

Imported drug preferred for:

Article 13

Drug for public health programs as intended in Article 12 a based on determination by healthy program.

Article 14

(1) the discovery of new drug as intended in Article 12 b shall consist of:

(2) Originator drug as intended in paragraph (1) b is:

Article 15

(1) Drug needed but can not be produced domestically as intended in Article 12 c may be in the form of:

(2) Imported Drug Registration as intended in paragraph (1) shall be equipped with justification that the drug can not be produced in Indonesia.

Article 16

(1) Imported Drug Registration can only be done by the Registrant after obtain written approval of pharmaceutical industry abroad.

(2) The pharmaceutical industry abroad as intended in paragraph (1) shall has a permit of pharmaceutical industry and CPOB requirements as evidenced by:

(3) In addition to the provisions as intended in paragraph (2), applicants must submit new SMP documents if:

(4) In the case of Imported Drugs as intended in paragraph (1) stages of manufacture carried out by more than 1 (one) pharmaceutical industries abroad, so all stages of manufacturing must meet the requirements as intended in paragraph (2).

(5) Exception from the provisions as intended in paragraph (3) for Imported Drug Registration of the same production facilities and the same dosage form that has been approved in Indonesia.

(6) If the evaluation of SMF document requires proof of the fulfillment of the requirements of CPOB, it will be the local examination.

Article 17

(1) Imported Drug Registration as intended in Article 15 paragraph (1) should be done gradually transfer the technology to be produced domestically.

(2) The transfer of technology as intended in paragraph (1), including but not limited to the transfer of knowledge/skills in the fields of:

(3) The transfer of technology as intended in paragraph (1) may be given to the representatives of the pharmaceutical industry in Indonesia or other pharmaceutical industry in Indonesia by agreement between the owner and the receiver technology.

Part Seven
Narcotic Drug Registration

Article 18

(1) Registration of narcotic drug can only be made by Registrant that has special permit to produce narcotics from the Ministry of Health.

(2) Registration of narcotic drug as intended in paragraph (1) is implemented in accordance with the terms and procedures as intended in the criteria and procedure are governed in this regulation.

Part Eight
Registration of Drug specialized for Export

Article 19

(1) Registration of drug specialized for export is made by Registrant.

(2) Registration of drug specialized for export as intended in paragraph (1) shall consist of:

(3) Applicants for registration as intended in paragraph (2) a shall comply with the provisions as intended in Article 8 paragraph (1).

(4) Applicants for registration as intended in paragraph (2) b shall comply with the provisions as intended in Article 16 paragraph (1).

(5) Drug specially for export as intended in paragraph (2) is prohibited to be circulated in Indonesia.

Part Nine
Registration of Patent Protected Drug

Article 20

(1) Registration of drug with efficacious substance that is patent protected in Indonesia can only be done by the owner of the patent Applicant or Applicant appointed by the owner of the patent.

(2) The patent right as intended in paragraph (1) shall be evidenced by a certificate of patents.

Article 21

(1) Registration of drug with efficacious substances that is still patent protected in Indonesia can be done by the Applicant is not the owner of the patent in accordance with regulations.

(2) Registration as intended in paragraph (1) may be made from 2 (two) years prior to the expiration of patent protection.

(3) Registration as intended in paragraph (2) shall meet the following requirements:

(4) Special registration as intended in paragraph (2), after fulfilling the requirements of efficacy, safety, and quality will be given a temporary approval letter, and distribution permit number will be given after the expiration of patent protection.

CHAPTER V
DRUG REGISTRATION PROCEDURE

Part One
General

Article 22

(1) Drug registration shall be made after the pre-registration.

(2) Application of pre-registration and registration filed by the Registrant in writing to the Head of Agency attached with pre-registration or registration documents.

(3) Registration document as intended in paragraph (2) are prepared in accordance Format of ASEAN Common Technical Dossier (ACTD).

(4) The application as intended in paragraph (2) shall be submitted by filling out the form according to the sample in Attachment I that is an integral part of this Regulation.

(5) Instructions on filling in the form as intended in paragraph (2) are listed in Attachment II that is an integral part of this Regulation.

(6) The application for pre-registration and registration are charged a non-tax state revenue in accordance with the provisions of the regulation.

(7) Application for pre-registration and registration can be filed electronically.

Paragraph One
Registration Document

Article 23

(1) The registration document as intended in Article 22 paragraph (2) shall consist of:

(2) Pre-registration and registration documents must use Indonesian language or English.

