Veterinary Medicines Registration in Indonesia
Contents Overview
Categories of Veterinary Product Registrations in Indonesia
- Biological Preparations: Produced through biological processes in animals or animal net to boost immunity, diagnose, or cure diseases using immunologic methods.
- Pharmaceutical Preparations: Includes vitamins, hormones, antibiotics, and other chemotherapeutic medicines, such as antihistamines, antipyretics, and anesthetics.
- Premix Preparations: Additives mixed into animal food or drinks, including animal food supplements designed to enhance nutrition.
- Natural Medicines: Derived from natural sources to prevent or treat health issues in animals, typically using herbal or plant-based ingredients.
The regulatory body overseeing these products is the Ministry of Agriculture of the Republic of Indonesia, specifically the Directorate General of Livestock and Animal Health Services (DGLAHS). Applicants must obtain a Veterinary Drug Business License through the Online Single Submission (OSS) system by submitting the necessary documents and company information on the DGLAHS platform.
Estimated costs for drug registration in Indonesia are as follows:- Pre-registration Fees: $65-$70 (IDR 1,000,000 per item)
- Registration of New Active Substances or Biological Products: $1,900-$2,000(IDR 30,000,000 per item)
- New Indications or Dosage Forms for Existing Products: $1,300-$1,400(IDR 20,000,000 per item)
- Generic Drugs with Generic Names: $130-$140 (IDR 2,000,000 per item)
SIMPLIFY REGISTRATION
General Requirements for Veterinary Product Registration in Indonesia
The veterinary product registration process in Indonesia ensures that imported treatments meet the highest standards. In Indonesia, registering veterinary products involves adhering to the regulations established by the Ministry of Agriculture under Government Regulation No. 78/1992.
Local agents (distributors) and manufacturers must collaborate effectively to meet specific regulatory needs. Below is an overview of the typical steps and documents required for both manufacturing site and product registration.
STREAMLINE REGISTRATION
Steps for Manufacturing Site Registration
Submission of Application Forms
Applicants must submit completed forms, supporting documents, and technical data. The manufacturer/importer must have a veterinary drug business license from Indonesia’s Ministry of Agriculture. An appointment letter from the origin manufacturer confirming sole agent status is required, and the product must not be registered by another applicant.
GMP Certification
Proof that the manufacturing site complies with Good Manufacturing Practices. In Indonesia, the local GMP is called CPOHB (Cara Pembuatan Obat Hewan Yang Baik). All local manufacturers must have CPOHB certificates for all their products. MNCs (Multi-National Corporations) and importers need to provide GMP certificates from the manufacturing sites and must submit it to the authority bodies.
Document Authentication
Legalization or notarization of foreign-issued documents. This step is crucial in order to ensure the validity of the documents under Indonesian law. This step might also require a certified translator to translate into Bahasa Indonesia, but both the original and translated copies must be submitted.
Submission of Technical Documents
Such as the Site Master File (SMF) and facility details. This step simplifies the operational procedures for registration.
Site Inspection
Regulatory authorities may conduct inspections to verify compliance with local standards. Indonesian regulatory authorities may perform on-site inspections to confirm compliance with operational requirements.
Estimated Timeline: The estimated timeline for the process is 3-6 months, depending on factors such as the complexity of the process, the responsiveness of the applicant, and the efficiency of the authorities. Document preparation typically takes 1-3 months, while the GMP review and site inspection can range from 2 to 6 months.
FAST-TRACK REGISTRATION
Steps for Product Registration
Dossier Submission
Submitting a dossier in Indonesia can be challenging due to inconsistent assessments, lack of a standard checklist, and limited regulatory knowledge. While improvements have been made with an online system and ASOHI’s collaboration with the government, these issues still create obstacles.
Certificate Submission
Free Sale Certificates (FSCs) verify that a product is approved for sale in the country of origin. If a product is not sold in the origin country, companies must submit two FSCs from countries where the product is marketed, with one from a developed country (e.g., EU/US) for innovative products. Certificates of Pharmaceutical Products (COPPs) are issued under WHO guidelines for pharmaceutical registrations and may need to be notarized by the Indonesian Embassy in the country of origin. There are generally no major concerns regarding GMP and FSC.
Product Labeling and Packaging Compliance
In Indonesia, labels must include Bahasa Indonesia for product instructions, ingredients, and warnings, and all statements must align with approved therapeutic claims. Key information like the importer, expiry date, batch number, and controls must also be included. Regulatory inspections at warehouses ensure all requirements are met, though companies rarely face issues with labeling or inspections.
Sample Submission and Testing
Laboratory verification of product quality and efficacy. The Directorate General of Livestock and Animal Health Services in Indonesia is responsible for giving recommendations for acceptance of veterinary medicine registration. It conducts testing in the National Veterinary Drug Assay Laboratory (NVDAL) of veterinary medicine quality.
