A drug store is a facility or business that has a license to store over-the-counter drugs and limited over-the-counter drugs for retail or direct sale to consumers. Provisions for the issuance of drug store permits are regulated in Minister of Health Regulation Number 14 of 2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Health Sector (“Permenkes 14/2021”). Based on Permenkes 14/2021, every drug store must first obtain a store permit from the Ministry of Health in order to carry out these activities.
For those of you who want to know how to take care of a drug store license in a risk-based OSS, we describe the steps below:
CHOOSE THE STANDARD CLASSIFICATION OF BUSINESS FIELD IN INDONESIA (“KBLI”) DRUG SHOP
For those of you who are just starting a business or don't understand the process of starting a business in Indonesia, you can read the following article as your brief guide:
Important Things You Need To Know Before Starting A Business In Indonesia
You can use KBLI 47722 Retail Trade on Pharmaceutical Goods and Drugs for Humans Not in Pharmacies or 47842 Retail Trading of Pharmacy on Street And Los Markets as your drugstore business field.
COMPLETE THE REQUIREMENTS
After you have your NIB and unverified Standard Certificate/Permit for drugstores, it's time for you to complete the necessary requirements, including:
1. Cooperation Agreement with Pharmaceutical Technical Personnel (“TTK”) in this case is a pharmacist who has a Registration Certificate (“STR”) and a Practice License (“SIP”)
2. Drug Store Organizational Structure
3. Standard Operating Procedures in Drug Stores
4. Drug Store Signboard
5. Pharmacist Practice Nameplate
6. Environmental Management Statement (SPPL)
7. Drug Store Building Plan
8. Duties and Responsibilities of Drug Store employees
THINGS THAT NEED ATTENTION
In addition to the document requirements, you must also meet the provisions stipulated in the Minister of Health Regulation 14/2021, especially regarding drug stores, including:
1. Drug Store Buildings must:
– is permanent
- safe and comfortable
– have safety protection
- well maintained and functioning condition
2. Drug Store Room Facilities:
- have a drug storage room according to regulations
- have a drug service room according to the provisions
– have a document storage space according to the provisions
3. Drug Store Infrastructure:
- have a source of clean water
- have a trash can according to the provisions
– have electrical installations that are easy to operate, observe, maintain, do not harm, and do not interfere with the environment, building parts, and other installations
– have an adequate lighting system
– has an air circulation installation
- have a fire prevention and suppression system
- have an adequate communication system
– has a toilet
SUBMIT APPLICATION
After the requirements are complete, you can apply for your drugstore license via OSS here. The officer will check the completeness of your requirements, if it is declared complete it will be scheduled for technical verification, the officer will check directly to your drug store location to ensure that your drug store is in accordance with the standards or not. After verification and your drugstore is declared complete, the officer will issue an official report to be forwarded to the OSS system manager for further processing. At the final stage, OSS will issue your verified Standard/Permit Certificate, and the Standard/Permit Certificate is valid for a maximum of 5 years.
Thus the article Managing Drug Store Permits in Risk-Based OSS, hopefully it can help you.
