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To Facilitate the processing of applications under the “Project Backlog” of the Director-General, and to address the problem on the numerous “incomplete”, “unidentified  and “unmatched” applications lodged at the FDA electronic portal (e-portal) – Which were mixed with other completed applications, applicants with pending applications lodged at the FDA e-portal before February 1, 2018 (LTO, CPR and PN, as enumerated above), are advised to confirm their application by filling-up the details required in this link: http://bit.ly/fda_zero_backlog

Last day of confirmation of the covered applications (to be included in the Project Backlog) will be on 25 August 2018 (Saturday), at 11:59 o’clock in the evening.

Applications for authorizations lodged at the FDA e-portal before 1 February 2018, which are not confirmed by 25 August 2018, shall be processed accordingly once confirmed. Confirmation shall only be accepted until 31 December 2018. Thereafter, all unconfirmed applications shall be deemed abandoned.

Submission of falsified, fictitious, misleading and/or fake requirements (information or document) shall be a ground for the immediate disapproval and revocation of the application for authorization/s secure a forfeiture of any fees paid, without prejudice to the filling of the appropriate criminal, civil and administrative charges against the erring QPIRA and/or the applicant for authorization.

Queries and clarifications may be sent to [email protected]

For your information, guidance and compliance.

FDA Advisory No. 2018-241