THE REGULATION OF THE MINISTER OF HEALTH ON THE BUSINESS LICENCE FOR TRADITIONAL DRUG INDUSTRIES AND THE REGISTRATION OF TRADITIONAL DRUGS.
Hereinafter referred to as:
(1) The business licence of the Minister shall be required for the establishment of traditional drug industries.
(2) No licensing shall be required for the jamu mixture business and the jamu vendor business.
(1) Traditional drugs which are produced, distributed in the Indonesian territory as well as exported shall first be registered for the approval of the Minister.
(2) Exempted from the provision in paragraph (1) shall be traditional drugs produced by:
(3) Traditional drugs produced by small scale traditional drug industries other than those referred to in paragraph (2) point a shall be subjected to the provision in paragraph (1).
(1) Traditional drugs which are exempted from the obligation of registration as meant in Article 3 paragraph (2) shall only use materials of traditional drugs as contained in Attachment 1 to this regulation.
(2) The jamu mixture business and the jamu vendor business shall not be allowed to use materials of traditional drugs other than those contained in Attachment 1 to this regulation.
(3) The list as meant in paragraph (1) shall be subject to review and re-stipulation by the Director General.
(4) Traditional drugs which are exempted from the obligation of registration as meant in Article 3 paragraph (2) shall have their uses determined by the Director General.
(1) The Minister shall delegate the authority to grant the business licence for traditional drug industries, the business licence for small scale traditional drug industries and the approval of traditional drug registration, to the Director General.
(2) The Director General shall delegate the authority to grant the business licence for small scale traditional drug industries to the Head of the Regional Office.
(1) Traditional drug industries shall be obligated to fulfil the following requirements:
(2) Small scale traditional drug industries shall be obligated to fulfil the following requirements:
Traditional drug industries shall be established in pollution-free areas and shall not cause pollution to the environment.
(1) Traditional drug industries shall regularly employ at least one Indonesian pharmacist as the technical manager.
(2) The exception to the provision in paragraph (1) shall be small scale traditional drug industries which only produce traditional drugs as meant in Article 3 paragraph (2) and Article 4 paragraph (1).
(1) Traditional drug industries and small scale traditional drug industries shall follow guidelines on the proper method of traditional drug making (CPOTB).
(2) The fulfilment of the requirement as meant in paragraph (1) shall be declared by authorised officials through spot checks.
(3) In certain cases the fulfilment of the requirement as meant in paragraph (2) shall be declared with CPOTB certificates issued by authorised local officials.
(4) The guidelines as meant in paragraph (1) shall be stipulated by the minister.
(1) Principle approval shall be required for obtaining the business licence for traditional drug industries and small scale traditional drug industries.
(2) Principle approval is given to applicants to enable them to make direct preparations and undertake construction, procurement, installation of equipment and other necessary efforts at the locations already approved.
(3) The business licence shall be granted to applicants already fulfilling the requirements as stipulated in Article 6, Article 7, Article 8 and Article 9.
(4) Traditional drug industries and small scale traditional drug industries which expand their capacities or forms of preparations shall not be required to obtain the expansion licence.
The business licence for traditional drug industries or small scale traditional drug industries shall be valid as long as the traditional drug industries or the small scale traditional. drug industries concerned are still engaged in production, and are not involved in violations as meant in Article 20.
(1) Applications for principle approval for the establishment of traditional drug industries shall be submitted to the Director General by using the form according to the model TRAD-1.
(2) Applications for principle approval for the establishment of small scale traditional drug industries shall be submitted to the Head of the Regional Office with copies to the Director General, by using the form according to model TRAD-2.
(3) Within 12 (twelve) working days after the receipt of complete applications, the Director' General shall issue principle approval by using the form according to model TRAD-3, or reject the applications by using the form according to model TRAD-4.
(4) Within 12 (twelve) working days after the receipt of complete applications, the Head of the Regional Office shall issue principle approval by using the form according to model TRAD-5 or to reject the applications by using the form according to model TRAD-6, with copies addressed to the Director General.
(1) Principle approval shall be valid for a maximum of 3 (three) years.
(2) In certain cases connected with project construction, applicants can submit requests for the extension of principle approval for traditional drug industries or small scale traditional drug industries containing the reasons for such extension, by using the form according to model TRADE-7 or model-TRAD-8.
(3) In response to the applications as meant in paragraph (2) the Director General or the Head of the Regional Office can extend the validity period of principle approval for traditional drug industries or small scale traditional drug industries for a maximum of 1 (one) year by using the form according to model TRAD-9 or TRAD-10.
(4) After obtaining principle approval, applicants shall submit information on the progress of project development annually to the Director General as far as traditional drug industries are concerned by using the form according to model TRAD-11.
(5) Principle approval shall be automatically cancelled if within 3 (three) years applicants fail to carry out physical construction activities, unless the principle approval is extended as meant in paragraph (3).