(3) Registration document as intended in paragraph (1) in according to the sample Attachment III that is an integral part of this Regulation.

(4) The procedure for the preparation of the registration document as intended in paragraph (1) in accordance with Attachment IV that is an integral part of this Regulation.

(5) The registration document as intended in paragraph (1) is a confidential document that is used only for evaluation purposes by the authorities party.

Article 24

(1) Administrative documents as intended in Article 23 paragraph (1) a shall in according to the sample in Attachment V that is an integral part of this Regulation.

(2) Product Information Document as intended in Article 23 paragraph (1) a shall consist of:

(3) Marking documents as intended in Article 23 paragraph (1) a cover etiquette/label, strip/blister, ampoule/vial, catch cover/envelope, and the outer wrap.

(4) Product Information for patients as intended in paragraph (2) b and marking documents as intended in paragraph (3) shall use the Indonesian language, Arabic numerals and Latin letters.

(5) The use of a language other than Indonesian language in the product information for patients and marking documents as intended in paragraph (4) can be done as long as no equivalent in the Indonesian language.

(6) In addition to using the Indonesian language as intended in paragraph (4), Product Information can be added to a language other than Indonesian language in accordance with the approved information.

(7) Product Information for Patients as intended in paragraph (2) b, when devoted to free drug and limited free drug group should be included on the packaging of the smallest, can be a brochure, catch cover/envelope, or blister.

(8) Exempted from the provisions as intended in paragraph (4), paragraph (5), (6), and paragraph (7) are for the drugs special for export.

(9) Minimum information that must be included in the Product Information document as intended in paragraph (2) are in accordance with Attachment VI that is an integral part of this Regulation.

(10) Minimum information that must be included in the marking as intended in paragraph (3) are in according to Attachment VII that is an integral part of this Regulation.

Article 25

(1) Quality documents as intended in Article 23 paragraph (1) b are in according to Attachment VIII that is an integral part of this Regulation.

(2) Non-clinical documents as intended in Article 23 paragraph (1) c are in according to Attachment IX that is an integral part of this Regulation.

(3) Clinical documents as intended in Article 23 paragraph (1) d are in according to Attachment X that is an integral part of this Regulation.

Second paragraph
Responsibility of Applicant

Article 26

(1) Applicant is responsible for:

(2) The responsibility of Registrant as intended in paragraph (1) shall be stated in writing in the statement letter in according to the sample in Attachment XI that is an integral part of this Regulation.

(3) Any change in the data and/or the Product Information as intended in paragraph (1) c must be approved by the Head of the Agency.

Part Two
New Development Drug Process

Article 27

(1) The drug is made and through the clinical trials phases in Indonesia before it is registered should through the assessment process of new development drug.

(2) Evaluation of new development drug process as intended in paragraph (1) shall be governed separately by the Head of the Agency.

Part Three
Pre-registration

Article 28

(1) Application for the per-registration of drug is for screening drug registration, determination of registration category, determination of evaluation point, evaluation cost and determination of drug registration documents.

(2) The application as intended in paragraph (1) shall be filed with:

Article 29

(1) No later than 40 (forty) days of receipt of the application as intended in Article 28 paragraph (1), the Head of Agency submit letter of Pre-Registration (HPR) result to the applicant.

(2) HPR valid for 1 (one) year from the date of issuance.

(3) HPR as intended in paragraph (1) shall be final and binding.

(4) If prior to the period as intended in paragraph (1) required the addition of data over administrative and/or technical documents then the Applicant will be given a letter for requesting additional data.

(5) In case of the Applicant be given letter for requesting additional data as intended in paragraph (4), the calculation of the period as intended in paragraph (1) is stopped (clock off) until the Registrant submit additional requested data.

(6) At the latest 20 (twenty) days after the date of the letter of request additional data, the registrant must submit additional data.

(7) In case Applicants unable to submit additional data within a period of 20 (twenty) days as intended in paragraph (6), then the application is rejected and the pre-registration fees already paid will not be refunded.

Article 30

Exempted from the provisions of Article 28 to Registration of drug Variation in category 5 and category 6 as intended in Article 5 paragraph (3) b and c, and Re-Registration of category 7 as intended in Article 5 paragraph (4).

