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ASEAN VARIATION GUIDELINE FOR PHARMACEUTICAL PRODUCTS Final Adopted Document JULY 2012LIST OF CONTENTS 1 2 3 3.1 3.2 4 5 6 7INTRODUCTION SCOPE OF THIS GUIDELINE DEFINITION Major Variation (MAV) Minor
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To fill out the www.hsagov.sg/docs/default-source/asean-variation-guideline-for document, follow these steps:
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Whether you are a business owner, an employee, a legal professional, or any individual dealing with ASEAN-related matters, referring to this guideline can help you navigate the variation process effectively.
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The wwwhsagovsgdocsdefault-sourceasean variation guideline provides a framework for the submission and evaluation of variations to registered products within ASEAN member countries.
Manufacturers and distributors of regulated products wishing to make changes to their registration or product specifications in ASEAN countries are required to file under this guideline.
To fill out the guideline, applicants must provide detailed information regarding the variation being proposed, including supporting documentation and evidence to justify the change.
The purpose of the guideline is to ensure that any variations to registered products are assessed for safety, efficacy, and quality, maintaining regulatory compliance across ASEAN countries.
The information required includes the type of variation, rationale for the change, detailed specifications of the product, and any relevant studies or data supporting the variation.
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