- RULE I INTERPRETATION AND DEFINITION OF TERMS
- RULE II PROHIBITED ACTS
- RULE III MONITORING OF COUNTERFEIT DRUGS
- Section 1. Procedure of Monitoring Counterfeit Drugs in the Market
- Section 2. Duration In the Conduct of Examination.
- Section 3. When There Is No Need For Laboratory Testing.
- Section 4. When To Refer To LICD For Investigation.
- Section 5. When The Product Is Found Not Counterfeit.
- Section 6. Accreditation of Complaint Desk.
- Section 7. Possession Of Counterfeit Drugs by Owners Of Trademarks, Trade Names Or Other Identifying Marks; When to Report.
- RULE IV PROCEDURE IN THE FILING OF ADMINISTRATIVE COMPLAINT
- Section 1. Where to File the Complaint.
- Section 2. Complaint Filed By A Registered Brand Owner.
- Section 3. Contents of the Complaint Affidavit.
- Section 4. Complaint Filed By A Consumer, A Physician Prescriber and Other Interested Party
- Section 5. When The Consumer, Physician Prescriber Or Interested Party May File An Affidavit Of Complaint And Not a Letter of Complaint.
- RULE V ADMINISTRATIVE PROCEEDINGS
- RULE VI APPEAL
- RULE VII ADMINISTRATIVE SANCTIONS
- Section 1. Minimum Penalty.
- Section 2.. Medium Penalty.
- Section 3. Maximum Penalty.
- Section 4. Accessory Penalties.
- Section 5. Proceedings Against the Registration of a Pharmacist.
- Section 6. When to File Criminal Charges.
- Section 7. When the Minimum Penalty Shall be Applied.
- Section 8. When the Medium Penalty Shall be Imposed.
- Section 9. When the Maximum Penalty Shall be Imposed.
- RULE VIII FINAL PROVISIONS
RULES AND REGULATIONS IMPLEMENTING AUTHORITY Pursuant to Section 11 of Republic Act No. 8203 otherwise known as the Special Law on Counterfeit Drugs, the following rules and regulations are hereby promulgated in consultation with the Secretary of Health.
RULE I Section 1. Short Title. These rules and regulations shall be cited as "IRR of R.A. 8203."
Section 2. Construction. The words and phrases used in these rules shall be interpreted to give meaning to the provisions of R.A. 8203 in order to safeguard the health of the people and to protect them from counterfeit drugs.
Section 3. Definition of Terms. In addition to the terms defined by Section 3 of R.A. 8203, and for purposes of these regulations, the term - RULE II Section 1. Prohibited Acts. The acts prohibited or declared unlawful under Section 4 of
R.A. 8203 are adopted as the same acts that are prohibited by these rules and therefore punishable by the administrative sanctions herein prescribed.
Section 2. Parties Liable. The parties who are liable under Section of R.A. 8203 are likewise made liable under these rules.
RULE III Section 2. Duration In the Conduct of Examination. The BFAD shall have twenty (20) working days to determine the genuineness and authenticity of the product.
Section 3. When There Is No Need For Laboratory Testing. When the geniuneness of the product can be determined by the mere physical examination of the product or the labeling thereof, the PSD shall conduct the examination or evaluation of the same. The result of the physical examination shall be reduced into a certification of findings.
The Regulation Division I may also require the registered brand-owner of the suspected counterfeit drug to certify whether or not the suspected drug product has been manufactured, imported and/or distributed by them; or whether they own the Lot Number and Expiry Date of the same suspected drug product. The certification issued by the registered brand-owner shall be supported by the batch, production and distribution records. However, the brand-owner's certification shall be validated by the PSD for evidentiary purposes.
Section 4. When To Refer To LICD For Investigation. When the result of examination shall confirm the suspicion of the FDRO that in fact the drug product is counterfeit, the LSD or PSD shall forward the result of examination to the LICD for a motu proprio investigation. Otherwise, the result of the examination shall be released to the Regulation Division concerned.
Section 5. When The Product Is Found Not Counterfeit. When the result of the examination reveals that the sample collected is genuine, the PSD or LSD shall forward the report of examination or evaluation to the FDRO through his/her division chief.
If the sealed and segregated products are within the Metro Manila area, the Regulation Division concerned shall, within sixteen (16) working hours from receipt of such report, notify the outlet or the communication available. However, only a FDRO can unseal the suspected product before it can be released for sale or distribution to legitimate commerce.
