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What You Need to Know About Variations to Therapeutic Product Licences in Singapore


Navigating the complexities of therapeutic product licences in Singapore is important for pharmaceutical and medical device businesses to maintain regulatory compliance. When there are changes to a product’s safety, efficacy, quality, or forensic classification changes after registration of the pharmaceutical products, understanding the process and requirements for licence variations becomes crucial. This guide offers an overview of variation types, the submission process, necessary documentation, regulatory requirements, and the importance of post-approval monitoring.

Types of Variations

Post-approval variations to therapeutic product licences in Singapore are classified as either major or minor. Major variations involve significant changes to the approved indication, route of administration, dosing regimen, intended use, or forensic classification, and require a thorough review by the Health Sciences Authority (HSA), potentially including additional clinical data. On the other hand, minor variations entail less significant changes, such as updates to labelling or packaging , change in address of the manufacturer, submission of CEP in replacement of DMF, etc.  While less complex, they still require careful assessment against what was previously approved and submitted  to ensure compliance with regulatory standards.

Variation Submission Process

Submitting a variation application to the HSA follows a systematic process. Begin by determining the type based on the proposed changes. Follow the appropriate checklist and prepare the documentation appropriate to the category of the MIV.  The last step is to apply through HSA’s online portal, PRISM. Make sure that all the necessary information is complete and accurate to avoid delays. HSA will review the submission and may request additional information if needed. Upon review completion, input requests will be issued if there are any questions, if not you will receive an email notification to inform you of the status of the variation. Do note that for minor variation, only one minor variation can be submitted at all times. Certain minor variations don’t require prior approval, but the application must be submitted within six months of the changes. Additionally, the HSA provides a self-guided tool to assist with minor variation applications. ​​For further details, please visit HSA’s website.

Licence Variation Documentation

The documentation required for licence variations depends on the proposed change type. Major variations typically require detailed information, including new clinical data, revised product specifications, and updated risk assessments. Conversely, minor variations generally need less extensive documentation, such as updated labels or packaging inserts. Providing comprehensive and accurate documentation is vital to meet regulatory expectations and facilitate a smooth approval process.

Singapore Regulatory Guidelines

The regulatory guidelines for variation of therapeutic product licences in Singapore are designed to maintain the safety and efficacy of medical products. HSA mandates adherence to specific guidelines regarding the changes that require approval and the documentation for each type. Familiarity with these guidelines helps streamline the submission process and supports successful pharma market access by ensuring that all regulatory requirements are fulfilled, thereby reducing the risk of non-compliance.

Post-Approval Monitoring

Finally, post-approval monitoring is crucial to upholding the safety and efficacy of therapeutic products. Ongoing surveillance and reporting are necessary to track the product’s performance in the market after a variation is approved. This includes monitoring for any adverse effects or issues that may arise and promptly reporting them to the HSA. Effective post-approval monitoring helps verify that the product continues to meet regulatory standards and remains safe for use.

Managing changes to therapeutic product licences in Singapore is key to staying compliant with regulations. Understanding these factors will help you avoid common pitfalls and ensure that your products remain compliant throughout their lifecycle. 

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For expert guidance and comprehensive support with therapeutic product licences in Singapore, our team at The Reg Consultants is always ready to help. We are well-versed in licence variations, submission processes, and regulatory compliance. Discover how our pharma regulatory services can ensure your products meet all necessary standards and maintain their market readiness. 

For companies that already have a mature product pipeline which requires maintenance activities, do check our advance subscription plan for more information. 

Visit our website today and let us help you achieve seamless regulatory compliance.

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If you have any specific regulatory questions pertaining to entering the Singapore market or require assistance with pharma regulatory services and medical product registration, feel free to reach out. Your success in the pharmaceutical industry starts with us!

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