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In Indonesia, medicines have to be registered in
accordance with Regulation of the Health Minister
No. 1010/MENKES/PER/XI/2008 (Reg. 1010 of 2008)
and its amendment, Regulation of the HealthMinister
No. 1120/MENKES/PER/XII/2008 (Reg. 1020 of
2008). Medicine is defined as finished medicine which
constitutes preparation or combination of substances
including biological product and contraceptive which
is used to influence or investigate a physiologic
system or pathologic condition within the frame of
diagnosis, prevention, cure, rehabilitation and health
improvement. According to Article 2 of Reg. 1020
of 2008, medicines which are to circulated in the
Indonesian territory shall undergo prior registration
to get a circulation permit. Imported medicine shall
be imported by domestic pharmaceutical industry
that has obtained written approval from overseas
pharmaceutical industry. This written approval must
include a transfer of technology provided that within
a period of five years at the latest that the medicine
must have been produced domestically (Article 10 of
Reg. 1020 of 2008).
LABELING
Labeling allows consumers to obtain information on
products they buy and consume. Thus, labeling also
provides further consumer protection.
a. Content and Language Requirement
Regulation No. 73/M-DAG/PER/9/2015 on the
Obligation to Affix Indonesian-language Label (Reg.
73 of 2015) governs the obligation of companies
that import, sell and distribute goods in Indonesia
to affix a label that contains specific information
in Bahasa Indonesia. The following information is
required:
• identity of the business (name and address of
the producer, importer, and reseller);
• safety, security, and health information;
• usage Information; and
• relevant hazard symbols and warning
information (if applicable).
These rules apply to the following goods:
• electronic household goods;
• telecommunications
and
information-
technology equipment;
• building material;
• motor-vehicle spare parts;
• textiles; and
• several other goods (Appendix I to V of Reg. 73
of 2015).
Companies which do not comply with this
regulation may face administrative sanctions, such
as revocation of import identification number,
revocation of business trade license, and revocation
of other business-related licenses.
b. Food
Government Regulation No. 69 of 1999 concerning
Food Labeling and Advertisement (Reg. 69
of 1999) regulates labeling for food, which is
defined as everything originating from biological
source and water, whether processed or not,
which is designated as a food or drink for human
consumption, including food additive, food raw
material and/or the making of food and beverages.
In general, produced or imported packed food to
be traded in Indonesia is required to have a stick
up label on and/or in the food packaging. The label
shall contain any information on the food, at least
the label shall contain the following information:
• name of product;
• list of ingredients;
• net weight or net content;
• name and address of any party who produces
or imports the food into Indonesia;
• date, month, and year of minimum durability.
Furthermore, Reg. 69 of 1999 requests that the
main information, name of product, net weight
or net content and name and address of any party
who produces or imports the food into Indonesia
shall be presented in an orderly and clear manner,
which is easy to read. Furthermore, any statement
on the label shall be in Indonesian language, Arabic
numbers and Latin letters.
