Marketing, Manufacturing, Packaging & Labeling, Advertising
The ins and outs of marketing, manufacturing, packaging & labeling, and advertising in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for USD 99.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products?
Any marketing of drugs (including biologics and over the counter medications) within Indonesian territory require a registration process with BPOM to obtain an MA . The registration must only be made by Indonesian pharmaceutical manufacturing companies, including those that are subsidiaries of foreign pharma companies.
In general, the registration process for new products is classified into three categories as follows:
- Category 1: registration of new drugs and biological products, including biosimilar products;
- Category 2: registration of generic drugs and generic drugs with trade mark;
- Category 3: registration of other supplies containing drugs with special technology, which may be in the form of transdermal patch, implant and beads.
The process generally consists of two stages, namely preregistration phase and registration phase. The preregistration phase is required to filter the registration process of the drugs, covering stipulation of the registration category, evaluation track, evaluation fee, and registration documents.
Any registration of new product must include risk management planning. Detailed information on the procedures and requirements for registration of new product in BPOM is as stipulated under BPOM Regulation No. 24 of 2017 regarding Criteria and Guidance for Registration of Drugs (“BPOM Regulation 24/2017”).
Upon application for registration to BPOM, several evaluations will be performed by certain committees established by BPOM on the following criteria:
- Reliable efficacy and adequate safety, as evidenced by the non-clinical and clinical testing as well as other evidence;
- Quality, including compliance of production process with the Good Manufacturing Practices (“GMP”) for drugs;
- Product information and labelling;
- Other specific criteria for psychotropic and contraception medication.
The MA will be issued by BPOM based on the recommendation provided by the committees and/or on-site investigation result. Upon obtaining the MA, applicant is obligated to produce or import and distribute the drugs at the latest one year as of the issuance of the approval.
Pursuant to MOH Regulation No. 62 of 2017 regarding MA of Medical Devices, In Vitro Diagnostic Medical Devices and Household Health Supplies (“MOH Regulation 62/2017”), any medical devices, in vitro diagnostic medical devices and household health supplies to be manufactured, imported, assembled and/or repackaged for distribution in Indonesia must obtain MA.
To be granted with WA, medical devices must meet the following criteria:
- Quality, in accordance with the good manufacturing practices;
- Safety and benefits, as evidenced by clinical test result and/or others;
- The dose does not exceed the specified level limit in accordance with applicable standards, requirements and conditions; and
- Do not use materials that are prohibited in accordance with applicable standards, requirements and conditions.
Based on the risk for usage, medical devices are classified into four categories:
- Class A: medical devices with low risk;
- Class B: medical devices with low risk to medium risk;
- Class C: medical devices with medium risk to high risk;
- Class D: medical devices with high risk.
The application of MA for domestically manufactured medical devices must be submitted by a licensed manufacturer. Applications for imported medical devices may be made by sole/exclusive agent/distributor or licensed distributor.
The application must be submitted online through the Online Single Submission (“OSS”) system. During the process, applicant will be required to submit certain supporting documents to the website of MOH (regalkes.kemkes.go.id) as fulfillment of the application requirements.
The application will then be assessed and evaluated by the MOH. If the medical devices use a new technology or active substances and/or have unusual claim, the application must be supported with consideration from an expert team established by the MOH. Upon fulfillment of the administration and technical requirements, the MOH will issue a notification on compliance with the MA requirements, which will then activate the MA issued by the OSS system.
2. What is the authorization process for the marketing of generic versions of these products?
The authorization process for marketing of generic drugs in Indonesia is generally the same as the registration of new product in BPOM (see our response to question 1 of Chapter 3 above).
Below are some specific requirements for the registration of generic drugs under BPOM Regulation 24/2017:
- The registration of generic drugs must use generic name in accordance with the International Nonproprietary Names – Modified as set out by the World Health Organization or names as stipulated in the national health program.
- All manufacturing stages of generic drugs must be done locally, save for a manufacturing stage that cannot be performed locally.