Approval and Registration Certificate Issuance
Once approved, distributors can import and sell the product. If the testing is successful, then distributors get veterinary medicine product certificates and after that can sell the product.
The process typically takes 6-12 months, depending on dossier completeness and testing requirements. Dossier submission and review vary: Path I takes 100 days, Path II takes 150 days, and Path III takes 300 days for new drugs or 80 days for others. Sample testing and approval usually takes 1-3 months. Delays may occur due to missing documentation, failed tests, or additional inquiries.
Key Considerations for Success
- Prepare a Detailed Dossier: Include all necessary documents as per Indonesian regulatory guidelines.
- Check for Errors: Double-check for inconsistencies, missing information, or errors in technical documents like the Site Master File (SMF) and Certificates of Analysis (COA).
- Verify Document Requirements: Identify which documents require notarization or legalization under Indonesian law.
- Adhere to Submission Deadlines: Follow the prescribed timelines, as delays can extend the approval process.
Strong Distributor Partnerships. To be successful in this industry, you need to select distributors with proven experience in the Indonesian veterinary market who are familiar with the registration process. Collaborate with reliable local agents and establish clear communication to streamline tasks like document submission, translation, and product sample handling and testing.
Your tasks also include following the local post-registration requirements, so you need to find good partners that can handle the storage, transport, and labeling standards.
Experienced Manufacturing Partner. Work with manufacturers who understand regional requirements and follow the GMP standards according to the Indonesian regulatory needs. Ensure the manufacturer has a dedicated regulatory affairs team to provide documentation support and solve potential queries from local authorities.
Simplifying the Registration Process with AdvaCare Pharma
Going through the complex process of registering foreign veterinary products in Indonesia requires a deep understanding of each country’s specific regulations, from dossier submission to local testing and post-market surveillance. Partnering with an experienced company like AdvaCare Pharma, which has extensive expertise in the region, ensures a smoother and more efficient registration process. With our insights and tailored services, we help you overcome regulatory challenges and successfully register your veterinary products in Indonesia.
It is important for distributors to work with manufacturers that are able to provide utmost technical support in this highly complex process.
How Do We Make Registrations Easier?
- Streamlined Document Preparation and Authentication AdvaCare Pharma ensures that all site documents, including the Site Master File (SMF) and GMP certificates, are constantly up-to-date and ready for submission. This allows for a fast start in the site registration process. We prioritize the authentication process and, with the distributor's confirmation, make sure that the correct documents are legalized right away, minimizing delays and avoiding unnecessary costs due to the wrong documents being processed.
- Experienced in GMP Review and Site Inspections AdvaCare Pharma has successfully passed multiple GMP reviews and site inspections across the region, meeting the high standards expected by local authorities. Our production facilities maintain stringent quality control measures, ensuring compliance with regulatory requirements. From facilitating visa applications to guiding inspectors during site visits, AdvaCare Pharma efficiently manages the entire inspection process, providing a seamless experience for distributors and inspectors alike.
- Comprehensive and High-Quality Dossier Submission At AdvaCare Pharma, we prioritize quality and compliance in every dossier submission. Our experienced technical team ensures that each dossier is tailored to meet the specific requirements of the country where the registration is being filed. By thoroughly gathering all necessary internal and external references before starting the registration process, we minimize the chances of additional requests or rejections from local authorities, making the review process smoother and faster.
- Custom Packaging and Sample Quality Packaging is a critical element in product registration, and AdvaCare Pharma goes the extra mile to ensure it meets local standards. We collaborate closely with our distributors to design and produce packaging artwork that complies with local regulations. Our samples are manufactured according to registration requirements to ensure the highest quality, which aligns with each country’s stringent testing and evaluation requirements. This approach guarantees that our products meet all local standards, facilitating a successful and efficient registration process.
AdvaCare Pharma understands the complexities of navigating the rigorous registration requirements for veterinary products. With several products already registered in the ASEAN region and 40+ countries worldwide, we provide a streamlined and reliable path to market success. Our commitment to regulatory excellence, combined with tailored support and packaging solutions, ensures that your registration process is smooth and efficient.
Join our global network of trusted distributors today. As an AdvaCare Pharma partner, distributors will benefit from comprehensive regulatory and technical assistance, ensuring faster market access for high-quality, affordable products. We also offer exclusive distributor perks, including comprehensive marketing support, product training, and sales resources to help grow your business. With a commitment to strong partnerships, we are dedicated to your long-term success. Visit our website and apply for distributorship to gain a competitive edge in your region.
References: Indonesian Legislation Translations 1992 “GOVERNMENT REGULATION OF THE REPUBLIC OF INDONESIA No. 78/1992” USFDA Foreign Agricultural Service 2019 “Registration Guide for Feed Additives”
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