(1) Applications for the business, licence for traditional drug industries shall be submitted by the Relevant applicants to the Director General with copies addressed to the Head of the Regional Office by using the form according to model TRAD-12.
(2) Applications for the business licence for small scale traditional drug industries shall be submitted by the relevant applicants to the Head of the Regional Office by using the form according to model TRAD-13.
(3) Not later than 7 (seven) working days after the receipt of copies of applications for traditional drug industries or applications for small scale traditional drug industries, the Head of the Regional Office or authorised officials shall assign the Head of the Centre to conduct spot inspection of the preparedness of traditional drug industries or small scale traditional drug industries to realise production, by using form according to model TRAD-14.
(4) Not later than 14 (fourteen) working days after receiving the assignment from the Head of the Regional Office, the Head of the Centre shall report results of the inspection as meant in paragraph (3) to the Head of the Regional Office by using the form according to model TRAD-15.
(5) Not later than 7 (seven) working days after the receipt of results of inspection of the preparedness of traditional drug industries from the Head of the Centre, the Head of the Regional Office shall report the results to the Director General by using the form according to model TRAD-16.
(6) In the case of the absence of inspection as meant in paragraph (4), the relevant applicants for traditional drug industries can make out statements on the preparedness of production to the Director General with copies addressed to the Head of the local Regional Office and the relevant applicants for small scale traditional drug industries can make out statements on preparedness of production of the Head the local Regional Office by using the form according to model TRAD-17 or TRAD-18.
(7) Within 14 (fourteen) working days after the receipt of reports from the Head of the Regional Office as meant in paragraph (5) or statements as meant in paragraph (6), the Director General shall issue, postpone, or reject applications for, the business licence for traditional drug industries by using the form according to model TRAD-19, TRAD-20, or TRAD-21.
(8) Within 14 (fourteen) working days after the receipt of inspection as meant in paragraph (4) or statements as meant in paragraph (6), the Head of the Regional Office shall issue, postpone, or reject applications for the business licence for small scale traditional drug industries by using the form according to model TRAD-22, TRAD-23, or TRAD-24.
(1) Small scale traditional drug industries which increase their production capacities so that they have each a total asset exceeding Rp 600,000,000 (six hundred million rupiahs) shall be obligated to submit applications for the business licence for traditional drug industries by using the form according to model TRAD-12.
(2) The procedure for licensing as meant in paragraph (1) shall follow the provisions in Article 14.
Applications for the business licence for traditional drug-industries and small scale traditional drug industries shall be rejected if the locations of industries are not in line with those contained in principle approval.
The granting of the business licence shall be postponed if the requirements stipulated in Article 6, Article 8 and Article 9 are not fulfilled yet.
In the case of postponement of the granting of the business licence as meant in Article 16, the traditional drug industries or the small scale traditional drug industries concerned shall have the opportunity to meet the requirements not yet fulfilled within a maximum of 6 (six) months starting from the receipt of letters of postponement as meant in Article 14 paragraphs (7) and (8).
Traditional drug industries or small scale traditional drug industries shall submit information periodically concerning their operations:
(1) The information of traditional drug industries as meant in Article 18 shall be submitted to the Director General with copies addressed to the Head of the Regional Office.
(2) The information of small scale traditional drug industries as meant in Article 18 shall be submitted to the Head of the Regional Office with copies addressed to the Director General.
The business licence for traditional drug industries or small scale traditional drug industries shall be revoked in the following cases:
(1) In the case of traditional drug industries or small scale traditional drug industries committing violations as meant in Article 20, they shall be warned in writing 3 (three) times successively at 2 (two) months' intervals by using the form according to model TRAD-27 or TRAD-28.
(2) If 2 (two) months after the issuance of the third meeting the industries concerned fail to make improvements as required in previous warnings, their business licence shall be frozen by using the form according to model TRAD-29 or TRAD-30.
(3) If 6 (six) months after the issuance of licence freezing notifications the industries as meant in paragraph (2) fail to make improvements as required in the notifications, their business licence shall be revoked using the form according to model TRAD-29-or TRAD-30.
(4) The freezing of the business licence for traditional drug industries or small scale traditional drug industries as meant in paragraph (2) can be lifted if the traditional drug industries or small scale traditional drug industries concerned have made improvements as required in the licence freezing notifications, by using the form according to model TRAD-31 or TRAD-32.
(1) Traditional drug industries or small scale traditional drug industries which change the names of companies or production technical managers shall notify the Director General or the Head of the Regional Office in writing by using the form according to model TRAD-33 or TRAD-34.
(2) Not later than 14 (fourteen) working days after the receipt of complete notifications as meant in paragraph (1), the Director General of the Head of the Regional Office shall issue letters of approval or rejection by using the form according model TRAD-35 or TRAD-36.
(3) Traditional drug industries or small scale traditional drug industries which transfer or move plants to other locations shall be obligated to submit applications for renewal of the business licence to the Director General or the Head of the Regional Office by using the form according to model TRAD-12 or TRAD-13.