- Labelling of generic drugs must contain information on the highest retail price in accordance with the prevailing regulations, and generic logo in green with the prescribed format as set out under the regulation.
3. What are the typical fees for marketing approval?
Please see Chapter 1 Question 4.
4. What is the period of authorization and the renewal process?
MA for drugs is valid for 5 years and may be extended as long as the product meets the provisions of the prevailing regulations.
The application for extension (re-registration) of MA must be made to BPOM at the earliest 12 months and at the latest 2 months prior to the expiry of the validity period of the MA, save for re-registration of MA with no changes that may be applied for at the latest 1 month prior to the expiry date of the MA. Detailed information on the procedures and requirements for re-registration in BPOM is as stipulated under BPOM Regulation 24/2017.
The approval of re-registration of MA shall be valid as of the expiry date of the existing MA.
MA for medical devices is valid for 5 years and may be extended as long as the product meets the provisions of the prevailing regulations.
The application for extension of MA must be applied at the soonest 6 months prior to the expiry of the license. Detailed information on the procedures and requirements for extension of MA is as stipulated under MOH Regulation No. 26 of 2018 on Electronically Integrated Business Licensing Services in Health Sector (“MOH Regulation 26/2018”).
5. What are the requirements, if any, for post-approval pharmacovigilance?
The implementation of pharmacovigilance in Indonesia is set out under BPOM Regulation No. HK.03.1.23.12.11.10690 TAHUN 2011 on Implementation of Pharmacovigilance for Pharmaceutical Manufacturers.
Pursuant to the regulation, a pharmaceutical manufacturer is required to implement pharmacovigilance through supervision of the following:
- Safety aspect of the drugs for detection, assessment, understanding and prevention of side effect or other matters related to usage;
- Change to the profile of benefits-risks of the drugs; and/or
- Quality aspect that affects the drugs’ safety.
If during the implementation of pharmacovigilance, the manufacturer finds that the drugs and/or drugs raw materials it manufactured do not meet the standard and/or requirements on safety, efficacy/ benefits, and quality, the manufacturer is obligated to report the finding to BPOM.
6. Are foreign MAs recognized?
No, a foreign MA is generally not recognized as an independent permit in Indonesia.
Any drugs, either domestically manufactured or imported drugs, as well as medical devices to be distributed within Indonesian territory must follow the registration procedures and obtain MA issued by BPOM, or MOH for medical devices. Nonetheless, a foreign MA (in the form of Certificate of Free Sale) is required as one of the supporting documents in the application of MA for imported medical devices.
7. Are parallel imports of drugs or devices allowed?
Yes, parallel import of drugs is allowed in Indonesia.
Pursuant to the Indonesian Patent Law (i.e., Law No. 13 of 2016), parallel import of drugs is exempted from criminal provisions under the law and civil claims, provided that the drugs are imported in accordance with the prevailing laws and regulations. The provision is aimed to guarantee fair prices and fulfill the sense of fairness of all pharmaceutical products that are necessary for human health. The provision should be used if the price of product in Indonesia is extremely high compared to the prices that are legally circulated within the international market.
The law, however, is silent on the parallel import of medical devices. Conservatively, the implementation of parallel import of medical devices is not allowed in Indonesia.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
In general, the Indonesian Consumer Protection Law (i.e., Law No. 8 of 1999 concerning Consumer Protection) prohibits any offering, promotion or advertising of drugs, traditional drugs, food supplements, medical/health devices, and health services by promising the granting of gift of goods and/or services.
Based on the Decree of Head of BPOM No. HK.00.05.3.02706 of 2002 on Promotion of Drugs (“Decree No. 02706”), granting cash to doctors constitutes one of the prohibited forms of promotion. Decree No. 02706 restricts pharmaceutical industries to grant a bonus/gift in the form of money (cash, bank-draft, loan, voucher, ticket) and/or goods (free samples) to the prescribers (doctors) of the drugs produced by the pharmaceutical industry. Violation of this restriction is subject to the following administrative sanctions:
- Written warning;
- Temporary suspension of activity;
- Temporary suspension of/or revocation of the MA of the respective drugs; and/or
- Administrative sanctions in accordance with the prevailing laws and regulations.
