AMENDMENT TO THE RULES AND REGULATIONS IMPLEMENTING REPUBLIC ACT NO. 8203 OTHERWISE KNOWN AS THE “SPECIAL LAW ON COUNTERFEIT DRUGS”

National Administrative Register November 19, 1996 [ BFAD, January 31, 2000 ]



WHEREAS, the Bureau of Food and Drugs promulgated on November 19,
1996 the rules and regulations implementing Republic Act No. 8203
otherwise known as the “Special Law on Counterfeit Drugs”.

WHEREAS, a perusal of paragraph (h) Section 3 Rule 1 of said rules
shows that the definition of counterfeit drugs/medicines provided
therein contradicts the provisions of R.A. 8203;

WHEREFORE, after a series of consultations conducted by the
Department of Health with various sectors and in order to conform with
the provisions of R.A. 8203, paragraph (h) Section 3 Rule I is hereby
amended and shall now read, as follows:

h)  “Unregistered imported drug product” as distinguished from
counterfeit drug defined under Section 3 of R.A. 8203, shall refer to
unregistered imported drug product without a registered counterpart
brand in the Philippines.

This Amendment shall take effect thirty (30) days after its publication in two (2) newspapers of general circulation.

Adopted: 31 Jan. 2000

(SGD.) WILLIAM D. TORRES, PH.D.
Director

Approved:

(SGD.) ALBERTO G. ROMUALDEZ, JR. M.D.
Secretary of Health