Republic Act No. 3720 Quiz

Center for Device Regulation, Radiation Health and Research

• Regulates the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of health products, and institutes standards for the same.

Divisions under each Center

• Licensing and Registration Division: evaluates health products and establishments for the purpose of issuance of authorizations and conditions to be observed.
• Center for Cosmetic Regulation and Research: regulates the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of cosmetics and household/urban hazardous substances, and conducts research on their safety and quality.

Republic Act No. 3720 (Foods, Drugs, Devices, and Cosmetics Act)

• Ensures the safety and purity of foods and cosmetics, and the purity, safety, efficacy, and quality of drugs and devices.
• Objectives:
  • Establish standards and quality measures for foods, drugs, and devices and cosmetics.
  • Ensure pure and safe supply of foods and cosmetics, and pure, safe, efficacious, and good quality drugs and devices.
  • Ensure rational use of drugs and devices.

Definitions

• Batch number: a designation printed on the label of a drug or device that identifies the batch and permits the production history to be traced and reviewed.
• Cosmetic: articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
• Device: instruments, apparatus, or contrivances, including their components, parts, and accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals.
• Distribute: the delivery or sale of any health product for purposes of distribution in commerce, except that it does not include the manufacture or retail of such product.

Health Warning on Tobacco Products

• Health warning shall be located on the bottom portion of one front panel of every tobacco product package and occupy not less than 30% of such front panel.
• The warning shall appear in clearly legible type in black text on a white background with a black border.
• The health warning shall occupy a total area of not less than 50% of the total warning frame.

Ban on Sponsorships

• Beginning 1 July 2008, cigarette and tobacco companies are prohibited from sponsoring any sport, concert, cultural or art event, as well as individual and team athletes, artists, or performers where such sponsorship shall require or involve the advertisement or promotion of any cigarette or tobacco company, tobacco product or tobacco use.

Unlawful Acts

• Restrictions on Sampling: The distribution of samples of tobacco products to persons below 18 years old is prohibited.
• Implementing Agency: An Inter-Agency Committee—Tobacco (IAC-Tobacco) is hereby created to administer and implement the provisions of this Act.

Penalties

• Medium Penalty: an administrative fine of not less than PHP 100,000.00 but not more than PHP 300,000.00 and permanent closure of establishment as well as the revocation of its license to do business.
• Maximum Penalty: an administrative fine of not less than PHP 300,000.00 but not more than PHP 500,000.00 and permanent closure of establishment concerned as well as the revocation of its license to do business.