DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL
No. HK.00.05.3.00914
CONCERNING
DRUG IMPORTATION THROUGH SPECIAL CHANNEL
THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL,
Considering:
- a. that for certain conditions, drugs are required for special therapeutic purposes the importation of which uses special channels without reducing guaranty of effectiveness, safety and quality of the drugs to the users.
- b. that in providing drugs as contemplated in letter a above, it is necessary to stipulate a Decision of the Head of National Agency of Drug and Food Control on Drug Importation through Special Channel.
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 Consumer Protection (Statute Book of 1999 No. 42, Supplement to Statute Book No. 3821);
- 6. Government Regulation No. 72/1998 on Safeguarding of Pharmaceutical Preparation and Medical Devices (Statute Book of 1998 No. 138, Supplement to Statute Book No. 3778);
- 7. Presidential Decree No. 103/2001 on Status, Duties, Functions, Authorities, Organisational Structure and Work Procedures of Non Departmental Government Institutions as amended by Presidential Decree No. 3/2002;
- 8. Presidential Decree No. 110/2001 on Organisation Unit and Duties of Echelon I in Non Departmental Government Institutions, as amended by Presidential Decree No. 5/2002;
- 9. Regulation of the Minister of Health No. 949/ MENKES/PER/VI/2000 dated June 26, 2000 on Registration of Finished Drug;
- 10. Decision of the Head of National Agency of Drug and Food Control No. 02002/SK/KBPOM dated February 28, 2001 on Clinical Test Procedure;
- 11. Decision of the Head of National Agency of Drug and Food Control No. 02001/SK/KBPOM dated February 26, 2001 on Organisation and Work Procedure of National Agency of Drug and Food Control.
DECIDES:
To stipulate:
DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL ON DRUG IMPORTATION THROUGH SPECIAL CHANNEL
CHAPTER I
GENERAL PROVISIONS
Article 1
Hereinafter referred to as:
- 1. Finished drugs or hereinafter referred to as 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.
- 2. Drug importation license for special therapeutic purpose is Clearance of Importation Approval that is issued by the National Agency of Drug and Food Control.
- 3. Importation is importation of drugs for special therapeutic purpose into territory of the Republic of Indonesia.
- 4. Pharmaceutical Industry shall be industry of finished drug and industry of drug raw materials that meet requirements in accordance with the prevailing law provisions.
- 5. Pharmaceutical Wholesaler (Pedagang Besar Farmasi) (PBF) shall be a Legal Entity of Limited Liability Company or Cooperative that possesses license for procurement, storage, distribution of pharmaceutical supplies in large quantity accordance with the prevailing law provisions.
- 6. Importer shall be pharmaceutical industry or pharmaceutical wholesaler.
- 7. Agency Head shall be the Head of National Agency of Drug and Food Control.
CHAPTER II
SPECIAL CHANNEL OF DRUG IMPORTATION
Article 2
Drugs that can be imported through special channel are:
- a. Drugs for clinical test purpose.
- b. Drugs in the framework of donation.
- c. Drugs for special therapeutic purpose.
Article 3
Importation of Drugs for clinical test as contemplated in Article 2 must comply with Decision of the National Agency of Drug and Food Control No. 02002/SK/KBPOM of 2001 on Clinical Test Procedure.
Article 4
(1) Drug Importation in the framework of donation as contemplated in Article 2 must comply with Guidelines of Donation Drugs of the National Agency of Drug and Food Control.
(2) Donation as meant in paragraph (1) is only for limited usage.
CHAPTER Ill
DRUGS FOR SPECIAL THERAPEUTIC PURPOSE
Article 5
(1) Drugs for special therapeutic purpose as contemplated in Article 2 are drugs that are needed by patients based on physician scientific justification in limited quantity.
(2) Physician scientific justification as meant in paragraph (1) must consider the following criteria:
- a. Drugs to overcome diseases that is life threatening or serious; or
- b. The available drugs are unable to overcome or control adequately the patients condition; or
- c. Drugs are unavailable because the production/supply of the same drugs that have distribution licence is stopped.