Part Four
Evaluation Line

Article 31

Evaluation line as intended in Article 28 paragraph (1) shall consist of:

1. Line of 40 (forty) days include:

2. Line of 100 (one hundred) days include:

3. Line of 150 (one hundred fifty) days include:

4. Line of 300 (three hundred) days includes a new registration of New Drugs, Biological Products, similar Biological Products, or registration of major variations of new indications/posology that are not included in the evaluation lines as intended in paragraphs 2 and 3.

Part Five
New Registration

Article 32

(1) Application for New Registration shall be filed by the Registrant that meet the provisions as intended in Article 22 to Article 26 and Article 28 through Article 31.

(2) Application for New Registration as intended in paragraph (1) shall be submitted by filling out the form as in the sample in Attachment I and attach documents of New Registration.

(3) Completeness New Registration documents as intended in paragraph (2) in accordance Attachment XIII that is an integral part of this Regulation.

(4) Excluded from the provisions as intended in paragraph (3) for the registration of drugs for Export in accordance with the requirements in Attachment XIV that is an integral part of this Regulation.

(5) Registrant of special drug for export as intended in Article 19 paragraph (2) a can start export activities since the date of the submission registration document.

Article 33

(1) For the registration of drugs included in category 1, in addition to the completeness of the documents as intended in Article 32 paragraph (3), Applicant must also submit a risk management plan.

(2) Further provisions on the risk management plans as intended in paragraph (1) will be determined.

Part Six
Variation Registration

Article 34

(1) Changes to the drug has received distribution permit number must be reported to the Head of the Agency through Variation Registration mechanism.

(2) Application for Registration of variation as intended in paragraph (1) shall be submitted by filling out the form in according to sample in Attachment I and attach documents related to Variations Registration proposed changes.

(3) Type of change, and requirements documents for Variation Registration as intended in paragraph (2) are in according to Attachment XV that is an integral part of this Regulation.

Article 35

(1) Variation Registration of categories 6 as intended in Article 5 paragraph (3) c is applied by filling Form in according to sample in Attachment I and attach Variation Registration documents as intended in Article 34 paragraph (3).

(2) Applicants can begin to make changes as intended in paragraph (1) since the date of submission of Variation Registration documents.

(3) If the changes are proposed not in accordance with the types of changes that are listed in Attachment XV paragraph 3, the registration will be processed according to the Variation Registration category.

Part Seven
Re-Registration

Article 36

(1) Submission of application for re-registration is made at least 120 (one hundred twenty) days prior to the expiration of distribution permit validity period.

(2) Application for Re-registration as intended in paragraph (1) shall be submitted by filling out a form in according to sample in Attachment I and attaches Re-registration documents.

(3) Completed re-registration documents as intended in paragraph (2) are in accordance to Attachment XVI that is an integral part of this Regulation.

(4) Approval of the application for Re-registration as intended in paragraph (1) is automatically effective as of the end of distribution permit.

(5) Excluded from the provisions as intended in paragraph (4) for re-registration with the new information related to aspects of:

Article 37

(1) Application of the re-registration that is applied with certain changes, will be processed in accordance with the variation registration as intended in Article 34.

(2) Application for registration as intended in paragraph (1) shall be attached appropriate documents in according to Attachment XV.

Part Eight
Sample Drug

Article 38

Head of Agency may require the Applicant to provide sample drugs, drug ingredients, and reference standards as needed.

CHAPTER VI
EVALUATION AND GIVING DECISION

Part One
Evaluation

Article 39

(1) The registration documents which have been declared complete will be evaluated in according to criteria as intended in Article 3.

(2) The evaluation is conducted in accordance evaluation line as intended in Article 31.

(3) The time of the evaluation is according to the evaluation line as intended in paragraph (2), calculated from the submission of a complete registration documents.

Article 40

(1) To conduct an evaluation, it is established:

(2) Criteria, establishment, duties, and functions of KOMNAS of Drug Evaluation and Assessment Committee as intended in paragraph (1) shall be determined separately by the Head of Agency.

Article 41

(1) Evaluation of the efficacy and safety data are based on scientific evidence and guidelines for safety assessment by the Efficacy-Safety Assessment Team as intended in Article 40 paragraph (1) b.

(2) Based on the evaluation of the efficacy and safety of the data as intended in paragraph (1), KOMNAS of Drug Evaluation can provide recommendations to the Head of Agency.

(3) If necessary clarification and/or detailed technical explanation of the documents are submitted, KOMNAS of Drug Evaluation can recommend to a hearing with the Registrant.

(4) For the hearing as intended in paragraph (3), the Applicant submitted a notification in writing.

