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REGULATION OF THE INDONESIAN FOOD AND DRUG AUTHORITY NUMBER 5 OF 2026 CONCERNING SUPERVISION OF THE MANAGEMENT OF MEDICINES AND DRUG SUBSTANCES IN PHARMACEUTICAL SERVICE FACILITIES AND OTHER FACILITIES

BY THE GRACE OF THE ONE ALMIGHTY GOD

HEAD OF THE INDONESIAN FOOD AND DRUG AUTHORITY,

Considering :

that the public needs to be protected from the risks of medicines and drug substances that do not meet safety, efficacy, and quality requirements, as well as the risks of irregularities in the management of medicines and drug substances that may endanger public health;
that the provisions regarding the management of medicines, drug substances, narcotics, psychotropics, and pharmaceutical precursors as regulated in Regulation of the Indonesian Food and Drug Authority Number 24 of 2021 concerning Supervision of the Management of Medicines, Drug Substances, Narcotics, Psychotropics, and Pharmaceutical Precursors in Pharmaceutical Service Facilities are no longer in accordance with legal developments, so they need to be replaced;
that based on the provisions of Article 3 paragraph (1) letter d of Presidential Regulation Number 80 of 2017 concerning the Indonesian Food and Drug Authority, the Indonesian Food and Drug Authority has the function of carrying out supervision before circulation and supervision during circulation;
that based on the considerations as referred to in letter a, letter b, and letter c and to implement the provisions of Article 417 paragraph (4) of Government Regulation Number 28 of 2024 concerning Implementing Regulations of Law Number 17 of 2023 concerning Health, it is necessary to establish a Regulation of the Indonesian Food and Drug Authority concerning Supervision of the Management of Medicines and Drug Substances in Pharmaceutical Service Facilities and Other Facilities;

In view of :

Government Regulation Number 28 of 2024 concerning Implementing Regulations of Law Number 17 of 2023 concerning Health (State Gazette of the Republic of Indonesia of 2024 Number 135, Supplement to the State Gazette of the Republic of Indonesia Number 6952);
Presidential Regulation Number 80 of 2017 concerning the Indonesian Food and Drug Authority (State Gazette of the Republic of Indonesia of 2017 Number 180);
Regulation of the Indonesian Food and Drug Authority Number 21 of 2020 concerning Organization and Work Procedures of the Indonesian Food and Drug Authority (State Gazette of the Republic of Indonesia of 2020 Number 1002) as amended by Regulation of the Indonesian Food and Drug Authority Number 13 of 2022 concerning Amendment to Regulation of the Indonesian Food and Drug Authority Number 21 of 2020 concerning Organization and Work Procedures of the Indonesian Food and Drug Authority (State Gazette of the Republic of Indonesia of 2022 Number 629);
Regulation of the National Agency of Drug and Food Control Number 19 of 2023 concerning the Organization and Work Procedure of Technical Implementation Units at the National Agency of Drug and Food Control (State Gazette of the Republic of Indonesia of 2023 Number 611) as amended several times, most recently by Regulation of the National Agency of Drug and Food Control Number 1 of 2026 concerning the Second Amendment to Regulation of the National Agency of Drug and Food Control Number 19 of 2023 concerning the Organization and Work Procedure of Technical Implementation Units at the National Agency of Drug and Food Control (State Gazette of the Republic of Indonesia of 2026 Number 61);

HAS DECIDED:

To stipulate :

REGULATION OF THE NATIONAL AGENCY OF DRUG AND FOOD CONTROL CONCERNING SUPERVISION OF THE MANAGEMENT OF MEDICINES AND MEDICINAL INGREDIENTS IN PHARMACEUTICAL SERVICE FACILITIES AND OTHER FACILITIES.

CHAPTER I
GENERAL PROVISIONS

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