Legal Insights

Imported Drugs: Registration and Distribution License

In order to protect the public from the distribution of drugs that fail to meet Indonesia’s standard requirements on safety and quality, the government implements an evaluation mechanism for the approval of drug registration before they can be distributed in the territory of Indonesia. The evaluation system is administered by the Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan or BPOM).   

Stipulations on Imported Drugs and Distribution Licenses

Imported drugs pursuant to Article 1 no. 36 of BPOM Regulation No. 24/2017 are drugs manufactured by the Pharmaceutical Industry abroad in the form of finished products or bulk products in primary packaging to be distributed in Indonesia.  

Furthermore, Article 2 of BPOM Regulation No. 27/2022 on drugs that will be distributed within Indonesian territory states that the drug must have a distribution license and must also comply with the provisions of the existing laws and regulations.  

Requirements and criteria for obtaining a Distribution License  

In order to receive a distribution licence, the drugs shall fulfill the following criteria:ⁱ 

1. Convincing efficacy and adequate safety proven through nonclinical trials and clinical trials or other evidence in accordance with the status of scientific developments;  

2. Quality that meets the requirements in accordance with the established standards, including a production process that is in accordance with Good Manufacturing Practices (CPOB) and equipped with valid evidence; and  

3. Product information and labeling with objective and non-misleading information that ensures the appropriate, rational and safe use of the drugs.  

Parties that can apply for a Distribution License  

Registration of imported drugs may only be conducted by the domestic pharmaceutical industry that has obtained written approval from the foreign pharmaceutical company unless the registrant is an affiliate of the parent company.ⁱⁱ The foreign pharmaceutical industry as intended must have a pharmaceutical industry license and has fulfilled the CPOB requirements of the authorities of the local country. Please note that the distribution of imported drugs can only be done by the distribution license holder or his/her proxy.ⁱⁱⁱ 

New Registration Stages  

Pharmaceutical industry businesses must go through two stages in the new registration process, namely:iv  

1. Preregistration stage. The registrant shall submit a written application to the Head of BPOM, settle the payment, and complete the required preregistration documents. 

2. Registration stage. The registrant can submit a written application by filling out a form and attaching the necessary documents, namely: administration, quality, non-clinical, and clinical documents. 

Criteria for Imported Medicines that do not need a Distribution License  

Although imported drugs must have a distribution license before they are distributed in Indonesia, there are exceptions if the drugs are to be intended for certain purposes. These purposes are:v 

1. own/personal use;  

2. Research;  

3. product and/or science development; 

4. donation; 

5. samples for registration/registration of distribution licenses;  

6. clinical trials for registration requirements, product development, and/or science;  

7. government programs;  

8. urgent national interest;  

9. special use for health services that cannot be produced domestically; and  

10. Exhibition.  

The import of these drugs must still fulfil a number of requirements, specifically that they are not intended for sale and are imported in limited quantities in accordance to the needs and must be transported through a special access scheme.  

In addition, there are additional provisions for the exemption of distribution licenses for drugs and food as described above, namely:vi  

1. For research, product development, and exhibitions not intended for market tests;  

2. For donations, which is valid only for medicine, traditional medicine, health supplements, quasi medicine and processed food;  

3. Clinical trials for registration requirements, product development, and/or science, urgent national interests, and special uses for health services that cannot be produced domestically. These stipulations only apply to drugs, traditional medicines, health supplements, quasi drugs and processed foods with claims of reducing the risk of disease;  

4. For exhibitions, which only applies to traditional medicine, quasi medicine, health supplements, cosmetics, and/or processed food.  

Legal Consequences of Using Imported Medicines Without a Distribution License 

If the distribution of imported drugs is carried out without a distribution license or not in accordance with the provisions of drug imports for certain purposes (distribution permit exceptions), administrative sanctions are imposed in the form of:vii 

1. written warning;  

2. temporary suspension of entry and/or circulation activities;  

3. electronic closure of access to applications for border SKIs or post-border SKIs for the product concerned for a maximum of 1 year;  

4. withdrawal of drug and food products from circulation;  

5. destruction or re-export;  

6. suspension of distribution license; and/or  

7. revocation of distribution license.  

For more information, contact us at info@business-Indonesia.org