Not only does Indonesia majorly export oil and gas but the archipelagic state is also where the food and beverage industries flourish progressively.

 

There is no wonder that the sectors are seriously watched and highlighted by the local government. In consonance with cekindo.com, the annual turnover of Indonesia’s food and beverage industry successfully reached up to 82 billion USD in 2013. Meanwhile, the sales of soft drink have an increase of compound annual growth rate amounted 9.3% from 2014 to 2018.

 

However, the trading activities can’t be completely implemented before the Indonesian authority provides the distribution permit. If you find some trouble dealing with that, it is recommended that you rely on a credible law firm like BP Lawyers.

 

 

Regulation about Distribution Permit for Food and Beverage in Indonesia

Speaking of the foods, it has been clearly specified that all the things about them from production to distribution refer to the Law no. 18/2012 better known as Food Law. According to the Food Law, food is defined as any products from biological sources from agriculture, farm, plantation, forestry, as well as marine environment.

 

The condition of food alone is regulated by Law no. 28/2004 recognized as Food Safety, Quality, and Nutrition (GR 28). This regulation mainly focuses on the food’s hygiene, foods having been genetically modified, food guarantees, food packaging, the quality of food and certification, food irradiation, the nutrition content of food, food exportation and importation. Also contaminated food, the food analysis conducted in a laboratory, as well as supervising food allowing the public to get involved with the control.

 

Those edible goods – both foods and beverages – are strictly supervised by an agency popularly known as the Food and Drugs Supervisory Agency or BPOM (Badan Pengawasan Obat dan Makanan in Indonesian). The provision of the distribution permit of the imported food and drug is compatible with the Law no. 27 of 2013. What about the alcoholic beverage? The distribution of liquor or alcohol-related drinks is based on the president regulation no. 74 the of 2013.

 

In advance of food product distribution, the companies should ensure that their food and beverage products are successfully registered by way of Food and Drugs Supervisory Agency or BPOM. Unfortunately, the foreigners have no capability of doing this. It is vital that they have the local agents or distributors do the registration. The process of it might be short or might be lengthy depending on the type of imported products. The range is from 2 to 3 months.

 

The food and beverage registration can’t be apart from the existence of halal certification. The term of halal points out the Islamic regulation. The clause about how your products need to be halal-certified is an optional thing – it’s not mandatory. However, the Indonesian government keeps urging the business entities to do in accord with the administration program named “wajib halal 2019”.  The halal registration is clearly regulated by the Law no. 33 of 2014.

 

 

 

 

A Distribution Permit for Medical Device

 

In the name of public’s safety associated with the health sector, the Indonesian government issues the regulation about the distribution permit of the medical device.

 

Corresponding to Law no. 36 of 2009, the medical device in Indonesia can’t be distributed unless it is fully registered. The ministry of health of Indonesia classifies the risk of the medical device into four types that include low risk (level 1), medium risk (level 2), middle risk (level 3), as well as high risk (level 4).

 

Before getting the approval, the medical device should go through the process of evaluation and examination. These ways determine how safe and good the equipment is. Besides, the license will be entirely obtained if the tools meet the basic requirements described in three words – safety, quality, and efficacy. This provision applies to either exported or imported goods.

 

Once the distribution permit is acquired, the official permit number should be listed in the medical product’s package and leaflet.

 

How about the writing order concerning the number of the medical device’s distribution permit? If the equipment is locally produced, the order should be KEMENKES RI AKD XXXXX. Meanwhile, the imported product should be written in KEMENKES RI AKL XXXXX. And how long does the process to get the license take place? Any medical companies should underline that processing time is relative depending on the risk of the medical device inflicted.

 

 

 

 

Regulation of BPOM’s Distribution Permit

When the products of food and beverage of yours are about to get distributed in Indonesia, always bear in mind that you have to gain permission from Food and Drugs Supervisory Agency or BPOM.

 

Is it that hard to let them registered? The answer is, overall, not that tough as long as the packaging label contains information by the standard set by the local government – this one is obviously specified in Law no. 99 of 1999.

