Republic of the Philippines Department of Health BUREAU OF FOOD AND DRUGS ‘Alabang, Muntinlupa December 8, 1987 BFAD REGULATION No. 5s. 1987 SUBJECT: GUIDELINES ON ADVERTISEMENT AND PROMOTIONS OF PRESCRIPTION PHARMACEUTICAL PRODUCTS, WHEREAS, It Is the policy of the state as enunciated in Article 11, Section 15 of the 1987 Constitution "to protect and promote the right to health of the people and instil health consciousness among them;" WHEREAS, Section 3 (c) of R.A. 3720, as amended by Executive Order No. 175 cothewise known as the "Foods, Drugs and Devices, and Cosmetics Act" mandated the Government, through the Department of Health to implement the fore-going policy by adopting measures to ensure the rational use of drugs; WHEREAS, itis a part of the national drug policy to provide adequate and accurate information for the rational use of drugs. WHEREAS, Section 4 of Executive Order No. 851 dated December 2, 1982 and Section 13 (b) of Executive Order No. 119 dated January 30, 1987 mandated the Bureau of Food and Drugs (BFAD) to prescribe general standards and guidelines with respect to the veracity of nutritional and medicinal claims in the advertisement of drugs in the various media and to monitor such advertisements; NOW THEREFORE, upon recommendation of the Director of the Bureau of Food and Drugs, the following guidelines on the advertisement and promotions of prescription pharmaceutical products for man are hereby promulgated for the information, guidance and compliance of all concerned. Section 1. As used in this Regulation, the term: a. "Advertisement" includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any pharmaceutical product. b. "Promotion" means the practice of giving temporary additional valueto a brand, product, or service to achieve specific marketing objectives. "Promotion" includes the distribution of free/sample pharmaceutical products. 435c. "Pharmaceutical Product" means any pharmaceutical or biological product intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man orto affect the structure or any function of the body of man. d. “Prescription Drugs" are pharmaceutical products or drug preparations that are to be dispensed only upon written order of a duly licensed physician or dentist for the management or treatment of a condition or a diagnosed disease of man. They are also known as “Ethical Drugs". @. "Mass Media" means any publication, book, notice, handbill, poster, circular, pamphlet, letter, billboard, print media, radio, television, cinema, mobile audio visual units or any other widespread medium of information directed to the lay public. Section 2. No person shall advertise or promote prescription drugs unless such product Is duly registered by the BFAD. Section 3. No pharmaceutical product classified by the BFAD as a prescription 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. Section 4. Press releases, editorials, health Columns and features and public service announcements on health and medicines shall not specify brand/trade names. Generic names are, however, permissible. For prescription drugs, it should be clearly stated that this product can be bought only with a prescription and doctor's advise shall be sought. Section 5. Any change in product presentation, such as change in packaging, of a prescription drug may be advertised for public information, provided no medical claims, comparative statements, or promotional messages are included in the announcement; provided further that the following statement is always clearly indicated: ‘This pharmaceutical drug product is approved for sale by BFAD as a prescription drug and should be bought only with a prescription." Section 6. The giving of sample of a prescription drug direct to the lay publics strictly prohibited. The distribution of free/sample pharmaceutical products during medical missions and within outpatient dispensaries is not considered a violation of this provision, provided that the distribution is under the supervision of a physician. Section 7. For prescription drugs, raffles, gifts, promises of reward or any form of inducement to the prescribers is prohibited. Section 8. Any person who violates the provision of this regualtion shall be dealt with administratively, by the BFAD, after notice and summary hearing conducted by its Legal Division. Any or all the following administrative sanctions may be imposed by BFAD. 1. Issuance of cease and desist Order. 2. Cancellation of the Certificate of Product Registration and withdrawal of the product from the market within forthy five (45) days from date of cancellation. 3. Imposition of adminisitrative fines in the amount of five thousand (P5,000.00) Pesos.The imposition of the administrative sanctions Is without prejudice to the filing of a separate criminal action as may be allowed under existing laws. Section 9. This regulation shall take effect immediately after publication in at least ‘two (2) newspapers of general circulation or in the Official Gazette. (Sgd.) CATALINA C. SANCHEZ Director APPROVED: (Sgd.) ALFREDO R. A. BENGZON, M.D. Secretary of Health