Form RegA2: Application Form for Section S Revision for Products (Anti-Infectives) Registered Before the Implementation of Directive on Regulatory Control of API
1. Only applicable for registered products containing Anti-Infectives with the expiration of the registration period starting 1 January 2020.
2. Please make sure that the product is not having any pending status (e.g. variation/ save form/ additional indication/ COS/COH etc.).
3. Application shall be made 12 - 15 months before the end of the expiration of the product registration. Any application other than the indicated period will not be entertained.
4. Once "Section S Revision" function is enable in QUEST 3+ system, applicants have a limited timeframe of 30 calendar days to complete the updates for Part II S.
5. Each application form is indicated for one product (with one MAL number only).
6. This application form is effective starting 16 Dec 2019.
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