DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL
No. HK.00.05.23.3874

CONCERNING
IMPLEMENTATION OF REPORTING OF INFORMATION ON PHARMACEUTICAL INDUSTRY

THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL,

Considering:

• a. that in order to support development of pharmaceutical industries, clear and adequate information of pharmaceutical industrial activity is required;
• b. that data of information on pharmaceutical industrial activity must be gathered and complete as well as continuous;
• c. that in relation to the foregoing, it is necessary to stipulate an Implementation of Reporting of Information on Pharmaceutical Industry with a Decision of the Head of National Agency of Drug and Food Control.

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. 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. 46/2002;
• 4. Presidential Decree No. 110/2001 on Organisation Unit and Duties of Echelon I in Non Departmental Government Institutions, as amended by Presidential Decree No. 48/2002;
• 5. Decree of the Minister of Health No. 245/ Menkes/SK/V/1990 on Provisions and Procedures of Implementation on Pharmaceutical Industrial Licence Granting;
• 6. Decision of the Head of National Agency of Drug and Food Control No. 02001/SK/KBPOM of 2001 on Organisation and Work Procedure of National Agency of Drug and Food Control.

Bearing in mind:

Joint Decree of the Minister of Health of the Republic of Indonesia No. 264A/Menkes/SKB/VII/2003 and the Minister for State Apparatus of the Republic of Indonesia No. 02/SKB/M.PAN/7/2003 on Duties, Functions and Authorities in the Field of Drug and Food Control.

DECIDES:

To stipulate:

First:

DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL ON IMPLEMENTATION OF REPORTING OF INFORMATION ON PHARMACEUTICAL INDUSTRY

Second:

Pharmaceutical Industries that have obtained Pharmaceutical Industrial Business License are obliged to submit information periodically concerning their activities and production results.

Third:

Information as contemplated in Secondly dictum shall be submitted in the form of:

• a. Data of pharmaceutical industrial company (Form POM-9);
• b. Annual production and marketing data (Form POM-9f);
• c. Data of finished drug production realization (Form POM-9a);
• d. Data of pharmaceutical raw materials production realization (Form POM-9b)
• e. Data of raw /auxiliary materials usage realization (Form POM-9c);
• f. Data of finished drug import realization (Form POM-9d);
• g. Data of finished drug or pharmaceutical raw materials export realization (Form POM-9c, specially for the pharmaceutical industries that export);

Fourth:

• - Report as contemplated in Thirdly dictum shall be submitted periodically on the following provisions:
• - Reports referred to items a and b shall be submitted once every year (if there is a change in items reported);
• - Reports referred to items c, d and e shall be submitted once every 3 (three) months;

Fifth:

Report of pharmaceutical industrial data and other data as contemplated in Thirdly dictum shall be submitted to the Head of National Agency of Drug and Food Control with copy to the Head of local Headquarters/Centre of Drug and Food Control (Balai Besar/Balai Pengawasan Obat dan Makanan) ot later than 1 (one) month as of the relevant reporting period, in exception for export and import realization data report not later than on the 15th day of next month.

Sixth:

Procedures of reporting shal lbe implemented by using forms as exemplified in the attachment to this Decision.

Seventh:

Upon stipulated on this Decision, the Decision of the Director General of DFC No. PO.02.02.2.02537 of 1997 on Implementation of Reporting of Information on Pharmaceutical Industry is declared as null and void.

Eighth:

This Decision comes to effect as of the stipulation date and in the event any shortage or error is found, it will be amended and revised accordingly.

Stipulated in: JAKARTA
On: October 21, 2003
THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL RI,
Sgd.
H. SAMPURNO