Article 6
Drugs for special therapeutic purpose as contemplated in Article 5 must be of types of drugs whose profile of effectiveness, safety and quality have been known.
CHAPTER IV
REQUIREMENTS OF IMPORTATION OF DRUGS FOR SPECIAL THERAPEUTIC PURPOSE
Article 7
Importation of drugs for special therapeutic purpose shall be conducted based on request of responsible doctor.
Article 8
(1) Request for Importation of drugs for special therapeutic purpose must be furnished with:
- a. Justification of responsible doctor for drugs that are needed by the patient using example Form OK-1.
- b. Adequate information of drug effectiveness and safety that can support the safety aspect of drug usage.
- c. Information of drug quality that includes analysis certificate of drug batch and summary protocol of special production batch for biological products or vaccines that will be imported.
- d. Information of drug quantity required.
(2) Information of drug quality as meant in paragraph (1) letter c is exempted for individual patients that are supported by consideration of the responsible doctor.
Article 9
Information of drug quantity required as meant in Article 8 letter d shall be in conformity with the quantity of drug needed for curing of the patient and not exceeding 12 (twelve) months of normal consumption.
CHAPTER V
IMPORTATION LICENCE OF DRUGS FOR SPECIAL THERAPEUTIC PURPOSE
Article 10
(1) Application for Importation Licence of drugs for special therapeutic purpose can be submitted by the importer (pharmaceutical industry or pharmaceutical wholesaler) on request of the responsible doctor or the National Drug Referral Centre (Pusat Rujukan Drugs Nasional).
(2) Application for importation of drugs for special therapeutic purpose shall be submitted to the Agency Head by using example Form OK-2 that is furnished by Form OK-1.
(3) National Agency of Drug and Food Control assess the application for licence of importation by paying attention to the risk benefit aspect.
(4) The Agency Head will issue the Importation Licence of drugs for special therapeutic purpose at the latest 10 (ten) working days as from the application documents complete.
(5) Approval of importation of drugs for special therapeutic purpose for a quantity that is requested shall be valid for 3-12 (three up to twelve) months after the approval date.
CHAPTER VI
REPORTING
Article 11
(1) Responsible doctor must monitor the use of drugs for special therapeutic purpose and report any serious Side Effects and alleged Side Effects to the Agency Head at the latest 7 (seven) days after the occurrence, using example Form OK-3.
(2) Reporting as meant in paragraph (1) must be accompanied with adequate explanation.
Article 12
Importer must report the distribution and usage including the rest of drug for special therapeutic purpose not later than 30 (thirty) days as of the end of medication by using example Form OK-4.
CHAPTER VII
REORDERING AND OBLIGATION TO REGISTER
Article 13
Reordering of importation of drugs for special therapeutic purpose for the same doctor and for the same drug can be conducted after submission of report of the previous drug usage.
Article 14
The rest of drug for special therapeutic purpose as meant in Article 12, if will be used further, must submit reordering in accordance with the prevailing provisions.
Article 15
Within a certain period and when the request reaches to the quantity that is required by the patient, registration of relevant drug must be submitted.
CHAPTER VIII
PROHIBITION TO ADVERTISE THE DRUGS FOR SPECIAL THERAPEUTIC PURPOSE
Article 16
Drugs for special therapeutic purpose are prohibited to be advertised or claimed for its supply for public sale both purposely and not.
CHAPTER IX
INSPECTION
Article 17
Inspection shall be conducted by the National Agency of Drug and Food Control and its personnel I regions to the distribution and usage of drugs for special therapeutic purpose.
CHAPTER X
SANCTIONS
Article 18
Anyone who purposely circulates any drugs for special therapeutic purpose without observing the prevailing provisions shall be subjected sanctions based on the prevailing law provisions.
CHAPTER XI
CLOSING PROVISION
Article 19
This Decision comes to effect as of the stipulation date.
Stipulated in: JAKARTA
On: April 2, 2002
The Head of National Agency of Drug and Food Control,
Sgd.
H. SAMPURNO
NIP. 140087747