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What is the responsibility of the Licensing and Registration Division within the Center for Device Regulation, Radiation Health, and Research?
What is the responsibility of the Licensing and Registration Division within the Center for Device Regulation, Radiation Health, and Research?
- Regulating the manufacture of health products
- Evaluating health products and establishments for authorization (correct)
- Instituting standards for cosmetics and household substances
- Conducting research on cosmetics and household substances
Which entities are covered by the activities of the Center for Cosmetic Regulation and Research?
Which entities are covered by the activities of the Center for Cosmetic Regulation and Research?
- Manufacturers of household hazardous substances (correct)
- Importers of cosmetics
- Manufacturers of health products
- Distributors of health products
What is one of the responsibilities of the Center for Device Regulation, Radiation Health, and Research?
What is one of the responsibilities of the Center for Device Regulation, Radiation Health, and Research?
- Testing cosmetics for safety
- Promoting the use of household hazardous substances
- Instituting standards for health products (correct)
- Conducting research on health product advertisements
What type of substances are regulated by the Center for Cosmetic Regulation and Research?
What type of substances are regulated by the Center for Cosmetic Regulation and Research?
What is a specific focus area for the Center for Cosmetic Regulation and Research?
What is a specific focus area for the Center for Cosmetic Regulation and Research?
What is the administrative fine range for a medium penalty?
What is the administrative fine range for a medium penalty?
When is the maximum administrative penalty imposed?
When is the maximum administrative penalty imposed?
What is the minimum administrative fine for the maximum penalty?
What is the minimum administrative fine for the maximum penalty?
Under what circumstance is the medium administrative penalty imposed?
Under what circumstance is the medium administrative penalty imposed?
What triggers the permanent closure of an establishment under the medium penalty?
What triggers the permanent closure of an establishment under the medium penalty?
What constitutes a maximum administrative penalty?
What constitutes a maximum administrative penalty?
What is the minimum percentage of the front panel that the health warning should occupy on a tobacco product package?
What is the minimum percentage of the front panel that the health warning should occupy on a tobacco product package?
How should the text of the health warning appear in terms of color and background?
How should the text of the health warning appear in terms of color and background?
How often should the health warnings on tobacco product packages be rotated?
How often should the health warnings on tobacco product packages be rotated?
Where should the health warning not be placed to avoid potential damage or obscuration?
Where should the health warning not be placed to avoid potential damage or obscuration?
If a wrapper on a tobacco product package is likely to obscure or obliterate the warning, what must be done?
If a wrapper on a tobacco product package is likely to obscure or obliterate the warning, what must be done?
In addition to the health warning, what statement must be included on one side panel of tobacco product packages?
In addition to the health warning, what statement must be included on one side panel of tobacco product packages?
What is the primary focus of the section on Unlawful Acts Ban on Sponsorships?
What is the primary focus of the section on Unlawful Acts Ban on Sponsorships?
What is a key restriction mentioned in the section on Unlawful Acts Restrictions on Sampling?
What is a key restriction mentioned in the section on Unlawful Acts Restrictions on Sampling?
Who chairs the Inter-Agency Committee—Tobacco (IAC-Tobacco) according to the text?
Who chairs the Inter-Agency Committee—Tobacco (IAC-Tobacco) according to the text?
Which department serves as the Vice Chairperson of the IAC-Tobacco?
Which department serves as the Vice Chairperson of the IAC-Tobacco?
What is NOT allowed in terms of branding after the passage of this Act?
What is NOT allowed in terms of branding after the passage of this Act?
What function does the Inter-Agency Committee—Tobacco (IAC-Tobacco) have according to the text?
What function does the Inter-Agency Committee—Tobacco (IAC-Tobacco) have according to the text?
What is the main purpose of Republic Act No. 3720?
What is the main purpose of Republic Act No. 3720?
What is the role of the Bureau of Food and Drugs according to R.A. No. 3720?
What is the role of the Bureau of Food and Drugs according to R.A. No. 3720?
What does a batch number printed on the label of a drug or device indicate?
What does a batch number printed on the label of a drug or device indicate?
Which of the following is NOT considered a cosmetic according to R.A. No. 3720?
Which of the following is NOT considered a cosmetic according to R.A. No. 3720?
What falls under the definition of a 'Device' based on R.A. No. 3720?
What falls under the definition of a 'Device' based on R.A. No. 3720?
What does 'Distribute' refer to as defined in R.A. No. 3720?
What does 'Distribute' refer to as defined in R.A. No. 3720?
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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.
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