ASC Circular 2017-014 – CPRs/CPNs

ARTICLE 112 of the Consumer Act of the Philippines (R.A. 7394) on Special Advertising Requirements for Food, Drug, Cosmetic, Device or Hazardous Substance, letter f) states that: “No person shall advertise any food, drug, cosmetic, device, or hazardous substance unless such product is duly registered and approved by the concerned department for such use in any advertisement.”

In line with this, the ASC would like to remind everyone that S1 ad applications of food, drugs, and medical devices should have an attached Certificate of Product Registration (CPR), while those of cosmetic products should have an attached Certificate of Product Notification (CPN). Applications without CPR/CPN will be automatically DISAPPROVED.

For new products awaiting release of their CPR/CPN and for existing products with expiring/expired CPR/CPN, which have filed for CPR/CPN renewal, and which do not have any product change/reformulation, ASC needs the following documents as support:

    1. Photocopy of the tracking log
    2. Photocopy of the FDA official receipt of payment of the renewal fee
    3. Expiring/expired CPR/CPN (in the case of existing products)

Your S1 application will be given an INCOMPLETE decision (assuming all copy claims, if any, are fully substantiated and other requirements are complete) and you have until 4PM of the tenth (10th) calendar day from the date of application to submit the CPR/CPN. Failure to do so will render your application automatically DISAPPROVED. (As per July 1, 2016 Updated ASC Guidebook).

Once CPR/CPN is issued, you can reapply for S1.

For strict compliance.

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