BFAD

: Republic Act No. 8203 is known as the "Special Law on Counterfeit Drugs."
: The original rules and regulations implementing RA 8203 were promulgated by the Bureau of Food and Drugs on November 19, 1996.
: Paragraph (h) Section 3 Rule 1 of the original implementing rules had a definition of counterfeit drugs/medicines that contradicted the provisions of RA 8203.
: The amended paragraph (h) Section 3 Rule I defines "Unregistered imported drug product".
: An "Unregistered imported drug product" refers to an unregistered imported drug product without a registered counterpart brand in the Philippines, distinguishing it from counterfeit drugs.
: The amendment took effect thirty (30) days after its publication in two newspapers of general circulation.
: The amendment was approved by Alberto G. Romualdez, Jr., M.D., Secretary of Health.
: The amendment was necessary to conform the definition to the provisions of RA 8203 after consultations with various sectors.
: An unregistered drug product is one that has not been registered by the Philippine authorities and has no registered counterpart brand in the country, differentiating it from counterfeit drugs which may be registered but are fake or mislabeled.