(5) The results of the evaluation of efficacy and safety as intended in paragraph (2) will be submitted to the Applicant in writing by the Head of the Agency no later than 30 (thirty) days.

Article 42

(1) Evaluation of quality data is conducted by the Committee on Quality Assessment criteria as intended in Article 3 paragraph (1) b based on the validity of documents and data inspection data of last CPOB.

(2) Information on the quality documents as intended in paragraph (1) shall use the same formula to be marketed and the manufacturing process has been validated.

(3) If necessary, to ensure the validity of the information documents as intended in paragraph (1) local examination in pharmaceutical manufacturing facilities (in-situ).

Article 43

Evaluation of Product Information and Marking conducted by Product Information and Marking Assessment Team to ensure that the information contained in the Product Information and Marking meet the criteria as intended in Article 3 c.

Article 44

(1) In case of additional data required, request for additional data is submitted to the Applicant in writing.

(2) Registrant must submit additional data as intended in paragraph (1) a maximum in one hundred (100) days after the date of requests for additional data.

(3) In terms of additional data required as intended in paragraph (1), the calculation time of the evaluation is stopped (clock-off).

(4) The calculation time of evaluation will be continued (clock-on) after Applicants submit additional data completely.

(5) In case of the Applicant can not meet the provisions as intended in paragraph (2), the Head of Agency will issued rejection of the registration.

Part Two
Giving Decisions

Article 45

(1) Decision of the Head of Agency to the registration of the drug is given with respect to:

(2) The decision as intended in paragraph (1) may include provision of approval or rejection.

(3) The approval as intended in paragraph (2) is only given to Registrant that fulfill administrative requirements and provisions as intended in Article 3.

(4) Rejection as intended in paragraph (2) is given otherwise comply with the provisions of Article 3.

Paragraph One
Approval

Article 46

(1) The approval as intended in Article 45 paragraph (3) notified to the Applicant in writing in the form of:

(2) Approval of Variation Registration in the form of distribution permit approval or letter of approval of the changes of distribution permit that has been issued.

(3) The approval as intended in paragraph (1) a use format in according to Attachment XVII that is an integral part of this Regulation.

Second paragraph
Rejection

Article 47

(1) The rejection of registration as intended in Article 45 paragraph (4) shall be submitted in writing by the Head of Agency in the form of Rejection Letter.

(2) In case the application for registration is rejected, the registration fee has been paid will not be refunded.

(3) Rejected registration as intended in paragraph (1), may be filed again by following the procedures as intended in Chapter V of Drug Registration Procedure.

(4) Rejection as intended in paragraph (1) by using a decision format in according with Attachment XVIII that is an integral part of this Regulation.

Part Three
Hearing

Article 48

(1) In the event that there is an objection to the results of the evaluation of the efficacy and safety by KOMNAS of Drug Evaluation as intended in Article 41 paragraph (2), Applicants may request a hearing in writing to the Head of Agency.

(2) The application as intended in paragraph (1) shall be filed at the latest a period of 20 (twenty) days from the date of notification of the results of the evaluation of efficacy and safety.

Part Four
Review

Article 49

(1) In case of there is an objection to the decision of registration in the form of rejection as intended in Article 47, Applicants may request review in writing to the Head of the Agency.

(2) The review as intended in paragraph (1) may be filed no later than 6 (six) months after the date of rejection and can only be done for 1 (once).

(3) The application for review must be accompanied by a new data and/or data that have already been filed with justification.

(4) Application for review may be filed in the form of hearings.

(5) Discussion on the application for review shall not exceed one hundred (100) days after received documents.

Part Five
Applying Re-Registration

Article 50

(1) In case the registration is rejected, Registrant may apply for re-registration in accordance with the provisions as intended in Chapter V of Drug Registration Procedure.

(2) In case the registration is rejected for some reason does not meet the criteria of efficacy and safety, in addition must follow the provisions as intended in paragraph (1), re-registration may be filed with the new data and after 1 (one) year after the date of the rejection letter.

CHAPTER VII
DISTRIBUTION PERMIT VALIDITY PERIOD

Article 51

(1) Drug Distribution Permit valid for maximum of 5 (five) years while meet effective regulations.

(2) Import Approval in the form of bulk, import approval for Export and approval for special Export apply at the latest 5 (five) years while meet effective regulations.

(3) Excepted from the provisions as intended in paragraphs (1) and (2) for the registration of drugs based on agreement/appointment with the cooperation period less than 5 (five) years, the period of distribution permit is in same with cooperation period in the agreement document.

