Sales Promotion
• Legal Bases
• Application Procedure and Requirements
• What is Required from companies?
PRESENTATION OUTLINE
Article 108. Declaration Policy –
The State shall protect the consumer from misleading
advertisement and fraudulent sales and promotion
practices.
Article 109. Implementing Agency –
The Department of Trade and Industry shall enforce the
provisions of this Chapter and its implementing rules and
regulations: Provided, That with respect to food, drugs,
cosmetic, devices and hazardous substances, it shall be
enforced by the Department of Health.
RA 7394
The Consumer Act of the Philippines
No person shall conduct any sales campaigns, including beauty
contest, national in character, sponsored and promoted by
manufacturing enterprises without first securing a permit from
the concerned department at least thirty (30) calendar days
prior to the commencement thereof. Unless an objection or
denial is received within fifteen (15) days from the filing of the
application, the same shall be deemed approved and the
promotion campaign or activity may be conducted: Provided,
That any sales promotion campaign using medical prescriptions
or any part thereof or attachment thereto for raffles or a
promise of a reward shall not be allowed, nor a permit to be
issued thereof.
Promotion of Sales of Consumer Products and Services
Article 116. Permit to Conduct Promotion (RA 7394 )
4
Sec. 1. General Provisions
a. The manufacture, importation, exportation, sale,
offering for sale, distribution, transfer, non-
consumer use, promotion, advertising, or
sponsorship of any health product without the
proper authorization from the FDA is
prohibited.
BOOK II IRR 9711
ARTICLE I
Licensing of Establishments and Registration
of Health Products 5
Sec.2. General Rules in Advertisements, Promotions,
Sponsorship, and Other Marketing Activities of any Health
Product
No health product that has not been registered or
authorized shall be advertised , promoted or subjected to any
marketing activities.
No claim in the advertisement, promotion and sponsorship,
other marketing activities shall be made other than those
contained in the approved label or packaging of the health
product, or as duly approved by FDA.
BOOK II IRR 9711
ARTICLE V
Advertisements, Promotions, Sponsorship,
and Other Marketing Activities
6
No claims, therapeutic or scientific
otherwise, shall be made that has not
been duly approved by the FDA
All health products that are permitted to
be promoted must specifically state the
authority or reference number that
approved the same promotional,
sponsorship, or marketing activities.
BOOK II IRR 9711
ARTICLE V
Advertisements, Promotions, Sponsorship,
and Other Marketing Activities
7
Section 2.3
No pharmaceutical product classified by BFAD as
a prescription or Ethical Drug shall be advertised
or promoted in any form of mass media except
through medical journals, publications and/or
literature solely intended for medical and allied
professions.
AO 65 s. 1989
Guidelines on Advertisements and
Promotions to Implement the Generics Act of
1988
8
Section 3.2
The pertinent provisions of AO 55 s. 1988 on
Requirements for Labelling Materials of
Pharmaceutical Products quoted hereunder shall
apply with the exception that the world “label”
will be substituted by “advertising and other
promotional material”.
AO 65 s. 1989
Guidelines on Advertisements and
Promotions to Implement the Generics Act of
1988
9
FDA Memo Circular 2013-025
Transfer of Advertisement and Promotion Functions
from the Legal Services Support Center to the other
Centers of FDA
Starting 13 July 2013 all applications for sales
promotion permits, requests for clearance of
advertisements of health products including activities
attendant thereto and approval thereof will be
received and processed in the respective FDA Center
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General Guidelines on the Promo Permit
Applications and for other Purposes
• Filing of Application for Sales Promotion Permit
At least 30 days before the actual commencement
• Invitation for Supervision/Attestation
7 working days before actual activity
FDA Memo Circular 2013-028
11
• Application with combined products of
different categories:
Drugs, Food, Cosmetics, Device and HHS -
CDRR
Food, Cosmetics, Device and HHS –
CDRRHR
Food, Cosmetics and HHS – CFRR
Cosmetics and HHS - CCRR
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• Letter of Request
• Accomplished Mechanics and Info Sheet
• Accomplished IAP
• List and Copy of CPRs of Participating Products
• Media/Collateral Material, if any
• Proof of Payment
Requirements
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• Apply ahead of time
• Submit complete and correct set of requirements
• Promo activity will only commence with issuance of Permit
• Duly follow all provisions under Initial/Amendment Permit
• Any changes to prior authorization must be filed as
amendment
• Advertisement permits are filed thru ASC
What is required on your end?
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