BPOM LICENSE
Maxx's Group

bPOM

 

So many company owners have difficulty managing BPOM permits for snacks and medicines that they sell. This is due to the assumption that obtaining BPOM permits is very difficult and must pass various requirements to obtain certification from a special regulatory body.

The Agency for Drug and Food Control, abbreviated as BPOM, means a body or institution that has the authority to oversee the distribution of medicines and food products in Indonesia. The Food and Drug Monitoring System (SISPOM) that is implemented is effective and efficient enough to detect, monitor and prevent products on the market. What for?

Obviously, in order to protect the safety, health and security of consumers who buy these products. Therefore, Maxx’s Group Internasional is here to serve you in managing the process of making permits for BPOM with best deals and prices, also excellent services.

BPOM LICENSE

# 1 What Is BPOM?

The Agency for Drug and Food Control, abbreviated as BPOM, means a body or institution that has the authority to oversee the distribution of medicines and food products in Indonesia.

The Food and Drug Monitoring System (SISPOM) that is implemented is effective and efficient enough to detect, monitor and prevent products on the market.

What for? Obviously, in order to protect the safety, health and security of consumers who buy these products.

Following are the basic principles of SISPOM (source: BPOM website)

Fast, precise, accurate and professional security measures.

Actions are carried out based on the level of risk and based on scientific evidence.

The scope of supervision is comprehensive, covering the entire process cycle.

National / cross-provincial scale with international networks.

Authority that supports the rule of law.

Has a cohesive and strong national laboratory network that collaborates with global networks.

Have a safety information system and product quality network.

Also Read:

Credit Cards as Business Development Tips

Why Must Have a BPOM Circular?

It is very important to have a marketing authorization from BPOM for a medicinal, food and cosmetic product. One of them is because many people still doubt the products without BPOM’s permission.

Therefore, for the sake of running a business, BPOM certification is important to obtain so that all products that you sell are recognized as safe for consumers.

Simply put, with BPOM’s permission, you will also get many benefits, namely:

Legality that will guarantee product quality.

As a security guarantee for a product.

The stability of prices of products licensed by BPOM.

Product image will increase compared to competing products that have not been licensed by BPOM.

Easy entry into broader markets.

III. BPOM Licensing Function

There are several functions you need to know from BPOM licensing for a consumer product, including:

Regulations, regulations, standardization.

Industrial licenses and certifications in the pharmaceutical field based on good SOP.

Evaluate the product before it is allowed to circulate.

Post Marketing Vigilance, including laboratory sampling and testing, inspection of production and distribution facilities, as well as investigation and law enforcement.

Pre-audit & post-audit of advertising and product promotion.

Research on the implementation of drug and food control policies.

Communication, information and public education, including public warnings.

# 2 BPOM Licensing Registration Process BPOM Licensing Registration

Process

There are differences in BPOM licensing requirements between domestic and foreign products. In addition, there are two types of food assessment classifications, namely general assessment and ODS (One Day Service) assessment.

The general assessment is for all high-risk products and new products that have never gotten a registration number. ODS assessment is for all low-risk products and similar products that have received a registration number.

  1. Domestic Products
  2. Domestic Product Registration Requirements

The minimum requirements you must meet to register your domestic product with BPOM, namely:

Photocopy of Industrial License from the Ministry of Industry and Trade (Disperindag) or the Investment Coordinating Board (BKPM).

The results of the original laboratory analysis (valid 6 months after the test date), relating to nutritional products, substances claimed according to the label, chemical tests, microbiological contamination, and metal contamination.

Design the label in accordance with what will be circulated and product samples.

Complete registration form.

Specifically for ODS (One Day Service), a letter of approval for similar products and labels that have got a registration number must be attached.

Forms that have been filled out, then reproduced 4 copies each, with 1 duplicate information for producer files and 3 other copies to be submitted to the official according to the provisions:

General

Food files, beverages, and food additives are put in a red snelhecter folder.