Further, if the doctors receiving monies from the company are civil servants or state administrators, the payment will also be subject to the anti-bribery laws (Law No. 31 of 1999, as amended by Law No. 20 of 2001 on the Eradication of Corruption).
Based on the Law, any gratuity to civil servants or state administrators is considered bribery if it is related to their job responsibilities and contrary to their duties or obligations. Gratuities are defined broadly, and can include money, goods, airline tickets, accommodation, discounts, loans, commissions, and other facilities. Civil servants or state administrators who receive a bribe are subject to criminal sanction of imprisonment for 4 to 20 years or even life, and a fine from IDR 200 million to IDR 1 billion. However, the provision is not applicable if the civil servant or state administrator reports the gratuity to the Corruption Eradication Commission (“KPK”) within 30 days of receiving it. KPK will then determine whether the gratuity may be kept by the receiving civil servant or state administrator or be confiscated by the state.
If it is proven that the gratuity was made by the pharmaceutical company with the intention that the civil servant or state administrator:
(i) would or would not carry out an act, or
(ii) has already carried out or not carried out an act,
related to their job responsibilities and contrary to their obligations, the company (including the recipient of such gratuity) may be imposed with criminal sanction of imprisonment of 1 to 5 years, and a fine of IDR 50 to 250 million.
With regard to the sponsorship to healthcare professionals, the MOH issued Regulation of the Minister of Health No. 58 of 2016 on Sponsorship of Healthcare Practitioners which requires all healthcare professionals to report any receipt of sponsorship from pharmaceutical or medical devices industries.
9. How is the manufacturing of drugs and devices regulated and by which agencies?
The manufacturing of drugs is regulated by MOH under its Regulation No. 1799/MENKES/PER/XII/2010 on Pharmaceutical Industry, as amended by MOH Regulation No. 16 of 2013 (“MOH Regulation 1799/2010”).
Pursuant to the regulation, the manufacturing of drugs may only be performed by: (i) a pharmaceutical manufacturer with a valid manufacturing license from the MOH; and (ii) a hospital pharmaceutical installation to support health services in the relevant hospital.
MOH Regulation 1799/2010 provides specific requirements that must be fulfilled by a pharmaceutical manufacturer in manufacturing drugs, including to comply with the GMP for drugs and obtain a certificate of GMP from BPOM, as well as to perform pharmacovigilance and report to BPOM if the drugs do not meet the security standards and/or requirements, efficacy/benefits and quality.
For medical devices, the manufacturing of the products is also regulated by MOH under its Regulation No. 1189/MENKES/PER/VIII/2010 regarding Manufacturing of Medical Devices and Household Health Supplies (“MOH Regulation 1189/2010”).
Based on the regulation, the manufacturing of medical devices may only be performed by a company having a certificate of production issued by MOH. The requirement to obtain certificate of production also applies to a company that will engage in the repackaging, assembling, recondition/remanufacturing and company that manufacture medical devices by order and for the trademark or formula owner (tolling).
A manufacturer of medical devices shall be responsible for the quality, safety and benefits of the medical devices that it manufactured. They shall also guarantee that the product is manufactured in accordance with the GMP for medical devices and that there is no decrease in quality and performance of the product during the storage, usage and transportation process.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Drugs Agency?
Indonesia has developed its own standard of GMP for drugs as regulated under BPOM Regulation No. 34 of 2018 concerning Guidelines on GMP for Drugs (“BPOM Regulation 34/2018”), which covers several aspects from quality system of pharmaceutical manufacturer, personnel, buildings and facilities, equipment, production, quality control, documentation, self-inspection, computerized system up to quality risk management.
The requirements under Indonesian GMP has followed the international standard and may or may not be compatible with the U.S. Food & Drug Administration and/or the European Drugs Agency.
