Veterinary Medicine Licensing: Step-by-Step Guide

A veterinary business license is essential and not just a formality. It is a key legal requirement for anyone working in the veterinary medicine industry in Indonesia. Proper regulation ensures that animal health products are safe, effective, and high-quality. Companies can face severe penalties, shutdowns, or product bans without these regulations. 

Overview of Veterinary Business Licensing 

The Indonesian government enforces strict controls on veterinary medicine to protect public and animal health. The Ministry of Agriculture (MoA) oversees licensing and registration in the veterinary sector to ensure that only authorized businesses operate.  

Any company importing, producing, or distributing veterinary medicine must obtain official approval. Government Regulation No. 26 of 2021 provides the main rules for getting a license for veterinary medicine.  

All animal medicines must obtain an Animal Medicine Registration Number from the Ministry of Agriculture. 

• Biological veterinary medicine (e.g., vaccines) 
• Pharmaceutical, veterinary medicine (e.g., antibiotics) 
• Premix veterinary medicine (e.g., feed additives) 
• Natural animal medicine 

Who Needs a Veterinary Business License? 

A veterinary business must obtain a veterinary business license to operate legally. This license is essential for ensuring compliance with local regulations and maintaining professional standards in animal care. 

• Veterinary clinics offering animal health services 
• Veterinary medicine importers and distributors 
• Animal health product manufacturers 
• Animal medicine storage and distribution businesses 

Participating in veterinary medicine’s sales, importation, or manufacturing requires a specific license. Engaging in these activities without the necessary authorization is considered illegal. 

Veterinary Business License Requirements in Indonesia 

A veterinary business in Indonesia must fulfill specific legal, technical, and operational requirements before receiving approval. These requirements ensure that veterinary clinics, medicine manufacturers, and distributors operate ethically and safely. To apply for a veterinary business license, companies must submit: 

• Business Identification Number (NIB) with the Appropriate KBLI Code: The business must be classified under KBLI codes that align with veterinary medicine regulations. 
• Technical Responsible Person (PJT – Penanggung Jawab Teknis): A qualified veterinarian or pharmacist who has completed certified training in veterinary medicine safety. 
• Standard Operating Procedures (SOPs): Detailed SOPs for handling, storing, and distributing veterinary medicine. 
• Organizational Structure: A company chart highlighting the roles and responsibilities related to veterinary medicine operations. 
• Animal Medicine Dossier: A comprehensive technical document detailing veterinary medicine’s composition, efficacy, and safety. 
• Facility Feasibility Assessment: An on-site inspection to evaluate compliance with veterinary medicine storage and safety protocols. 

How Long Does It Take to Get a Veterinary Business License? 

Obtaining a veterinary business license generally requires 1 to 2 years. This duration can vary based on factors such as preparing necessary documents, completing inspections, and completing the approval process. 

Steps to Obtain a Veterinary Business License in Indonesia

Here’s a step-by-step guide to obtaining a veterinary business license in Indonesia. The process involves submitting the necessary documents, undergoing facility inspections, and receiving regulatory approvals. 

• Document Submission: Prepare and submit the required paperwork, including the license application, veterinary medicine dossier, and SOPs. 
• Application Processing: The Ministry of Agriculture reviews the submission through the Online Single Submission (OSS) System. 
• Facility Inspection: Government inspectors will evaluate the facility to ensure compliance with GDP and GMP standards. 
• Corrective and Preventive Action (If Needed): Businesses must make necessary improvements if deficiencies are found. 
• License Issuance: The veterinary business license is granted once all requirements are met. 

READ MORE:

• How to Easily Access The OSS Login System in Indonesia 
• Securing an Import License via OSS in Indonesia 
• Online Single Submission System (OSS) and Business Identification Number (NIB) in Indonesia

Veterinary Medicine Registration Process in Indonesia 

All veterinary medicine intended for sale, distribution, or use in veterinary clinics must be officially registered with the Ministry of Agriculture to ensure compliance with Indonesian veterinary medicine safety standards. 

• Document Preparation: Submit all technical documents for the medicine. 
• Government Review: The Ministry of Agriculture assesses the validity and completeness of the application. 
• Registration Submission: The business applies to the OSS system. 
• Facility Inspection (If Required): Some products require on-site manufacturing inspections. 
• Final Approval: The medicine receives a registration number, allowing legal distribution in Indonesia. 

Common Challenges in Obtaining a Veterinary Business License 

Getting a veterinary business license in Indonesia can be difficult. This is due to strict rules, long approval times, and frequent policy changes. 

Many businesses experience delays, rejections, or compliance problems. Understanding and preparing for these challenges is important to ensure a successful application. 

• Lengthy Processing Time: Licensing can take 1–2 years due to government reviews.  
• Strict Facility Standards: Companies must comply with GDP and GMP requirements.  
• Regulatory Changes: Frequent updates to veterinary laws require businesses to stay informed. 

Getting a veterinary business license in Indonesia can be complicated. An expert consultant, like InCorp, can help make the process easier. Our knowledge and experience can help you quickly navigate the licensing and registration procedures. 

Get Your Veterinary Business Licensing with InCorp 

Getting a veterinary business license and registering for veterinary medicine in Indonesia is complicated. It involves strict government rules, detailed paperwork, facility inspections, and technical standards. Without proper guidance, businesses often face delays, rejections, and additional costs. 

At InCorp Indonesia, part of Ascentium Company, we help businesses with the veterinary licensing and registration process. Our goal is to make this process easier and faster for you. Here’s why partnering with us is the best choice: 

• End-to-end Licensing Support: We handle everything from document preparation to application submission and final license collection. 
• Expert Regulatory Consultants: Our experienced team stays updated on the latest Ministry of Agriculture regulations to ensure your compliance. 
• Faster Approval Process: With our industry expertise, we help businesses avoid common pitfalls that cause delays. 
• Hassle-Free Government Liaison: We coordinate with the Ministry of Agriculture and other authorities, so you don’t have to. 
• Customized Solutions: Whether you are a veterinary clinic, importer, distributor, or manufacturer, we tailor our services to meet your needs. 

Fill out the form below for expert assistance with your veterinary business license and medicine registration in Indonesia.