(4) The drug has expired distribution permit can be extended while meet the criteria are governed in this regulation through the mechanism of Re-registration.

(5) Drug that has expired distribution permit and not renewed distribution permit declared as drug that does not have distribution permit.

Article 52

In case of the agreement/appointment as intended in Article 51 paragraph (3) is stopped before the distribution permit expires, the distribution permit of the drug I is declared canceled.

CHAPTER VIII
IMPLEMENTATION OF DISTRIBUTION PERMIT

Article 53

(1) Applicant shall produce or import, and distribute drugs that have received distribution permit no later than 1 (one) year after the date of approval issued.

(2) The obligation to produce or import, and distribute drugs as intended in paragraph (1) shall be reported by submitting a package ready for distribution to the Head of Agency.

(3) The import of drugs as intended in paragraph (2) conducted by the Pharmaceutical Industry Owner Distribution Permit.

(4) Pharmaceutical Industrial Owner Distribution Permit as intended in paragraph (3) may appoint another Pharmaceutical Industry or Pharmaceutical Wholesaler importer as the executor of drug importation.

(5) Packaging ready for distribution that is submitted as intended in paragraph (2) is in the form of primary packaging, secondary packaging, and Product Information.

(6) The delivery of packaging as intended in paragraph (2) shall not later than 1 (one) month prior to the implementation of the drug distribution.

Article 54

(1) The owner shall drug distribution permit monitor the efficacy, safety and quality of drugs during the drug is distributed and report to the Head of the Agency.

(2) Monitoring the efficacy, safety and quality of the drug for distribution as intended in paragraph (1) shall determined by itself.

CHAPTER IX
RE-EVALUATION

Article 55

(1) Any drug that has been granted distribution permit can be re-evaluated.

(2) Re-evaluation as intended in paragraph (1) if based on the results of monitoring carried out as intended in Article 54 paragraph (2) there are new developments on the different efficacy, safety, and quality drugs at the time of the supporting data of registration.

(3) The decision to re-evaluate the results as intended in paragraph (2) may be:

(4) The decision as intended in paragraph (3) shall be submitted in writing to the owner of a distribution permit for further action.

CHAPTER X
SANCTIONS

Article 56

Applicant who does not meet the provisions of Article 26, Article 53, and/or Article 54 may be subject to administrative sanctions in the form of:

Article 57

(1) Giving sanction in the form cancellation of drug registration process as intended in Article 56 b, if the information documents as intended in Article 42 paragraph (3) declared invalid.

(2) The sanction of frozen/cancellation of distribution permit as intended in Article 56 paragraphs c and d if the following occur:

(3) Exception from the provisions as intended in paragraph (2) b if it has reason in accordance with regulations.

(4) Frozen of distribution permit as intended in paragraph (2) shall be submitted in writing to the owner of a distribution permit in accordance with format in Attachment XIX that is an integral part of this Regulation.

(5) Cancellation of distribution permit as intended in paragraph (2) shall be submitted in writing to the owner of a distribution permit in accordance with format in Attachment XX that is an integral part of this Regulation.

CHAPTER XI
TRANSITIONAL PROVISIONS

Article 58

(1) Matters not provided for in this Regulation shall be further determined by the Head of Agency.

(2) When this Regulation comes into force, registration filed before the enforcement of this Regulation, it will be processed in accordance with the Decree of the Head of the Drug and Food Controller Agency Number HK.00.05.3.1950 of 2003 concerning Criteria and Procedure of Drug Registration.

CHAPTER XII
CLOSING RROVISION

Article 59

When this Regulation applies, Decree of Head of Drug and Food Controller Agency Number HK.00.05.3.1950 of 2003 concerning the Criteria and Procedure of Drug Registration shall be revoked and declared null and void.

Article 60

This Regulation comes into force on the date of promulgation.

So that everyone knows, it is ordered that this Regulation be promulgated in the Statute Book of the Republic of Indonesia.

Stipulated in Jakarta
on October 10, 2011
HEAD OF DRUG AND FOOD CONTROLLER AGENCY OF THE REPUBLIC OF INDONESIA,
signed,
KUSTANTINAH

Promulgated in Jakarta
on October 12, 2011
MINISTER OF LAW AND HUMAN RIGHTS OF REPUBLIC OF INDONESIA,
signed,
PATRIALIS AKBAR

STATE GAZETTE OF REPUBLIC OF INDONESIA NUMBER 634 OF 2011