11. What is the inspection regime for manufacturing facilities?
BPOM Regulation 34/2018 introduced a self-inspection program in manufacturing of drugs for the purpose of evaluating whether all manufacturing aspects and quality control of the pharmaceutical manufacturer are in compliance with the GMP provisions. The self-inspection program must be performed independently and in detail by competent officers from the company that can objectively evaluate the implementation of GMP, regularly and in specific situations.
Inspection of a pharmaceutical manufacturer shall also be done by BPOM. In performing its duty, relevant officers of BPOM may conduct the following actions:
- Enter into places used for manufacturing, storage, hauling and trading activity of drugs to examine and take samples of everything used in such activities;
- Open and examine drugs packaging;
- Examine documents and other records that allegedly contain information regarding manufacturing, storage, hauling and trading activity of drugs, including doubling or quoting such information; and/or
- Take pictures (photos) of all or part of the facilities and equipment used in manufacturing, storage, hauling and trading activity of drugs.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
As far as we are concerned, there is no restriction for inspection of manufacturing facilities of drugs by foreign inspectors or third-party inspectors authorized by the FDA/EMA under the prevailing regulations.
However, any inspections by foreign inspectors in Indonesia must also comply with the requirement imposed by the Ministry of Manpower and Directorate General of Immigration in relation with the working permit of the expatriate inspectors.
13. What are the requirements for storage, packaging, and handling of drugs and devices and their constituent components?
The specific requirements for storage, packaging, and handling of drugs and their constituent components are set out under BPOM Regulation 34/2018 (for manufacturers) and BPOM Regulation No. HK.03.1.34.11.12.7542 TAHUN 2012 on Technical Guidance on Good Distribution Practice for Drugs (for distributors).
In general, drugs and their constituent components must be stored neatly and orderly by a manufacturer in a storage area to prevent contamination and to facilitate inspection and maintenance. Outside storage is allowed for materials that are packed in impermeable containers (for instance, metal drums) provided that the quality will not be affected by temperature or other conditions.
For distributor, the storage condition must be in accordance with the recommendation from pharmaceutical manufacturer or non-pharmaceutical manufacturer that manufactures the drugs materials to pharmaceutical quality standard. The volume of the drugs and drugs materials ordered must take into account the capacity of the storage facility.
Packaging of drugs should be carried out under strict supervision to maintain the identity, wholeness and quality of the final product being packaged. The filling and closing process in packaging stage should be immediately followed by labelling. Otherwise, proper procedures should be applied to ensure that there is no mix-ups or mislabelling. All packaging personnel should receive training to understand the supervision requirements during the process and report any deviations found when they carry out these specific responsibilities.
As for medical devices, the requirements for storage and handling of medical devices are set out under MOH Regulation No. 20 of 2017 on GMP for Medical Devices and Household Health Supplies (for manufacturer) and MOH Regulation No. 4 of 2014 on Good Distribution Practices for Medical Devices and Household Health Supplies. There must be an adequate storage facility to guarantee that the products are stored properly. This includes a storage room for raw material/ packaging/ component, intermediate product, and finished product in the manufacturing facility, and storage room designed for products worthy of selling, quarantined (rejected) products, recalled/returned products, and expired products in the distribution facility.
14. What information must be included in drug and device labelling?
Based on Government Regulation No. 72 of 1998 on Safety of Pharmaceutical Supplies and Medical Devices (“GR 72/1998”), the labeling in drugs and medical devices must generally include the following information:
- Name of product and/or trademark;
- Name of business entity manufacturing or importing the drug or device into Indonesian territory;
- Main components of the drug and device;
- Procedure for usage;
- Warning signs and side effects;
- Expiry date for particular drugs.
This mandatory information in the labeling must be made in writing, containing objective, complete and not misleading information on the product. Other information in the labeling can also be made in the form of images, color, writing or a combination of all three or other forms to be included in the packaging or put into the packaging, or is a part of the packaging.
The information must be available in Indonesian language.
BPOM provides a comprehensive list of minimum information that must be contained in each type of labeling of drugs as detailed in the Attachment XI to BPOM Regulation 24/2017. Based on the list, the information required in the labeling of drugs include, among others:
- Type of drug;
- Form of drug;
- Size of packaging (unit);
- Name and strength of active substance;
- MA number;
- Batch number;
- Production date;
- Drug interactions;
- Special warnings, such as “requires prescription”, contains pork, alcohol content, etc.;
- Special label, such as logo for type of drug (OTC drug, prescription drug), logo for generic drug, highest retail price, etc.
Pursuant to MOH Regulation 62/2017, the labelling of medical devices must at least contain the following information:
- Trade name / mark;
- MA number;
- Type of product;
- Name and address of the manufacturer;
- Name and address of the distributor having the MA;
- Batch number/ production code/ serial number;
- The word “sterile” and sterilization method for sterile product;
- Product specification;
- Purpose and guidance of usage;
- Expiry date for product with expiration date; and
- Warning label of “may only be used by professional staff” or symbol of “p” in white with black background for certain medical devices that must be used by expert.
The labeling of medical devices must also contain information on net, composition and active substances level, contraindication, attention and warning signs or side effect, if any.
15. What additional information may be included in labelling and packaging?
Please see our response to question 36 of Chapter 3 above. Pursuant to GR 72/1998, information that may be included in labeling and packaging of drugs and medical devices is limited to information contained in the MA of the relevant product.
16. What items may not be included in labelling and packaging?
In general, items that may not be included in labelling and packaging are those not stipulated in the MA of the relevant product.
Specifically for medical devices, MOH Regulation 62/2017 provides that the labeling should not contain the following wordings
- Superlatives, such as “most”, “very”, “super”, “top, “magic”, etc.;
- Wordings such as “germ-free”, “mosquito-free”, “safe”, “extermination”, “anti-aging”, “cure”, “aromatherapy”, “recommended by doctors”, etc.;
- Percentage or other statement to indicate product effectivity;
- “anti-bacterial” claim which is not the main function placed at the front of the labeling;
- “insect repellent” claims;
- Include the function of additives as the main claim;
- Include the name of the testing laboratory; and/or
- Include a claim that is not in line with the function of the active substance as the main claim.
17. What are the restrictions and requirements for the marketing and advertising of drugs and devices?
BPOM Decree No. 02706 provides general requirements and restrictions for marketing and advertising of drugs, aiming to protect public from the risk of improper use of drugs due to excessive, inappropriate and/or misleading promotion of drugs.
The promotion of drugs to public through print media, electronic media and/or outdoor media is only allowed for OTC drugs. Whilst, any promotion of prescription drugs cannot be made to general public.
Narratives and efficacy claims used for the promotion of drugs should be in line with the claims approved by BPOM under the relevant MA.
Below are several restrictions under BPOM Decree 02706 for the promotion of drugs by pharmaceutical manufacturer and/or distributor:
- entering into cooperation with pharmacies and prescription makers;
- entering into a cooperation on prescription of drugs with pharmacies and/or prescription makers in a special program to increase sales for particular drugs;
- To give bonuses/prizes in the form of money (cash, bank-draft, loans, vouchers, tickets) and/or goods to the prescription makers which prescribes drugs produced or manufactured by the manufacturer/distributor;
- To form a special group to increase use of drugs that relates to marketing objectives;
- To conduct promotion with prizes for the sale of OTC drugs, by returning the former packaging and/or holding a quiz or something similar.
Specific guideline on advertising of drug is stipulated under MOH Decree No. 386/Men.Kes/SK/IV/1994 concerning Advertising Guideline: OTC Drugs, Traditional Drugs, Medical Devices, Cosmetic, Household Health Supplies and Foods-Beverages (“MOH Decree 386”) and BPOM Regulation No. 8 of 2017 on Guideline on Drug Advertising Supervisory (“BPOM Regulation 8/2017”). Provisions under both regulations include the requirement to obtain MA and prior approval from BPOM for advertising of drugs.
Specific requirements and restrictions on advertising of medical devices are stipulated under MOH Regulation No. 76 of 2013 regarding Advertising of Medical Devices and Household Health Supplies.