Diets of diet food are put in a green snelhecter folder.

Beams of functional foods and genetically modified foods are put into a blue snelhecter map.

ODS (One Day Service)

Food files are placed in a transparent blue snelhecter folder.

Beverage files and food additives are placed in a transparent red snelhecter folder.

  1. BPOM Licensing Registration for Domestic Food Products In

addition to the minimum requirements above, you are also required to attach a number of duplicate files to three registration application forms (forms A, B, C, D) that you have filled out.

Form A – attach using a paper clip

of trade mark from the Ministry of Justice of the Republic of Indonesia (if any).

Label design; color according to the plan to be used on the related product.

Photocopy of Industrial Permit from the Ministry of Industry and Trade (Disperindag) or the Investment Coordinating Board (BKPM).

Local BPOM Inspection Letter (if it has been checked).

Photocopy of Pharmaceutical Production Permit and CPOB certificate (Good Manufacturing Practices), specifically for food supplement products.

SNI Certificate (Indonesian National Standard) from the Ministry of Industry and Trade, specifically for bottled water and salt products.

Certificate (SK) from the original factory, specifically for products that are repackaged.

Certificate (SK) from the original factory, specifically for licensed products.

Form B – attach using paper clip

Specifications for raw materials and BTM (Food Additives).

Origin of the purchase of raw materials and BTM (Food Additives).

The standard used by the factory.

Container and lid certificates.

Test packaging and description of raw materials, specifically for food supplements.

Form C – attach using a paper clip

Production process from raw materials to finished.

Plant and employee hygiene & sanitation.

Plan and map of factory location.

Form D – attach using paper clip

Organizational structure.

Quality Control Systems, Facilities and Equipment for Quality Control.

The complete product analysis results include physical, chemical, BTM (Food Additive) checks according to each type of food, microbial contamination, and metal contamination.

If examined in the laboratory itself, must be equipped with analytical methods and procedures used and attach a list of laboratory equipment owned.

If it is examined in a government laboratory or an accredited laboratory, it must be completed with the method used.

Quality control in process control during the production process.

Also Read:

Must Know! 5 Tips for Successful Start of Your Batik

Business Business Becomes Sweet Selling Thanks to Attractive Merchandise

  1. Overseas Products (Imports)
  2. Requirements for Registration of Imported Products

Unlike domestic products, there are special files that must be prepared as a minimum requirement for BPOM licensing for imported products, namely:

Letter of appointment from the original factory, prepare original documents and photocopies for attachments.

Health Certificate or free sale from the authorized agency in the country of origin, prepare original documents and photocopies for attachment.

The results of the original laboratory analysis (valid 6 months after the test date), relating to nutritional products, substances claimed according to the label, chemical tests, microbiological contamination, and metal contamination.

Design the label in accordance with what will be circulated and product samples.

Complete registration form.

Specifically for ODS (One Day Service), a letter of approval for similar products and labels that have got a registration number must be attached.

Forms that have been filled out, then reproduced 4 copies each, with 1 duplicate information for the manufacturer’s archive and 3 other copies to be submitted to the officer in accordance with the provisions:

General

Files of all products are put in a yellow snelhecter folder.

ODS (One Day Service)

Files of all products are placed in a yellow transparent snelhecter folder.

  1. BPOM Licensing Registration for Imported Food Products

In addition to the minimum requirements above, you are also required to attach a number of duplicate files on several registration application forms (forms A, B, C, D) that have been filled out by the original factory or legalized according to the guidelines.

Form A – attach using paper clip

Trademark certificate from the competent authority (if any).

Health Certificate or free sale from the authorized agency in the country of origin.

Radiation free certificate.

Letter of appointment from the original factory.

Label design; color according to the plan to be used on the related product.

Form B – attach using a paper clip

Composition from the original factory.

Specifications of origin of raw materials and BTM (Food Additives) from the original factory.

Certify the container and cover from the original factory.

Standards used from the original factory.

Test packaging and description of raw materials, specifically for food supplements.

