Evaluation of Counterfeit Cases Impact of FMD & GDPs. Lorraine Nolan Healthcare Products Distribution Manager

Transcription

1 Evaluation of Counterfeit Cases Impact of FMD & GDPs Wholesale Distribution Information Day, 28th September 2012 Lorraine Nolan Healthcare Products Distribution Manager Slide 1

2 Contents 1. Review of UK counterfeit cases & contributory factors 2. Review of legislative & regulatory developments and their preventative effects FMD Revised EU GDPs Slide 2

3 UK: Case 1 Operation Singapore Contributory Factors 1. Lack of Due Diligence 2. Strong Commercial Incentive 3. Lack of Information Exchange Slide 3

4 Complex Supply Chain Non-legitimate participants Wholesalers- Luxembourg - Belgium Trading entity-ireland Parallel Traders Legitimate participants Re-packagers Wholesale Pharmacy Slide 4

5 Factor 1: Due Diligence FMD & Revised EU GDP Requirements Due Diligence Requirements Supplier Evaluation Consideration of all Participants in the Supply Chain On-Going Evaluation & Monitoring of Change Slide 5

6 Due Diligence: Supplier Evaluation Review of EUDRA GDP Certification Use of QRM Parallel traded product Need for heightened evaluation Review of Authorisations Audit of Suppliers Evaluation of Product Supply Route Identification of product sources & evaluation of their compliance Slide 6

7 Due Diligence: Supplier Evaluation Supplier Evaluation QRM Approach Technical & Quality Agreement Documented Outcome Roles & Responsibilities Authorisation & GDP Compliance Supply Chain Review Provision* *Critical component for monitoring of change Slide 7

8 Due Diligence: Participants in the Supply Chain Chain included trading entity Evaluation of Verification of involvement authorisation Required to be authorised EUDRA GDP Trading Evaluation Entity of role within chain Requirement for audit EUDRA GDP Slide 8

9 Factor 2: Strong Commercial Incentive X Packs 1,000 Packs Increased Availability of Product Strongly linked with due diligence for supplier evaluation Trigger for QRM Approach Review of the T&Q Agreement Review of supply chain Justification for the increase Slide 9

10 Factor 3: Information Exchange Suspicions relating to possible falsified medicine, not divulged to CA Mandatory requirements for information exchange relating to falsified medicines FMD Manufacturers : Article 46(g) Wholesalers: Article 80(i) Directive 2001/83, as amended Revised EU GDPs Paragraphs 5.11, 6.3- obligations Paragraphs defined procedures Slide 10

11 UK: Case 2 Falsified Truvada & Viread Contributory Factors 1. Responsible Person Suitability 2. Knowledge & Understanding of Regulatory Requirements Slide 11

12 RP Suitability Revision of EU GDPs/ Chapter 2 Personnel- General Issues More detailed requirements for RPs & other personnel; Specific emphasis on personnel being competent to perform their roles; More detailed requirements for definition of roles and responsibilities; Need for ensuring adequate availability of resource; More detailed training requirements; Includes scope for assessment by authorities of the adequacy of personnel based on risk. Slide 12

13 RP Suitability Revision of EU GDPs/ Chapter 2 Personnel the RP Key Factors Qualifications have to be appropriate to the level of responsibility Scope to consider the level of qualification of the RP in the context of risk & complexity of the operation Highlights the primary function of the RP is to ensure compliance with legislation Slide 13

14 RP Suitability Revision of EU GDPs/ Chapter 2 Personnel the RP Detailed Responsibilities 12 listed areas of responsibility Responsibility for performing the qualification & approval of suppliers Responsibility for contract approval Slide 14

15 Third Country Importation Third Country Importation from Bulgaria factor in Truvada & Viread case Revised EU GDPs/ Chapter 5- Operations Includes the need for distributors receiving medicinal products from third countries to hold a manufacturing/ import authorisation. Includes products imported for the purpose of exportation Slide 15

16 Safety Features Safety Feature Requirements: Falsified Medicines Directive Longer term solution to be implemented from 2017 Provide verification of product authenticity through unique identification feature Provide full track, trace history Slide 16

17 FMD & Revised EU GDPs Burden Benefits Patient Safety Slide 17

18 Follow Up Questions For further information: Slide 18