Counterfeit monitoring licensing
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Transcript of Counterfeit monitoring licensing
Republic of the PhilippinesDepartment of Health
Food and Drug Administration
Counterfeit Monitoring
Product Research and Standards Development DivisionCenter for Drug Regulation and Research
Presentation Outline
• Counterfeit Medicines• Current Legislation on Counterfeit
medicines• Local incidence• Product Verification Process
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What are counterfeit drugs?
World Health Organization (SSFFC)SubstandardSpuriousFalsely LabeledFalsified andCounterfeit Medical Products
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What are counterfeit drugs?
It is a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source. (World Health Organization)
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What are counterfeit drugs?
(World Health Organization)
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What are counterfeit drugs?
correct ingredients wrong ingredients
without active ingredientsinsufficient ingredients
fake packaging (World Health Organization)
Republic of the PhilippinesDepartment of Health
Food and Drug Administration
Current Legislation on Counterfeit medicines
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Republic Act No. 8203
Special Law on Counterfeit Drugs• Enacted on 06 September 1996• Effective on 27 October 1996
Generally prohibits activities related to the importation, manufacture, sale, distribution or mere possession of “counterfeit drugs”
Refers to medicinal products
correct ingredients but not in the amounts as provided
wrong ingredientswithout active ingredients
insufficient quantity of active ingredient reduction of the drug’s safety, efficacy, quality, strength or
purity
Counterfeit drug/medicine
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Counterfeit drug/medicineBearing without authorization the trademark, trade name or other identification mark or imprint or any likeness to that which is owned or registered in the Bureau of Patent, Trademark and Technology Transfer (BPTTT) in the name of another natural or juridical person
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Counterfeit drug/medicine
refilled in containers by unauthorized persons if the legitimate labels or marks are used;
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Counterfeit drug/medicinean unregistered imported drug product (with registered counterpart brand in the Philippines)
EXCEPT drugs brought in the country for personal use as confirmed and justified by accompanying medical records
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a drug which contains no amount of or a different active ingredient or less than eighty percent (80%) of the active ingredient it purports to possess as distinguished from an adulterated drug including reduction or loss or efficacy due to expiration.
Counterfeit drug/medicine
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Manufacture, sale, or offering for sale, donation, distribution, trafficking, brokering, exportation, or importation
Prohibited Acts
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Possession of any such counterfeit drugs
Prohibited Acts
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Forging, counterfeiting, simulating or falsely representing, or without proper authority, using any mark, stamp, tag, label or other identification mark or device authorized or required by Republic Act No. 3720
Prohibited Acts
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• Manufacturer, exporter or importer of the counterfeit drugs and their agents
• The seller, distributor, trafficker, broker or donor and their agents• The possessor of counterfeit drugs • The manager, operator or lessee of the laboratory or laboratory
facilities • The owner, proprietor, administrator or manager of the drugstore,
hospital pharmacy or dispensary, laboratory or other outlets or premises
• The registered pharmacist of the outlet where the counterfeit drug is sold or found, who sells or dispenses such drug to a third party and who has actual or constructive knowledge that said drug is counterfeit
Parties Liable
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Any person may file a complaint
IRR of 8203RULE IV: PROCEDURE IN THE FILING OF ADMINISTRATIVE COMPLAINT
Filing Of Administrative Complaint
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Filing Of Administrative Complaint
Brand owner
Affidavit of complaint
Consumer
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Letter of complaint
Submitted together with samples
Letter of complaint–Name of product–Source or the name and address of the
person from whom the product was acquired–Mode of acquisition–Reason or fact giving rise to the suspicion
Filing of Administrative Complaint
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Republic of the PhilippinesDepartment of Health
Food and Drug Administration
Local Incidence
Commonly counterfeited• Popular medicines with high demand– Antihypertensive, Antibiotics