When the segregated and sealed products are located outside the Metro Manila area, the Regulation Division concerned shall send a notice to release the products to the Food and Drug Section having territorial jurisdiction over the same through the Regional Director within sixteen (16) working hours from receipt of the notice. The FDRO assigned in the said province shall, within sixteen 916) hours from receipt of the notice, unseal the suspected drugs for distribution to legitimate commerce
Section 6. Accreditation of Complaint Desk. Upon application by an interested pharmaceutical association. BFAD shall accredit complaint desks that may be established by any pharmaceutical organization or association. The desk shall receive and refer verifiable letter of complaint or information from any of its members about counterfeit drug products. Any letter of complaint or information referred to BFAD by such complaint desk shall be processed in accordance with Section 2 of Rule IV hereof.
Section 7. Possession Of Counterfeit Drugs by Owners Of Trademarks, Trade Names Or Other Identifying Marks; When to Report. Owners of trademarks, trade names or other identifying marks, or their authorized agents who have in their possession counterfeit drug product involving their own trademark, trade name or other identifying marks, shall report in writing and turn over the said counterfeit drugs to the BFAD within ten (10) days from the time of purchase or acquisition of such drugs as indicated in the sale invoices or official receipt or other similar documents. The sales invoice, official receipts or other similar documents shall be attached to the said report on counterfeit drugs. Failure to comply with this section will give rise to the presumption of violation as provided under Section 4(a) of R.A. 8203.
RULE IV Section 1. Where to File the Complaint. Any person may file a complaint whether in an affidavit or letter form with the BFAD LIC or in any BFAD Accredited Complaint Desk as provided for in Section 8 Rule II of this Order.
Section 2. Complaint Filed By A Registered Brand Owner. A drug establishment or a registered brand owner may file an administrative action against any person or establishment for any acts in violation of R.A. 8203 in the form of an affidavit of complaint.
Section 3. Contents of the Complaint Affidavit. The affidavit of complaint of the registered brand owner shall state- The affidavit of complaint shall be accompanied by samples of counterfeit drug products duly marked for identification purposes.
Section 4. Complaint Filed By A Consumer, A Physician Prescriber and Other Interested Party. A consumer, physician-prescriber or other interested party other than the registered brand owner may file a letter of complaint or information about a suspected counterfeit drug product. His letter shall state- Section 5. When The Consumer, Physician Prescriber Or Interested Party May File An Affidavit Of Complaint And Not a Letter of Complaint. When the consumer, physician-prescriber or the interested party is in possession of evidence to prove that the product is counterfeit and an act in violation of R.A. 8203 has been committed, he/she shall instead file an affidavit of complaint stating - He/she shall submit and offer the evidence in his/her possession specifically including the sample of the counterfeit drug product or the container of such product he shall allege as counterfeit. Such an affidavit of complaint shall be processed in accordance with Section 3 of the Rule IV hereof.
RULE V Section 1. When Initiated by BFAD FDROs. When the administrative action is initiated by FDRO, the FDRO shall submit a report of violation to the LICD. In the case the part-respondent manifests hi intention to present evidence in support of his position paper, the continuation of the hearing shall be conducted. Otherwise, the case shall be considered submitted for resolution based on evidence on record.
The administrative proceedings shall be completed and terminated within thirty (30)-day period; otherwise, if such proceedings cannot be completed within the thirty (30)-day period from notice, an order lifting the preventive closure shall be issued without prejudice to the resolution of the administrative case.
Section 2. Procedure When A Complaint Is Based On A Letter Of Complaint Or Information. issued and the administrative proceedings provided for in Section 1 hereof shall be instituted.
Section 3. Procedure When A Complaint is Initiated By a Drug Establishment Or Registered Brand Owner. (3) days before the date of hearing.
Section 4. Decision. Administrative cases under R.A. 8203 and these implementing rules and regulations shall be decided by the Director of BFAD within thirty (3) days from the date it shall be deemed submitted for decision.
Section 5. Finality of Decisions/Resolutions. Decisions and resolutions shall be final and executory after the lapse of fifteen (15) days from receipt of parties or from notice.
RULE VI Section 1. Motion For Reconsideration; When And When Not Allowed. No motion for reconsideration from an interlocutory order shall be allowed. Only one motion for reconsideration from the final resolution or decision shall be allowed and only upon the grounds that - Section 2. Appeal; When. The aggrieved party may appeal the decision of the BFAD Director within fifteen (15) days from receipt thereof to the Secretary of Health.