 

Food and Drugs Supervisory Agency will inspect and evaluate the food and beverage products as well as the information on the label. A label is considered great if it includes the name of the product, the main ingredients and composition, and net weight. In addition to them, the additional points such as the date of manufacturing, the expiration time, and the address of the distributor can’t be thought little of.

 

The condition in which the Food and Drugs Supervisory Agency or BPOM deters you to get the distribution permit is when the food and beverage products are comprised of ingredients endangering the human’s health or do not meet the standard requirement from the ministry of health. If the worst case continues, BPOM has a right to do the further steps such as giving the warning (reprimanding) and even suspending the license or distribution permitted.

 

 

 

 

Registration of Medical Device

 

The registration of medical device begins when the applicants enroll their company and do the online registration using regalkes.depkes.go.id.

This early step comes with an objective to acquire the user ID and password as well. Once the form appears, the applicants should fill in it as the prerequisite requirement. The ID card is needed when the offline approach is taken.

 

At the bottom, there are two stages in the registration of medical device. The early phase is called class determination. The purpose of class determination is to verify the classification of the medical equipment, and the same is true with the cost that the applicants have to pay.

 

After filling out the form on the official webpage of the ministry of health, the people need to check out their email address for the follow-up. To be quickly replied, it is essential to provide your company’s information properly and correctly.

 

The department will immediately send the notification once you’ve applied. The evaluators then take their job by checking out and sorting the medical device. Apart from the notification of your application status, the applicants are informed about the total cost that should be paid and how to pay.

 

Concerning the payment, the individuals applying for a permit must upload the receipt no later than ten days. You have to underline that this phase is where the evaluation process has yet to carry out.

 

The second phase refers to the evaluation process. During this stage, the authority evaluates and assesses the standard of equipment’s quality and safety. The rationale why the approval should be given is also taken into account. When the applicants successfully upload the payment proof, the following step is to submit the documents to the office. The result of the evaluation process will soon be notified online.

 

 

 

 

A Distribution Permit for Traditional Medicine in Indonesia

The traditional medicine in Indonesia is specifically regulated in the law of Indonesian health ministry year 2012. According to the related authority, traditional medicine is defined as an ingredient that originates from plants (herbs) or animal’s parts and is completely processed into a concoction for medical purpose. Like foods and beverages, the distribution of traditional medicine should be legal – a license needs to be acquired.

 

The companies that produce the traditional medicine are supposed to understand that their products should be in line with the term of CPOTB (Cara Pembuatan Obat Tradisional yang Baik). This definition refers to the manufacturing method of the medicine which the producers must think over the consumers’ safety and quality standard. Other terms related to this industry include IOT, UKOT, as well as UMOT.

 

What about the registration process? It is arguably effortless as long as you conceive the administration and technical requirements. For the administration one, you are encouraged to provide a couple of significant documents that include the copy of your business license, a copy of diploma, a letter of statement confirming a person in charge, the sample of listed traditional medicine, the design of printed tagging, and the sample of raw ingredient.

 

Speaking of the technical requirement, the producers should include the product’s composition (be it the raw ingredient of the total amount), the efficacy (according to science literature), and the usage (the dose, warning, advice, and use duration should be included). Other things to mull over embrace the way of manufacturing, outsourcing, assessment of the quality of raw ingredient and durability, and not to mention the evaluation of the ready-to-use product.

 

 

 

 

The Government’s Regulation regarding Distribution Permit for Drug and Food

The government’s regulation dealing with the control and distribution of drug and food by way of BPOM (Food and Drugs Supervisory Agency) is evidently specified in Law no. 27 of 2013. There are a couple of points to pay attention after it is issued. This law defines the term of drug and food.

 

The items, in essence, refer to any types of products encompassing traditional medicine, general medicine, processed foods, food supplement, as well as cosmetics.  It also administers the imported drug and food.

 

Based on the governmental ordinance, a medicine is characterized by the biological product originating from the edible ingredients. It is scientifically proven to have an ability to investigate the physiology system so that it can be used for curing the illness as well as boosting the immune system.

