The Food and Drug Administration (FDA) has published a draft circular for comments outlining the proposed Operational Procedures and Requirements for the Application of a Sales Promotion Permit for FDA-regulated health products. The draft aims to establish a streamlined and harmonized application process for sales promotion campaigns and is currently open for public comment.
Read the full announcement to learn more:
https://www.fda.gov.ph/draft-for-comments-operational-procedures-on-the-application-for-sales-promotion-permit-with-the-food-and-drug-administration/
Read Annex A and Annex B to the draft circular for details:
ANNEX A_SPP_eServices_Initial [PDF link]
ANNEX B_SPP_eServices_Variation [PDF link]
Purpose of the Draft Circular
- To define the operational procedures and documentary requirements for securing a Sales Promotion Permit for FDA-regulated health products.
- To standardize and harmonize the application process for promotional activities across regulated establishments.
- To ensure that all sales promotion campaigns involving health products comply with applicable Philippine laws and FDA regulations.
Key Highlights
Who Must Apply
- Manufacturers
- Distributors (Importers, Exporters, Wholesalers)
- Retailers and Pharmaceutical Outlets
All establishments conducting sales promotion campaigns involving FDA-regulated products in the Philippines are required to secure a Sales Promotion Permit.
What Constitutes a Sales Promotion
Sales promotion campaigns include activities that:
- Contain promises of gain (e.g., prizes, rewards in cash or in kind) offered as an incentive tied to the purchase of a product, security, service, or participation.
- Involve contests, raffles, games, tournaments, or similar competitions, including those promoted through mass media or other widespread communication channels.
- Employ techniques intended to increase sales, patronage, and/or goodwill of a product.
General Guidelines
- All health products intended for sales promotion must be registered with or authorized by the FDA.
- Establishments, including those utilizing online platforms, must secure a Sales Promotion Permit at least thirty (30) calendar days prior to the start of the promotion period.
- All promotional materials (advertisements, publications, announcements) must clearly state the authority or reference number approving the activity using the format:
“Per DOH-FDA-(Center/Region) Permit No. xxxx s. xxxx.”
- An invitation or notice for FDA supervision or attestation of an approved sales promotion must be submitted more than seven (7) days prior to the scheduled event.
- For activities such as printing, seeding, and/or drawing of winners conducted outside the Philippines, notification must be submitted at least thirty (30) calendar days in advance to allow the FDA to prepare the necessary travel documentation.
Application Requirements and Procedure
- Applications must be filed online via the FDA eServices Portal System prior to the start date of the promotional campaign.
- The following documents are required:
- Duly accomplished online application form
- List of participating products
- Mechanics of the sales promotion
- Copy of valid product registration certificates
- Proof of payment of application fee
- The FDA will conduct a pre-assessment to determine completeness of submissions.
- Complete applications will be issued an Order of Payment.
- Incomplete applications will receive a Notice of Deficiency and must be re-filed as a new application with complete documentation.
- Approved Sales Promotion Permits will be:
- Sent to the official email address of the applicant; and
- Accessible through the FDA eServices Portal System.
Voluntary Cancellation of Approved Sales Promotion Campaigns
- Establishments may voluntarily cancel an approved sales promotion before publication, or after publication but before the promotion period, subject to applicable FDA guidelines.
- Cancellation, discontinuance, or suspension of an on-going promotion is not allowed without FDA approval.
- FDA approval for cancellation of an on-going promotion may only be granted under the following circumstances:
- A final judgment of insolvency issued by a court of competent jurisdiction; or
- Fortuitous events that render continuation of the promotion impossible.
- Winners determined prior to FDA approval of cancellation must still be awarded their prizes.
Public Comment Period
- Open until: 12 January 2026
- Comments must be submitted using the prescribed “Template for Comments” doc
- Submission format: MS Word and PDF
- Submission email: pps@fda.gov.ph
Implications to Clients
Manufacturers, distributors (importers, exporters, wholesalers), and retailers planning to conduct sales promotion campaigns involving FDA-regulated health products must ensure that all participating products are duly registered or authorized and that a Sales Promotion Permit is secured from the FDA at least 30 calendar days prior to campaign launch, including promotions conducted via online platforms.
As the draft circular remains open for comments until 12 January 2026, stakeholders are encouraged to review the proposed procedures and consider submitting feedback should the requirements impact their promotional timelines or marketing strategies.
For inquiries or support regarding medical device regulatory requirements in the Philippines, please contact sales@andamanmed.com.
