FDA Rules on Sales Promotion Permit

Food and Drug Administration (FDA) issued the current guidelines on sales promotion permit applications last July 5, 2013. Under FDA Memorandum Circular no. 2013-028, applicants are required to file their application for permit at least thirty (30) days before actual commencement of the sales promotion. 

This timeline is pursuant to Article 116 of R.A 7394 otherwise known as "The Consumer Act of the Philippines".The Circular further informs concerned establishments e.g health products, advertising/promotional agencies and other parties concerned, to strictly observe said provision starting August 5, 2013.

Rules on applications

The applications concerning the following products are to be submitted to the respective FDA Centers, as follows:
1) Drugs, foods,cosmetics, HHS (or Drugs with any product categories)- to Center for Drug Regulation and Research. 2)Food, cosmetic, device, HHS (or Device with any product categories excluding Drugs)-to Center for Device Regulation, Radiation Health and Research, 3) Food, cosmetic, HHS- to Center for Food Regulation and Research, and 4) Cosmetics and HHS-to Center for Cosmetic Regulation and Research.

Applications falling short of the required timeline for filing shall no longer be accepted unless the applicant signifies his intention to comply. The processing time is within ten (10) working days upon receipt of the application. Follow-ups shall be allowed only after the processing time.

Rules on approved permits

When inviting for FDA supervision/attestation for approved sales promotion permit, the notice or written invitation should be submitted to the DOH-FDA regional office concerned not less than 7 days before the event. Otherwise, the promotional activity shall be considered for automatic re-scheduling, the week after the notice was received. No short notice shall be entertained.

For activities requiring the presence of authorized DOH-FDA representative on a weekly, bi-weekly, and monthly basis, a single written invitation will suffice, provided that any change in the approved permit shall be properly coordinated with FDA.

To give ample time for DOH-FDA representative for activities such as printing, seeding, and/or drawing of winners to be held outside the country, notification must be made at least thirty (30) calendar days before the event.