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GUIDELINE ON VARIATIONS FOR MEDICINESOCTOBER 15, 2019 NATIONAL MEDICINE REGULATORY AUTHORITY No.120, Norris Canal Rd, Colombo 01000, Sri LankaGUIDELINE ON VARIATIONS FOR MEDICINES CONTENTS 1. INTRODUCTION
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Start by reading the guideline on variations to understand its purpose and requirements.
02
Collect all necessary information about the variations you want to include.
03
Follow the format specified in the guideline for recording variations.
04
Clearly label each variation and provide detailed descriptions as needed.
05
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06
Review and proofread the completed guideline to ensure accuracy and clarity.
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Submit the filled out guideline to the appropriate authority for review and approval.

Who needs guideline on variations for?

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Anyone who wants to propose or implement variations to an existing process, product, or project can benefit from using the guideline on variations. This could include project managers, product developers, quality control teams, and regulatory bodies.
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The guideline on variations is a regulatory document that outlines the process for applying changes to an existing approval for a product, such as drugs or medical devices. It ensures that any modifications meet safety and efficacy standards.
Manufacturers or applicants of approved products are required to file a guideline on variations when they intend to make changes that impact the product's quality, safety, or efficacy.
To fill out the guideline on variations, the applicant must provide detailed information about the proposed changes, including the type of variation, supporting data, and any impact on product quality, safety, or efficacy. Specific forms and instructions will be provided by the regulatory authority.
The purpose of the guideline on variations is to ensure that any changes to approved products are thoroughly evaluated for compliance with safety and quality standards, thereby protecting public health.
The reported information must include the nature of the variation, the rationale for the change, detailed supporting data, and an assessment of any potential impact on the product's safety, efficacy, and quality.
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