Interpretation and Definitions (Rule I)
- Rules cited as "IRR of RA 8203."
- Interpretation consistent with the intent of RA 8203 to protect health from counterfeit drugs.
- Key definitions include:
- Bureau or BFAD: Bureau of Food and Drugs.
- Constructive knowledge: Awareness or reasonable suspicion regarding the counterfeit nature of drug products.
- FDRO: Food and Drug Regulation Officer.
- LICD: Legal, Information and Compliance Division of BFAD.
- Life-saving drugs: Drugs indicated for life-threatening conditions.
- LSD: Laboratory Services Division of BFAD.
- PSD: Product Services Division of BFAD.
- Unregistered imported drug product: Unregistered imported drug without a registered counterpart; if counterpart exists, considered counterfeit.
Prohibited Acts and Parties Liable (Rule II)
- Prohibited acts mirror those under Section 4 of RA 8203.
- Administrative sanctions apply for prohibited acts.
- Parties liable under Section 5 of RA 8203 also liable under these rules.
Procedures for Monitoring and Identifying Counterfeit Drugs (Rule III)
- FDROs conduct inspections without prior notice in factories, warehouses, establishments, or vehicles.
- Inspection includes raw materials, finished products, containers, and labeling.
- Suspected counterfeit stocks are inventoried, segregated, sealed, and samples collected for examination.
- Owners must produce sales invoices or delivery documents from BFAD licensed establishments.
- Samples submitted to LSD or PSD for examination to determine authenticity.
- BFAD has 20 working days to complete examination.
- Physical examination without lab testing allowed if product authenticity can be determined visually by PSD.
- Certification from the registered brand-owner may be required and validated by PSD.
- Positive counterfeit findings forwarded to LICD for investigation.
- If not counterfeit, product release procedures involve notification and unsealing by FDRO.
- Complaint desks accredited by BFAD may receive and refer complaints.
- Trademark owners must report and surrender counterfeit drugs within 10 days of acquisition, or face legal presumptions.
Filing of Administrative Complaints (Rule IV)
- Complaints may be filed with BFAD LICD or accredited complaint desks.
- Registered brand owners must file affidavits detailing product information, respondents, violations, and relief sought, with product samples.
- Consumers, physicians, or interested parties may file letters of complaint stating suspected product details and reasons for suspicion.
- Affidavits required if sufficient evidence and direct accusation exist.
Administrative Proceedings (Rule V)
- Initiated by FDROs submitting violation reports to LICD.
- LICD prepares memorandum of evidence and gives respondents 15 days to respond.
- Preventive closure orders for 30 days may accompany charges against establishments.
- Summary hearings conducted if factual disputes arise; cross-examination permitted.
- Administrative cases decided within 30 days after submission.
- Decisions become final 15 days after receipt by parties.
Appeal Process (Rule VI)
- No interlocutory motions for reconsideration allowed; one motion for reconsideration on final decisions permitted.
- Grounds for appeal include abuse of discretion, lack of substantial evidence, and procedural irregularities.
- Appeals filed within 15 days to the Secretary of Health.
- Filing an appeal does not stay execution unless a bond of PHP 100,000 is posted.
Administrative Sanctions (Rule VII)
- Minimum penalty: PHP 100,000 to PHP 500,000 fine.
- Medium penalty: PHP 100,000 to PHP 300,000 fine, permanent closure of establishment, license revocation.
- Maximum penalty: PHP 300,000 to PHP 500,000 fine, permanent closure, license revocation.
- Accessory penalties include forfeiture, confiscation and destruction of counterfeit products and related equipment.
- Permanent disqualification from operating businesses under BFAD supervision applies with maximum penalties.
- Registered pharmacists with knowledge of violations face professional license cancellation proceedings.
- Criminal charges possible when evidence shows probable cause, especially for life-saving drugs or large volumes.
- Penalties graduated based on drug type (life-saving or not) and volume/value of counterfeit drugs.
Final Provisions (Rule VIII)
- Separability clause preserving unaffected provisions if some parts are invalidated.
- Sanctions apply prospectively; not retroactive before enactment.
- Rules may be amended to improve enforcement.
- Effective 30 days after publication in newspapers.