Pursuant to the regulation, medical devices may be advertised through print or electronic media, information technology and/or outdoor media. Specifically, for medical devices whose utilization requires assistance from professional staff, the advertising may only be done through scientific printed media for drugs and pharmaceuticals and/or a scientific forum for the health profession or similar.
The advertising of medical devices requires prior approval from the MOH and MA for the product.
Below are some restrictions on advertising materials for medical devices:
- Misleading through emphasis, striking comparison or omitting facts;
- Comparing to other similar product with demeaning intent;
- Directly or indirectly encourage the excessive and unnecessary use of medical devices;
- Taking advantage of public’s ignorance by listing scientific data that cannot be validated or verified;
- Causing fear or taking advantage of public myths;
- Provide testimonials;
- Use names, initials, logos, symbols and/or references which indicate suggestions for use from health institution or organizations;
- Use confusing medical jargon/slogans;
- Abuse research result or quotes from technical or scientific publications; and/or
- Directly or indirectly suggest that the medical devices may prevent disease.
In addition, the advertising material is also not allowed to:
- Contain wording, sentences or illustrations that claim or give the impression that the device may cure certain disorder or disease;
- Directly or indirectly suggest that the device may prevent, slow down or restore physiology changes and degenerative conditions that are related to aging;
- Contain claims or create the impression that the device is perfect, guaranteed to provide certainty on healing; and/or
- Ignores main treatment/care, offer specific suggestions, diagnosis or treatment for serious and chronic diseases.
Advertising for medical devices shall not contain or display health personnel or actor acting as health personnel or using attribute of health personnel, except for advertisements in health magazines, health services advertising, and scientific forum within a professional environment.
18. Where can drugs and devices be sold or delivered? Can drugs and devices be sold or delivered via post?
Save for prescription drugs, the sales of drugs in wholesale may only be carried out by a pharmaceutical distributor with specific license from the MOH. The retail sale/supply of drugs to end consumers is only allowed for pharmaceutical services facility, which includes pharmacy, hospital pharmacy, health center (puskesmas), clinic, or drug store. Specifically for drug stores, the sales activity is limited to OTC drugs.
As for medical devices, the wholesale distribution must be carried out by a medical devices distributor with a specific license from the MOH. While the retail sales should be done by medical devices store (for devices that cannot cause harm and do not require supervision from health personnel in its utilization), or a health services facility or authorized health personnel (for devices whose utilization requires supervision from health personnel). Certain medical devices in limited quantity may also be sold to end consumer by pharmacies and licensed drugs retailers.
Given the specific requirements for the delivery of drugs as provided under the relevant regulations, it is very unlikely to sell or deliver products via post.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?
BPOM Regulation 8/2017 only acknowledges two types of electronic media for promotion of drugs, namely television (including running text) and radio. Hence, utilization of electronic media by other means will be subject to the discretion of the relevant authority.
As for devices, MOH Regulation 76/2013 allows marketing and advertising medical devices through information technology media. There is no elaboration in the regulation on the type of technology that may be used for such purpose. Yet, arguably, this may include the use of email, internet, social media and other information technology channels.
20. May drugs and devices be advertised or sold directly to consumers?
Please refer to our response to question 38 of Chapter 3 for the advertising of drugs and devices, also our response to question 39 of Chapter 3 for the sales of drugs and devices.
21. How is compliance monitored?
In general, the monitoring of compliance of drugs and medical devices is done by the MOH. In performing its monitoring duty, MOH appoints a supervisor to conduct inspection of the drugs and medical devices. If the inspection by the supervisor indicates any suspected violation, this will lead to an investigation by the authorized investigator in accordance with the prevailing regulations.
Specifically for drugs, certain monitoring duties are assigned to BPOM.
22. What are the potential penalties for noncompliance?
Any noncompliance with the requirements and provisions on drugs and medical devices under the prevailing regulations may subject the relevant party to: (i) administrative sanctions, in the form of written warnings, temporary suspension on distribution and/or order for product withdrawal, product extermination, and/or temporary/permanent revocation of licenses; and (ii) criminal penalties in accordance with the prevailing laws.