(4) The renewal of the business licence as meant in paragraph (3) shall be realised according to Article 14.
For the registration of traditional drugs as meant in Article 3, the traditional drugs concerned shall fulfil the following requirements:
The registration of traditional drugs as meant in Article 3 shall be indefinitely valid.
(1) The registration of traditional drugs as meant in Article 3 shall be granted to traditional drug industries or small scale traditional drug industries which have obtained the business licence.
(2) For the registration of traditional drugs as meant in Article 3 the industries referred to in paragraph (1) shall submit applications to the Director General by using the form according to model TRAD-37.
(1) Not later than 6 (six) months after the receipt of applications, the Director General shall issue:
(2) Applicants shall complete data as meant in paragraph (1) point c., not later than 3 (three) months starting from the date of the request for data completion, by using the form according to model TRAD-41.
(3) In the case of failure to complete data within the period as meant in paragraph (2) the Director General shall reject the relevant applications for registration by using the form according to model TRAD-42.
(4) Not later than 3 (three) months after the receipt of complete data as meant in paragraph (2), the Director General shall issue letters of approval or rejection as stipulated in paragraph (1).
The registration of traditional drugs shall be exempted from registration fees.
(1) Traditional drugs whose applications for. registration have been approved shall be granted registration numbers.
(2) The registration numbers as meant in paragraph (1) shall be printed on containers or labels, packages S brochures.
Traditional drug industries and small scale traditional drug industries shall submit information every year on the traditional drugs already approved for registration and still being produced, to the Director General by using the form according to the model TRAD-43.
(1) The registration of traditional drugs as meant in Article 3 shall be cancelled if any of the following takes place:
(2) The cancellation of approval for registration shall use the form according to model TRAD-44.
Containers of traditional drugs shall be made of materials which do not affect quality and can sufficiently protect their contents.
(1) Letters of approval for drug registration as meant in Article 3 shall stipulate the label markings approved.
(2) The packages, containers, tags and brochures of traditional drugs shall bear label markings as meant in paragraph (1).
(1) The packages, containers or tags/labels and brochures of Indonesian traditional drugs shall bear the word "JAMU" in a circle on the upper left part.
(2) The word "JAMU" as meant in paragraph (1) shall be clear and legible, of the size of at least 5 (five) millimetres in height and . (half) a millimetre in thickness, printed in black on a white base or other colours of good contrast.
(3) The packages, containers or tags/labels and brochures of Indonesian traditional drugs shall bear a leaf symbol in a circle on the upper left part.
(4) The leaf symbol as meant in paragraph (3) shall be clear, of the size of at least 10 (ten) millimetres in height, printed in black on a white base or other colours of good contrast, according to the form and shape described in Attachment 46 to this regulation.
The label markings on packages, containers, tags and or brochures shall bear the following information:
The label markings as meant in Article 34 shall not be easily disfigured by water, friction, or the effect of sun light.
(1) The label markings as meant in Article 34 shall be in the Indonesian language with the roman alphabet.
(2) For exports, besides the provision in paragraph (1), label markings can also be added with other languages and alphabets, on the conditions that the substance and meaning shall be the same as that of Indonesian markings.
The names of ingredients in the compositions as meant-in Article 34 point b. shall be in Latin according to the Pharmacopoeia of Indonesia, the Extra Pharmacopoeia of Indonesia or other books as stipulated by the Minister.
(1) The Centre for Food and Drug Inspection shall conduct spot checks of traditional drug industries and small scale traditional drug industries in order to provide guidance within the framework of quality maintenance, pursuant to the laws in force.
(2) Traditional drug industries and small scale traditional drug industries shall be open to inspection of their process of production and distribution of products by officials of the Ministry of Health appoint ed on the basis of letters of assignment of the Director General or the Head of the Regional Office.
(1) Traditional drug industries or small scale traditional drug industries shall be prohibited to produce:
(2) Small scale traditional drug industries shall be prohibited to produce licensed traditional drugs.
Traditional drugs shall not contain other materials which are excluded from the compositions as reported in applications for registration.
The following promotion of traditional drugs shall be prohibited:
(1) All provisions concerning the licensing and registration of traditional drugs already issued before the stipulation of this regulation shall remain valid as long as they are not contradictory to this regulation until further stipulation of new provisions.
(2) Traditional drugs already registered before the enforcement of this regulation shall be reregistered according to the provisions in this regulation after the expiration of their registration numbers.
(3) The production licence for jamu factories and jamu companies issued before the enforcement of this regulation shall remain valid until expiration.
Technical implementation which is not yet sufficiently regulated in this regulation shall be further stipulated by the Director General.
This regulation shall come into force as from the date of stipulation.
For public cognizance, this regulation shall be announced by publishing it in the State Gazette of the Republic of Indonesia.
Stipulated in Jakarta
On May 28, 1990
THE MINISTER OF HEALTH
sgd.
DR. ADHYATMA, MPH