Question & AnswerQ&A (BFAD)
The rules and regulations shall be cited as the "IRR of RA 8203."
Constructive knowledge means that by exercising reasonable care, one would have known or suspected that the drug product sold or possessed is counterfeit, such as when the drug is not covered by any sales invoice or evidence of delivery or purchase from a BFAD licensed drug establishment.
FDROs inspect factories, warehouses, establishments, or vehicles without prior notice to detect counterfeit drugs. They inventory, segregate, seal suspected stocks, collect samples for examination, and require documents proving the authenticity of the drugs.
If the product is found genuine, the PSD or LSD forwards the report to the FDRO. The Regulation Division must notify the outlet or drug establishment within 16 working hours to release the product. Only an FDRO can unseal the product before it is released for sale or distribution.
Penalties include administrative fines ranging from PHP 100,000 to PHP 500,000, permanent closure of establishments, revocation of business licenses, forfeiture and destruction of counterfeit products, and possible professional license cancellation for pharmacists involved.
The maximum penalty applies when counterfeit drugs are life-saving regardless of volume, or when the volume of counterfeit drugs is worth more than PHP 1,000,000.
Appeals may be made on grounds of abuse of discretion, lack of substantial evidence supporting the decision, or irregularity in the conduct of the investigation.
A registered brand owner files an affidavit of complaint specifying the counterfeit product, lot numbers, expiry dates, the party respondents, acts complained of, and requested relief. Complaints should be accompanied by samples marked for identification.
They must report in writing and turn over the counterfeit drugs to BFAD within 10 days from acquisition, attaching sales invoices or receipts. Failure to report presumes violation under Section 4(a) of RA 8203.
BFAD has twenty (20) working days to complete the examination to determine the authenticity and genuineness of the drug product.