Amendment to Rules Implementing RA 8203 on Counterfeit Drugs

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BFAD: Amendment to Rules Implementing RA 8203 on Counterfeit Drugs

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Title Supreme Court: Amendment to Rules Implementing RA 8203 on Counterfeit Drugs

Law: Bfad

Decision Date: Jan 31, 2000

The Bureau of Food and Drugs amends the definition of "unregistered imported drug product" to clarify its distinction from counterfeit drugs, ensuring compliance with Republic Act No. 8203.

counterfeit drugs

administrative law

drug regulation

A

Clarification on "Unregistered Imported Drug Product"

The amendment redefines "Unregistered imported drug product" as a distinct category, separate from counterfeit drugs.
Specifically, it refers to an imported drug product that is unregistered and has no registered counterpart brand in the Philippines.
This clarification distinguishes unregistered imported drugs from counterfeit drugs as defined under Section 3 of R.A. 8203.

Procedural and Implementation Details

The amendment was issued following consultations by the Department of Health with various stakeholders.
It aims to ensure conformity with the provisions of R.A. 8203.
The amendment took effect thirty (30) days after its publication in two newspapers of general circulation.

Legal and Administrative Authority

The amendment was promulgated by the Bureau of Food and Drugs, under the authority of the Department of Health.
It was signed by the Director of the Bureau of Food and Drugs, William D. Torres, Ph.D.
The Secretary of Health at the time, Alberto G. Romualdez, Jr., M.D., approved the amendment.

END