 

Meanwhile, the traditional kind is made up of substances obtained from plant, animal, or mineral. Vaccine, antigen, and enzyme are categorized in the biological products.

 

Processed foods are indicated by foods and beverages of which manufacturing process with or without additives. What about food supplement? It is highlighted by the presence of a product that is capable of nurturing, nourishing, and maintaining the human’s health, and complementing the nutritional need. And the last term is no other than cosmetics. They are deeply related to the ingredients mostly used for the outer part of the human’s body such as skin and hair.

 

To acquire the distribution permit, the food and drug should come with the decent packaging label that meets the required standard stipulated by the Indonesian government. This provision has been clarified in Law no. 96 of 1999 about food and label advertisement. The proper label must provide accurate information such as the brand, the list of used ingredients, manufacturer’s address, and expiry date.

 

 

 

 

BPOM and Distribution Permit

Arguably, BPOM and distribution permit are deeply associated each other. Corresponding to the most up-to-date presidential regulation specified in Law no. 80 of 2017, BPOM (Food and Drugs Supervisory Agency) plays a significant role to arrange the national policy about the distribution of food and drug in Indonesia, issuing and revoking the distribution permit in the shape of license and certification.

Also evaluating and inspecting the products, auditing the advertisement on a product, even granting sanctions against the lawbreakers. The agency also educates people about food and drug.

 

 

 

Is It True that BPOM Restricts the Distribution Permit?

After the issues about products containing pork fat (considered non-halal), the Indonesian Food and Drugs Supervisory Agency or BPOM strive to protect the Muslim consumers. One of the tangible ways that this legal entity carries through is by restricting the distribution permit. BPOM intensively modifies the strategy.

Erenow, the department was prone to push forward the process of distribution permit. This measure likely does not indicate the department’s seriousness toward the consumers’ protection.

The serious act of BPOM can be traced by observing the process of evaluation and assessment. Unlike the previous examination, today’s laboratory test is more comprehensive. In addition to that, BPOM keeps improving their work by strictly asking the importers to ascertain that their products are safe, healthy, and meet the standard supposedly. The agency makes the importers obey the rule about the proper packaging. In this case, the related people are banned from listing non-halal label – a pig figure for instance.

 

 

 

Requirements to Gain the Distribution Permit

The requirements to acquire the distribution permit from BPOM do depend on the types of your products – local products and imported products. If yours belong to the first category, you are required to provide – at least – a copy of industrial license from an institution named BKPM (Badan Kordinasi Penanaman Modal), a certificate of laboratory analysis of finished product  (it has 6-month validity), the label design (according to the product sample), and the filled-out registration form.

What about the imported products? The applicants need to prepare a couple of documents that include a certificate of free sales from the origin country (a health certificate is also permissible), a letter of appointment from the origin factory, a certificate of laboratory analysis of finished product (the 6-month validity starts from the date of examination), as well as the registration form having been completely filled in.

The decision after the evaluation varies – it can be denied, approved, or approved with a particular condition.

During the registration process, BPOM offers three types of services (they determine how fast the evaluation takes place). The general service is a common assessment of the high-risk product. The ODS kind (One Day Service) is the evaluation of the product that already meets the basic requirement with the decision relatively-faster. And re-registration service is typically addressed to the products with the expiry license.

 

 

 

 

The Difference between Distribution Permit Issued by BPOM and the One by DINKES

 

The place of BPOM is nothing but supreme. The only institution is responsible for watching and regulating the distribution of food, drug, and beverage in Indonesia. All food and drug companies should ensure that their products are fully registered in BPOM. What about DINKES? It turns out that DINKES has no authority to issue the distribution permit. The department of health is competent to put out SP code and PIRT code.

The code of SP (Sertifikat Penyuluhan) is only given to the small business while the code of PIRT is provided for any food and beverage of which durability is more than seven days. The products normally include canned food, bottled water, and frosted food.

To make a long story short, a distribution permit is required to guarantee that the food, drug, and beverage are safe and excellent so that the consumers in Indonesia are fully protected. If you need some assistance regarding this matter, just reach out your credible law firm.

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