FDA Advisory No. 2020-2035
Date Activity Remarks
30 October 2020 Launch of the HUHS e-Portal System*
*link to request for User Account Acceptance of requests for User Account and processing of requests thereafter
2-13 November 2020 Uploading of User’s Guide/video tutorial on the use of HUHS e-Portal in the FDA website Cascading materials for reference of stakeholders
16 November 2020 Launch of the Licensing Application Form in the HUHS e-Portal Acceptance of licensing applications and processing of applications thereafter
1 February 2021 Launch of the Registration Application Form in the HUHS e-Portal Acceptance of product registration applications and processing of applications thereafter
*Full compliance to the new labeling requirements shall be made mandatory upon renewal of the product registration.
All previous applications and requests that are not in accordance with the above timelines shall not be processed.
For HUHS Manufacturers, all applications shall be processed accordingly. However, due to existing community quarantine, site inspection shall be done as a post-licensing activity and subject to local quarantine conditions.
In view of the foregoing, all covered establishments are advised to comply with the provisions of FDA Circular No. 2020-0025, subject to the above implementation timelines, and to adhere to standards in ensuring the safety, quality and efficacy of all HUHS products at all times.
This Office shall no longer issue any other certifications or documentation to individual establishment or company to further clarify the provisions of FDA Circular No. 2020-0025.
This advisory shall take effect immediately and shall be subject to post-implementation review as may be necessary.
For information and guidance. Dissemination of this advisory to all concerned is hereby requested.
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Post from Food and Drug Administration Philippines
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