AMENDMENT TO THE RULES AND REGULATIONS IMPLEMENTING REPUBLIC ACT NO. 8203 OTHERWISE KNOWN AS THE “SPECIAL LAW ON COUNTERFEIT DRUGS”
January 31, 2000
REPUBLIC ACT No. 8203
IMPLEMENTING RULES & REGULATIONS
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.” chanroblespublishingcompany
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; chanroblespublishingcompany
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: chanroblespublishingcompany
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. chanroblespublishingcompany
(SGD.) WILLIAM D. TORRES, PH.D.
Director
Approved:
(SGD.) ALBERTO G. ROMUALDEZ, JR. M.D.
Secretary of Health
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