This Act shall be known as the “Special Law on Counterfeit Drugs.”
RA 8203
any chemical compound or biological substance, other than food, intended for use in the treatment, prevention or diagnosis of disease in man or animals
drugs
refers to medicinal products with the correct ingredients but not in the amounts as provided hereunder, wrong ingredients, without active ingredients, with sufficient quantity of active ingredient, which results in the reduction of the drug’s safety, efficacy, quality, strength or purity.
Counterfeit drug/medicine
shall refer to any act of facilitating the disposal or sale or counterfeit drugs, including acts of agency
Brokering
Bureau shall refer to the
Bureau of Food and Drugs (BFAD) of the Department of Health (DOH)
shall refer to any entity, whether a single proprietorship, partnership, or corporation engaged in or doing business in the Philippines
Business establishment
shall refer to a person or group of persons who is the registered owner of a license to operate a business or business undertaking in the Philippines or the branch manager or operator, licensee, franchisee, or any person acting on behalf of he corporate entity
Owner
shall refer to a private dwelling or abode where a person lives, either as owner or lessee, or usurfructuary including, for purposes of this Act, its yard, garage, storage rooms or premises
Residence
Penalty for Possession of counterfeit drugs (Section 4b):
Imprisonment: 6 months and 1 day to 6 years.
Penalty for Other offenses under Section 4:
Imprisonment: 6 years and 1 day to 10 years, and/or
Fine: ₱100,000 to ₱500,000.
Penalty if Counterfeit drugs intended for animals:
Imprisonment: 6 months and 1 day to 2 years and 4 months.
Penalty for Tampering or concealing sealed drugs (Section 6a) For manufacturers, sellers, distributors:
Imprisonment: 6 years and 1 day to 10 years.
Penalty if If the counterfeit drug worsens illness or causes injury:
Imprisonment: 12 to 15 years,
Fine: ₱100,000 to ₱500,000.
Penalty for Tampering or concealing sealed drugs (Section 6a) For any other person:
Imprisonment: 6 months and 1 day to 6 years.
Penalty If counterfeit drug causes death:
Penalty: Life imprisonment
Fine: ₱500,000 to ₱5,000,000.
Approval of RA 8203
September 4, 1996
Shall mean, that by exercise of reasonable care, one would have known the fact or suspect that the drug product he or she has sold or in possession of is counterfeit, such as but not limited to the knowledge that the drug was not covered by any sales invoice or evidence of delivery
of purchase from a BFAD license drug establishment.
Constructive Knowledge
shall refer to drug products indicated for life threatening
condition(s)
Life saving drugs
shall refer to unregistered imported drug product without a registered counterpart brand in the Philippines. If the unregistered imported drug product has a registered counterpart brand in the Philippines, their product shall be considered counterfeit.
Unregistered imported drug product
The BFAD shall have __ working days to determine the genuineness and authenticity of the product.
twenty (20)
If the sealed and segregated products are within the Metro Manila area, the Regulation Division concerned shall, within __ working hours from receipt of such report, notify the outlet or the communication available.
sixteen (16)
However, only a __ can unseal the suspected product before it can be released for sale or distribution to legitimate commerce.
FDRO
