The Requirements and Steps to Grab Distribution License in Indonesia

Every country has a responsibility to protect its society from any threat. However, unhealthy food and drug are also one of the threats as they could put the people in danger. Therefore, the government should guarantee that all products sold in the market are safe to eat and to use by its society. They must be free from any substances that are harmful to public’s health. 

United States has what is called by FDA (Food and Drug Administration) whose function is assuring that all food, biological products, and medical devices intended for human use are safe, sanitary, effective, and properly labeled. Almost similar with FDA in the US, Indonesia also has BPOM as a national agency of food and drug control. This non-ministry agency is firstly formed by the government of Indonesia in 2000 through the Presidential Regulation No.166/ 2000, amended to Presidential Regulation No 103/2002. Until now, BPOM responsible for supervising all products, both local and imported, before they can enter Indonesia market. The newest regulation about BPOM is written in Presidential Regulation No.80/2017. 

To grab distribution license over food and drug, you must fulfill some safety requirements. The requirements for local producer and foreign producer are different. The imported products, however, need more requirements as they are related to the export-import activity. Those requirements are explained in Regulation of the Head of the Agency of Drug and Food Control Indonesia Number 27/2013.

The first step to obtaining the distribution license is registering the product via online at www.pom.go.id. There, you could also download the guideline that you have to follow. There are some documents to prepare before you register. Make sure that you have all of these documents: 

1. Registration form
2. Audit results on storage facilities
3. Health certificate from the original company 
4. API (Imported Identification Number) and APIU (General Import Identification Number) 
5. Trade Business License
6. Taxpayer Registration Number (NPWP)
7. HS Code of Product 

The online registration must be done to get SKI (Surat Keterangan Import) or Import Certificate. There are some different additional requirements for registering drug, food, and cosmetics. The SKI for vaccines would require release and protocol certificate from the exporting country and the producer. 
If you are applying SKI for cosmetics, health supplements, traditional medicines and quasi-drugs, you must ensure that the name of the product written in the invoice is similar with that on the distribution license. But, you do not need to do this if you could submit an affidavit.

For food SKI, you need to provide an approved label, an affidavit, and a recommendation later from the agricultural ministry if your product is categorized as animal-based processed food. An additional certificate like a halal statement from MUI (Indonesian Council of Ulema) is also needed as the majority of Indonesian are Muslim.

After submitting all the documents, you need to wait for several working days until the electronic form of SKI is issued. The next step is the examination of your product in BPOM laboratory. This step could take until 4 months, or more depending on the product. If your product is safe, you could get your BPOM license and ML codes. But, if the product is categorized into lartas as it contains prohibited substances, you could get no license, or the BPOM will reexamine it again in the lab.

Reference: bimo prasetio