Form C – attach using a paper clip

Production process from raw materials to finished.

Form D – attach using paper clip

Quality control system from the original factory.

The complete product analysis results include physical, chemical, BTM (Food Additive) checks according to each type of food, microbial contamination, and metal contamination.

If examined in the laboratory itself, must be equipped with analytical methods and procedures used and attach a list of laboratory equipment owned.

If it is examined in a government laboratory or an accredited laboratory, it must be completed with the method used.

Quality control in process control during the production process.

Examples of Related Food Products – 3 (three) pieces / packaging

Note: The applicant can include other documents that can support the assessment of the application.

Also Read:

5 Companies That Failed But Revived

Strategies to Enter Foreign Markets Through Social Media

III. One Day Service (ODS)

Sub Directorate of Food and Beverage Evaluation and Registration provides a service and rapid assessment system within 24 hours, with the aim of increasing the effectiveness and efficiency of the application for registration & assessment.

Especially for low-risk food products, both local and imported, which are registered directly with BPOM.

Low-risk food product requirements are foods that are not directly consumed or are still undergoing further processing, high sugar content, water activity (aw) below 0.85, high packaging (pH below 4.5).

  1. ODS Product Rating Parameters

Form A; filled out by the applicant correctly and completely in accordance with the guidelines.

Attachments for domestic products:

Industrial licenses or industrial registration marks from the Ministry of Industry and Trade (for new factories and new product types)

Trademark certificates or patent numbers for products using the “R” code in trade names.

SNI certificate for iodized salt or claimed product according to SNI.

Design labels according to guidelines.

Examples of products (3 pieces).

Certificate from original factory, for repackaging factory.

Certificate of factory licensing from the country of origin, for licensed factories.

Attachments for imported products:

Letter of appointment of the importer from the original factory, or a copy that is legalized by the importer by showing the original file.

Health Certificate or free sale, or a copy legalized by the importer by showing the original.

Examples of original labels with label designs according to what will be circulated.

Examples of products (3 pieces).

Label, with provisions:

Label design in accordance with the product to be circulated (in duplicate).

The main part of the label must contain the product name, net weight / net, manufacturer / importer name and address (city name, zip code; full address), and registration number.

Other information on the label contains composition, BTM class, name of preservative, sweetener, coloring complete with color index (if used), expiration date, production code, production date, as well as other information that must be listed according to the law.

Completeness of filling in form B, including:

List and amount of raw materials & BTP used, name of BTP and its uses, Color Index (CI) if using dyes, as well as origin of raw materials & BTP used.

Completion of filling out form C, including:

How to make

the production process Scheme

Completion of filling form D, including:

Results of final production analysis.

Registration time starts at 09:00 – 13:00.

  1. ODS Product Requirements

Overseas products with ML code:

Letter of appointment from the country of origin of the

Health Certificate or free sale from the local Ministry of Health or country of origin.

Laboratory Test Results.

Colored label.

Examples of products (three).

Composition and specifications.

Trading Business License (SIUP) and Import Identification Number (API-U).

Domestic product with MD code:

Trade Business License (SIUP) or principle permit.

Laboratory Test Results.

Patented colored labels.

Examples of products (3 pieces).

Also read: Procedures for Managing a Trade Business License (SIUP)

  1. Flow of BPOM Permission Registration The

following is the flow of BPOM licensing registration, see how the process is!

The registrant submits a written registration application by filling out the form and attaching supporting data.

Applicants submit 2 copies of the request (original and photocopy) to the Head of BPOM cq Director of Food Product Standardization.

Check the application registration form in accordance with the criteria, requirements, and determination of the evaluation fee.

Application for registration of processed food in the context of evaluation to obtain a distribution permit from BPOM or changes in processed food data, will be charged as PNBP (Non-Tax State Revenue) in accordance with the provisions of the Act.

BPOM Circular Permit that has been issued is valid for a period of 5 years and can be extended through re-registration.

 
Translate »