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