Addition of Drug Registration Requirements to Strengthen Monitoring Before Distribution

Corporate Secretary Service Indonesia – The government continues to strengthen drug supervision before and after circulation. The Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan / BPOM) has even added registration requirements for drug distribution licenses to maintain the quality and safety of drugs consumed by citizens. Strengthening the drugs/medicine supervision system before and after circulation in the market aims to improve quality control and quality.

In Indonesia, drug registration is regulated in the Food and Drug Supervisory Agency Regulation Number 13 of 2021 (“BPOM Regulation 13/2021”) on the Third Amendment to the Regulation of the Head of the Food and Drug Supervisory Agency Number 24 of 2017 on Criteria and Procedures for Drug Registration and the Regulation of the Minister of Health of the Republic of Indonesia Number 1010/MENKES/PER/XI/2008 on Drug Registration.

In Article 1, paragraph (1) of BPOM Regulation 13/2021, drug registration is a procedure for registering and evaluating drugs to obtain approval. Registration is carried out to obtain a Distribution License Number (Nomor Izin Edar or NIE) or Drug Registration Number so that the drugs traded have been registered with BPOM and so that with supervision, the drug can be guaranteed to be safe, efficacious, and of high quality.

A distribution permit is a form of approval for drug registration to be circulated in the territory of Indonesia. Meanwhile, Permenkes Number 1010/MENKES/PER/XI/2008 states that to protect the public from the circulation of drugs that do not meet the requirements, safety, quality, and benefits, it is necessary to conduct an assessment through a drug registration mechanism. Referring to BPOM Regulation 13/2021, there are several types of drug registration, including:

New Registration

This is a registration for drugs that still need to receive a distribution license in Indonesia.

Variation Registration

It is the registration of changes to the administrative aspects, efficacy, safety, quality, and/or product information and labelling of drugs licensed in Indonesia. Variation registration can be divided into:

1. Major variation registration, which is the registration of variations that significantly affect the efficacy, safety, and/or quality of a medicine;
2. Minor variation registration, which is the registration of variations that do not fall into the category of major variation registration or notification variation registration;
3. Notification variation registration, which is the registration of variations that have minimal or no effect on the efficacy, safety, and/or quality of the medicine, does not change the distribution permit information.

Read Also: Have a Cosmetics Business? This is the Permit Requirement!

Re-registration

This is a registration that extends the validity period of the distribution license. However, some drugs/medicine are exempted from the registration obligation to obtain a distribution permit. This is summarized in Article 2 paragraph (4) of Permenkes 1010/2008, for the following Drugs/Medicine:

1. Special use drugs at the request of a doctor
2. Donation medicine
3. Drugs for clinical trials
4. Sample medicine for registration

The drugs listed above can be imported into Indonesian territory through a unique channel mechanism whose provisions are determined by the minister.

To obtain a distribution license, drugs must meet the following criteria:

1. Convincing efficacy and adequate safety proven through animal experiments and clinical trials or other evidence in accordance with the status of scientific development concerned;
2. Qualified quality assessed by the production process in accordance with Good Manufacturing Practices (GMP), specifications and testing methods for all materials used and finished products with valid evidence;
3. Marking contains complete and objective information that can ensure the proper, rational, and safe use of drugs;
4. By the real needs of the community;
5. Other criteria are specifically for psychotropic drugs that must have superiority in benefits and safety compared to standard drugs and drugs that have been approved to circulate in Indonesia for the claimed indications;
6. Especially for contraceptives for national programs and other program drugs that will be determined later, clinical trials must be carried out in Indonesia.

To obtain a distribution license in the territory of Indonesia, it is necessary to register, which can be done online through the website of the Directorate of Drug Registration of the Food and Drug Monitoring Agency (BPOM). There are provisions for applicants in the implementation of drug registration, including the following:

1. Application for drug registration services must be made by the applicant;
2. The applicant is the head of a company/industry that has a license in accordance with the provisions of laws and regulations;
3. The head of the company/industry may authorize employees within the company/industry to apply for drug registration services within the Directorate of Drug Registration;
4. Employees who are authorized by the head of the company must have the knowledge and competence in accordance with the proposed drug registration service;
5. Company/industry leaders are prohibited from using service bureaus or brokers to submit applications for drug registration services within the Directorate of Drug Registration.

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