Disapproval of Applications with Incomplete Documentary and/or Technical Requirements

Disapproval of Applications with Incomplete Documentary and/or Technical Requirements

In the interest of better public service and in line with the Food and Drug Administration’s (FDA’s) thrust for “Zero-Backlog”, the Center for Cosmetics Regulation and Research (CCRR) hereby advises all its stakeholders from the cosmetic, toys and childcare article (TCCA), household/urban pesticide (HUP) industries and other concerned parties that all applications received through the FDA e-Portal or through the FDA Action Center (FDAC) starting 01 October 2017 including but not limited to the following:

  1. Issuance of License to Operate (LTO), Certificate of Product Registration (CPR) and Product Notification (initial and renewal/revalidation);
  2. Re-issuance due to variations of License to Operate (LTO) and Certificate of Product Registration (CPR);
  3. Issuance of other authorizations, certificates, clearances and/or permits

with incomplete documentary and technical requirements shall be immediately DISAPPROVED

This is in accordance with the provisions of Book II Article I Section 4 “Grounds for Disapproval of Application and Suspension or Cancellation of License, Registration, or Authorization” of the Rules and Regulations Implementing Republic Act No. 9711, to wit,

“Any of the following or similar instances shall be a ground for the disapproval of an application, suspension, revocation or cancellation, of an existing LTO, CPR, or any authorization:

       A. License to Operate

  • The application requirements submitted show that the establishment does not meet the required technical requirements or appropriate standards;
  • xxx;
  • xxx;
  • Such other analogous grounds or causes as determined by the FDA.

      B. Authorization/Certificate of Product Registration.

  • The application requirements submitted show that the establishment does not meet the required technical requirements or appropriate standards;
  • xxx;
  • xxx;
  • xxx;
  • xxx;
  • Such other analogoues grounds or causes as determined by the FDA.”

All applications received prior to 01 October 2017 shall be processed according to the procedures in effect during that period and stakeholders who have received notices of deficiencies are advised to comply within the specified timeframe, otherwise their applications shall be disapproved once the grace period has lapsed.

This issuance shall serve as a notice to all stakeholders under the CCRR jurisdiction and shall be effective beginning 01 October 2017. Dissemination of the information to all concerned is requested.

Attachments:
Download this file (Draft for Comments.pdf)Draft for Comments.pdf

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