Republic Act

Topics: Drugs, Authentication, Pharmacology Pages: 10 (2856 words) Published: December 16, 2012

Begun and held in Metro Manila, on Monday, the twenty-second day of July, nineteen hundred and ninety-six



Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

SECTION 1. Title – This Act shall be known as the "Special Law on Counterfeit Drugs."

SECTION 2. Declaration of Policy -It is hereby the policy of the State to protect and promote the right to health of the people and instill health consciousness among them as provided in Section 15 Article 11 of the Constitution.

It is also further declared the policy of the State that in order to safeguard the health of the people, the State shall provide for their protection against counterfeit drugs.

SECTION 3. Definition of Terms – For purposes of this Act, the terms:

(a) Drugs shall refer to any chemical compound or biological substance, other than food, intended for use in the treatment, prevention or diagnosis of disease in man or animals, including but not limited to:

(1) any article recognized in the official United States Pharmacopoeia – National Formulary (USP-NF), official Homeopathic Pharmacopoeia of the United States, Philippines National Drug Formulary, British Pharmacopoeia, any National Compendium or any supplement to any of them; (2) any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; (3)any article other than food intended to affect the structure or any function of the body of man or animals; (4)any article intended for use as a component of any articles specified in clauses (1), (2), (3) not including devices or their components, parts, or accessories; and (5) herbal and/or traditional drugs which are articles of plant or animal origin used in folk medicine which are: (a) recognized in the Philippine National Drug Formulary; (b) intended for use in the treatment or cure or mitigation of disease symptoms, injury or body defect in man; (c) other than food, intended to affect the structure or any function of the body of man; (d) in finished or ready-to-use dosage form; and (e) intended for use as a component of any of the articles specified in clauses (a), (b), (c) and (d). (b) Counterfeit drug/medicine refers to medicinal products with the correct ingredients but not in the amounts as provided hereunder, wrong ingredients, without active ingredients, with sufficient quantity of active ingredient, which results in the reduction of the drug’s safety, efficacy, quality, strength or purity. It is a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products. It shall also refer to:

1) the drug itself or the container or labeling thereof or any part of such drug, container or labeling bearing without authorization the trademark, trade name or other identification mark or imprint or any likeness to that which is owned or registered in the Bureau of Patent, Trademark and Technology Transfer (BPTTT) in the name of another natural or juridical person;

2) a drug product refilled in containers by unauthorized persons if the legitimate labels or marks are used;

3) an unregistered imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical records;

4) a drug which contains no amount of or a different active ingredient or less than eighty percent (80%) of the active ingredient it purports to possess as distinguished from an adulterated drug including reduction or loss or efficacy due to expiration.

(c) Brokeringshall refer to any act of facilitating the disposal or sale or...
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