Safety Features Required by the Falsified Medicines Directive 2011/62/EU

Transcription

1 TOPRA Annual Human Medicines Symposium 2017 Safety Features Required by the Falsified Medicines Directive 2011/62/EU Syed Qadri, Global Regulatory Affairs Strategy EU/ROW Jazz Pharmaceuticals ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

2 Disclaimer: The views and opinions expressed in this presentation are those of the author and do not necessarily reflect the official policy or position of Jazz Pharmaceuticals

3 Presentation Objectives - Delegated Act on Safety Features: Regulation EU 2016/161 - European Medicines Verification System (EMVS) model - Data and serialisation requirements - Verification and data exchange as a pharma company - Normal distribution, multiple wholesalers and returned products - Parallel Importers - Wholesale Distributor and Pharmacy Verification - Products affected

4 Delegated Act on Safety Features: Regulation EU 2016/161 API/Excipient GMP Safety Features Unique Identifier Anti-tampering Device Distribution GDP Internet Pharmacies

5 European Medicines Verification System (EMVS) Model EUROPEAN HUB Pharmaceutical Drug Manufacturer Distributor/Broker/ Parallel Importer - Primary/Secondary Packaging - Contract Manufacturer Member State National Repository Member State National Repository Wholesaler Pharmacy Wholesaler Pharmacy

6 Data Requirements for Reporting Before the product is release for sale, MAH generates extensive data about the product, packaging with respect to its identity: Product code Name, form, strength, pack type, pack size Target market (member state) Manufacturer business info (safety feature applier) MAH/manufacturer name and address MAH authorised wholesalers: Store/distribute on behalf Whitelist flag Serialised identifier data elements

7 Product Technical Serialisation Requirement 2D Bar Code (Data Matrix ECC200): Minimum print quality Human-readable format Four composition elements: 1. Manufacturer product code: ISO-compliant (ISO 15459) less than 50 characters 2. Serial number (max 20 and randomised) 3. Batch number 4. Expiry data Optional: national reimbursement number

8 Verification Data Exchange as a Pharma Company EUROPEAN HUB Pharmaceutical Drug Manufacturer - Primary/Secondary Packaging - Contract Manufacturer Member State National Repository Member State National Repository Distributor/Broker/Parallel Importer Wholesaler Pharmacy Wholesaler Pharmacy Complex data exchange: Product master data, serialisation data and serialised data events with internal packaging sites Shipment, decommissioning of damaged products Master data serialisation transfer with European hub European hub product status update Recall notification with European hub European hub product inquiry

9 Safety Features Typical Distribution Model (1) Pharmaceutical Drug Manufacturer Wholesaler Pharmacy Patient Verification at dispense EUROPEAN HUB Member State National Repository

10 Safety Features Multiple Wholesaler Model (2) Pharmaceutical Drug Manufacturer Wholesaler Wholesaler Pharmacy Patient RISK BASED VERIFICATION Verification at dispense EUROPEAN HUB Member State National Repository

11 Safety Features Product Return (3) Returned Product Pharmaceutical Drug Manufacturer Wholesaler Wholesaler Pharmacy Patient RISK BASED VERIFICATION Verification at dispense EUROPEAN HUB Member State National Repository

12 Safety Features Parallel Importers PI requirements depend on: Repackaging/relabelling Serialisation Product purchase NOT from original manufacturer Sale to outside EU Product is repackaged/relabelled Purchased products Product returned Verification PI Compliance Reporting Sale outside normal supply chain: Verification Decommissioning Product master data (Name, form, strength, package type, package size) Unique package identifier (Manufacturing product code, serial number, expiry date, batch number)

13 Safety Features Parallel Importers Pharmaceutical Drug Manufacturer Wholesaler PARALLEL IMPORTER Pharmacy Patient 2. Product data upload Verification and/or Decommissioning Verification at dispense EUROPEAN HUB Member State National Repository

14 Wholesale Distributor & Pharmacy Verification Wholesaler risk-based verification: - Not supplied directly from original manufacturer or MAH - Returned product by another wholesale distributor/pharmacy EXCEPTIONS: 1. Ownership change of product whilst still in possession of wholesaler 2. Transfer of product between facilities of same owner within member state Verification AND Decommissioning required when supplying to: Medical Practitioner Vet/vet retailers Dentist PHARMACY DISPENSER VERIFICATION Optometrist Paramedic Armed forces/police (civil protection) PRODUCT DISPENSE ELSEWHERE University Research Prison, school, hospice, nursing homes

15 What's covered and what not? OTC Inclusions (Black List) Omeprazole??? OTC Rx exemptions (White List) Rx OTC

16 Safety Features Considerations Uniqueness (S/N) Guarantee 1 year after expiry 5 years after insertion in supply chain Exceptions Package release before 9 th Feb 2019 sold until expiry Not repacked or relabelled Countries with schemes already in place Belgium, Italy, Greece Defer application of articles 1 48 by up to 6 years

17 Presentation Objectives: Recap - Delegated Act on Safety Features: Regulation EU 2016/161 - European Medicines Verification System (EMVS) model - Data and serialisation requirements - Verification and data exchange as a pharma company - Normal distribution, multiple wholesalers and returned products - Parallel Importers - Wholesale Distributor and Pharmacy Verification - Products affected

18 Official Journal of the European Union. Commission Delegated Regulation (EU) 2016/ /reg_2016_161/reg_2016_161_en.pdf European Commission. Medicines verification in Europe: What to expect in _stakeholders_workshop_final.pdf Syed Qadri. DIA-TOPRA Workshop on Falsified Medicines, Regulatory Rapporteur October 2016; Vol. 13, no. 10, pp: Syed Qadri. Requirements of the Falsified Medicines Directive s Delegated Act on Safety Features, Regulatory Rapporteur April 2017; Vol. 14, no. 4, pp: 8-11 Syed Qadri, Global Regulatory Affairs Strategy EU/ROW Jazz Pharmaceuticals Syed.Qadri@jazzpharma.com ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION