Podcast Beta
Questions and Answers
What is the responsibility of the Licensing and Registration Division within the Center for Device Regulation, Radiation Health, and Research?
Which entities are covered by the activities of the Center for Cosmetic Regulation and Research?
What is one of the responsibilities of the Center for Device Regulation, Radiation Health, and Research?
What type of substances are regulated by the Center for Cosmetic Regulation and Research?
Signup and view all the answers
What is a specific focus area for the Center for Cosmetic Regulation and Research?
Signup and view all the answers
What is the administrative fine range for a medium penalty?
Signup and view all the answers
When is the maximum administrative penalty imposed?
Signup and view all the answers
What is the minimum administrative fine for the maximum penalty?
Signup and view all the answers
Under what circumstance is the medium administrative penalty imposed?
Signup and view all the answers
What triggers the permanent closure of an establishment under the medium penalty?
Signup and view all the answers
What constitutes a maximum administrative penalty?
Signup and view all the answers
What is the minimum percentage of the front panel that the health warning should occupy on a tobacco product package?
Signup and view all the answers
How should the text of the health warning appear in terms of color and background?
Signup and view all the answers
How often should the health warnings on tobacco product packages be rotated?
Signup and view all the answers
Where should the health warning not be placed to avoid potential damage or obscuration?
Signup and view all the answers
If a wrapper on a tobacco product package is likely to obscure or obliterate the warning, what must be done?
Signup and view all the answers
In addition to the health warning, what statement must be included on one side panel of tobacco product packages?
Signup and view all the answers
What is the primary focus of the section on Unlawful Acts Ban on Sponsorships?
Signup and view all the answers
What is a key restriction mentioned in the section on Unlawful Acts Restrictions on Sampling?
Signup and view all the answers
Who chairs the Inter-Agency Committee—Tobacco (IAC-Tobacco) according to the text?
Signup and view all the answers
Which department serves as the Vice Chairperson of the IAC-Tobacco?
Signup and view all the answers
What is NOT allowed in terms of branding after the passage of this Act?
Signup and view all the answers
What function does the Inter-Agency Committee—Tobacco (IAC-Tobacco) have according to the text?
Signup and view all the answers
What is the main purpose of Republic Act No. 3720?
Signup and view all the answers
What is the role of the Bureau of Food and Drugs according to R.A. No. 3720?
Signup and view all the answers
What does a batch number printed on the label of a drug or device indicate?
Signup and view all the answers
Which of the following is NOT considered a cosmetic according to R.A. No. 3720?
Signup and view all the answers
What falls under the definition of a 'Device' based on R.A. No. 3720?
Signup and view all the answers
What does 'Distribute' refer to as defined in R.A. No. 3720?
Signup and view all the answers
Study Notes
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.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Description
Test your knowledge on the key provisions and objectives of Republic Act No. 3720, also known as the 'Foods, Drugs, Devices and Cosmetics Act'. Explore the regulations aimed at ensuring the safety, purity, and quality of foods, drugs, devices, and cosmetics available to the public.