Local incidence
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Local incidence• Lifestyle medicines
- slimming products- products for erectile dysfunction containing ingredients
present in Viagra or Cialis
• Patented medicines
Local incidence
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• Leading branded-generic medicines in the market
Local incidence
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Unregistered Drugs
• Licensing requirements for drug establishments
• Post market surveillance and enforcement
• Internal Collaboration (CDRR, RFO, CHDs, LSSC, REU)
• In-house lab testing of drug products
Strategies in place
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• Collaboration with local enforcement agencies (PNP/NBI/CIDG)
• Collaboration with stakeholders/companies
• International collaboration (ASEAN, WHO, Interpol)
• Consumer advisories to increase public awareness
Strategies in place
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• Active Surveillance– Stimulated reporting (Enforcement agencies)– Data gathering (FDA Routine PMS)
• Passive Surveillance– Consumer/Stakeholders Complaints
Source of Reports for Suspected Counterfeit Drug Products
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Republic of the PhilippinesDepartment of Health
Food and Drug Administration
Verification of Suspected Counterfeit Products
Suspected Counterfeit Products
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1• Collection/Receipt
2• Evaluation
3• Enforcement Action
Sources: • FROO, CHDs• PNP/NBI• Reports from Concerned Citizen• Reports from company• Central Laboratory
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1• Collection/Receipt of Report
Referral Letter + Sample
What are the necessary information? • Information on Samples : –Name–No. of samples submitted – Batch No./ Lot No. –Manufacturer/Distributor –Date of Manufacture – Expiry date
Submission of Reports
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What are the necessary information? • Name of Source• Location/Address• Sales invoice/Official documents• If available–Date of sampling –Requesting Officer
Submission of Reports
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Center for Drug Regulation and Research
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2•Evaluation
References– Republic Act 8203
– Administrative Order No. 55 s. 1988
– Department Circular No. 2011 – 0101
– Product Dossier
Evaluation of Suspected Counterfeit Product
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Evaluation of Suspected Counterfeit Product
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Referral Letter + Sample
Validate the information
Physical Evaluation
Can conclude?
Certification
Verify from MAH
Laboratory AnalysisYes
No
Section 3 of the IRR of RA 8203The Center [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 for evidentiary purpose.
Evaluation of Suspected Counterfeit Product
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Verify from MAH
Evaluation Results• Unregistered drug product
• Unregistered with registered counterpart brand
• Counterfeit drug product40
2•Evaluation
Evaluation Results• Registered and compliant to approved label/
labeling requirements
• Registered but non-compliant to approved label/ labeling requirements
• Out of specifications
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2•Evaluation
Most common signs that a medicine is unregistered:
2•Evaluation
purchased in an unlicensed outlet/establishment and was not issued with an official receipt
no name and address of any drug establishment licensed in the Philippines
no drug registration number
foreign markings
Basis:• Republic Act No. 3720: Food, Drug, and
Cosmetic Act• Administrative Order No. 55 s. 1988• Bureau Circular No. 05 s. 1997
Generic Labeling Exemption
Grounds:• Administrative Order No. 55 s. 1988– Primary pack is enclosed in transparent covering
and the particulars are clearly visible– Compounded by a pharmacist– Investigational Products– Donated Products
Generic Labeling Exemption
Grounds:• Bureau Circular No. 05 s. 1997– Service item– Specially packed– Low volume of importation• < 500 units/ month or 6000 units/ yr
– Drug product requires special handling
Generic Labeling Exemption
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2•Evaluation
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2•Evaluation
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2•Evaluation
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2•Evaluation
• Appropriate Administrative Sanctions
• Closure of Case
FROO - RFOREULSSC
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3•Enforcement Action
Republic of the PhilippinesDepartment of Health
Food and Drug Administration
National Consciousness Week Against
Counterfeit Medicines
16 – 20 November 2015
Presidential Proclamation No. 2082 dated 15 June 2010
Republic of the PhilippinesDepartment of Health
Food and Drug Administration
Mamamayan Makialam, Pekeng Gamot Labanan.
Republic of the PhilippinesDepartment of Health
Food and Drug Administration
Thank you!