Section 3. Grounds For Appeal. No appeal shall be given due course on the following grounds - Section 4. How Made. A party who intends to appeal the decision of the BFAD Director shall file a notice of appeal with the BFAD. The BFAD shall forward the records of the case to the Office of the Secretary within fifteen (15) days from receipt of the notice of appeal.
Section 5. Execution Pending Appeal. The appeal when filed by a respondent shall not stay the execution of the decision, unless a bond in the amount of One Hundred Thousand Pesos (PHP 100,000.00), which is the minimum administrative fine imposable, is posted.
RULE VII Section 1. Minimum Penalty. An administrative fine of not less than of One Hundred Thousand Pesos (PHP 100,000.00) but not more than of Five Hundred Thousand Pesos (PHP 500,000.00) shall be the minimum administrative penalty.
Section 2.. Medium Penalty. An administrative fine of not less than of Three Hundred Thousand Pesos (PHP 300,000.00) but not more than of Five Hundred Thousand Pesos (PHP 500,000.00) and permanent closure of establishment as well as the revocation of its license to do business shall be the medium administrative penalty
Section 3. Maximum Penalty. An administrative fine of not less than of Three Hundred Thousand Pesos (PHP 300,000.00) but not more than of Five Hundred Thousand Pesos (PHP 500,000.00 ) and permanent closure of establishment concerned as well as the revocation of its license to do business shall be the maximum administrative penalty
Section 5. Proceedings Against the Registration of a Pharmacist. If the offense shall be committed with the actual or constructive knowledge of the registered pharmacist, the administrative sanction that shall be imposed shall be accompanied by the filing of certificate of violation for the appropriate proceeding against said pharmacist with the Professional Regulation Commission to cancel her/his professional license.
Section 6. When to File Criminal Charges. Criminal charges shall be filed against the party liable when the evidence found by BFAD is considered sufficient to establish a probable cause and the drug products involved are life saving or if the drug products are not life saving, the volume or number of the drug products subject to the case will manifest the criminal intent to the party liable to introduce into commerce counterfeit drug products. This, however, shall not preclude any interested party from initiating a criminal action against the party liable independent of BFAD.
Section 7. When the Minimum Penalty Shall be Applied. The minimum administrative penalty shall be imposed when the counterfeit drug products subject of the case are not life saving drugs and the volume of the said products is not worth more than (PHP 100,000.00); or the number of drug product subject of the case it not more than three brands or generic products.
Section 8. When the Medium Penalty Shall be Imposed. The medium administrative penalty shall be imposed when the counterfeit drug products subject of the case are not life saving drugs and the volume of the said products is not worth (PHP 100,000.00) but not exceeding One Million Pesos (PHP 1,000,000.00) or the number of counterfeit drug products is more than three brands or generic products.
Section 9. When the Maximum Penalty Shall be Imposed. The maximum administrative penalty shall be imposed when the counterfeit drug products are life saving drugs regardless of the volume; or the volume of the counterfeit drug products is worth more than One Million Pesos (PHP 1,000,000.00)
RULE VIII Section 1. Separability If, for any reason, any part or provision of these rules and regulations shall be held to be unconstitutional or invalid, other parts or provision hereof which are not affected thereby shall continue to be in full force and affect.
Section 2. Prospectivity. The administrative sanctions herein imposed shall not apply to acts committed prior to October 26, 1996 or the effective of the law R.A. 8203.
Section 3. Amendments. These rules and regulations may be amended, modified or supplemented when effective implementation and enforcement of R.A. 8203 would require.
Section 4. Effectivity. This Order shall take effect thirty days after its publication in two
(2) newspapers of general circulation.
(Sgd) QUINTIN L. KINTANAR, M.D., Ph.D., CESO I
Director
In consultation with the Department of Health:
(Sgd) CARMENCITA NORIEGA-REODICA, MD, MPH., CESO II
Secretary of Health
Date of Issuance: November 19, 1996
REPUBLIC ACT NO. 8203 OTHERWISE KNOWN AS
THE SPECIAL LAW ON COUNTERFEIT DRUGS
INTERPRETATION AND DEFINITION OF TERMS
PROHIBITED ACTS
MONITORING OF COUNTERFEIT DRUGS
Section 1. Procedure of Monitoring Counterfeit Drugs in the Market
PROCEDURE IN THE FILING OF ADMINISTRATIVE COMPLAINT
ADMINISTRATIVE PROCEEDINGS
APPEAL
ADMINISTRATIVE SANCTIONS
Section 4. Accessory Penalties.
FINAL PROVISIONS