MAH Responsibilities and the Role of the QP

MAH Responsibilities and the Role of the QP QP Forum 12 th April 2018 Ann Mc. Gee Managing Director Pharmalex Ireland © Pharma. Lex

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MAH Responsibilities and the Role of the QP Who is the Marketing Authorisation Holder (MAH)? • • The Company or other legal entity in whose name the Marketing Authorisation has been granted Typically a legal entity with no organisational structure Often the MAH is the Regulatory function of an affiliate MAH responsibilities cannot be delegated. Activities can be delegated but still require oversight by the MAH What does all this mean? Who takes responsibility for what? Role of QP? ? © Pharma. Lex How many MAHs have a structured QMS, for example a structured change management system? 6

MAH Responsibilities and the Role of the QP QP What is the level of QP in organisation? Are they involved in decision making? Who do they report to? © Pharma. Lex Have they got the required visibility? Are they kept informed of MA variations? Do they have input into significant change controls; new product introduction? 7

MAH Responsibilities and the Role of the QP 10. Control of responsible Marketing and Promotion Role of the QP? ? 9. Provision of Medical information 1. Control of Clinical Trials / Studies (pre and post marketing 2. Oversight of manufacturing from API to QP release to market Legal Obligations of Marketing Authorisation Holder (EU) 3. QP Arrangements Related activities may be delegated but responsibility is retained by MAH 8. Pharmacovigilance & QPPV 4. Control of Labelling and Packaging 7. Complaints, Quality Defects and Recall 5. Supply and Distribution 6. RP Arrangements © Pharma. Lex 8

MAH Responsibilities and the Role of the QP 1. Control of Clinical Trials / Studies (pre and post marketing MAH Responsible for ethical clinical trial design and execution Clinical trials/studies must be managed in compliance with GCP Considerations for the QP • What clinical trials is the organisation conducting? • QP review of batch record • Release of batch according to Annex 13 © Pharma. Lex 9

MAH Responsibilities and the Role of the QP 2. Oversight of manufacturing from API to QP release to market MAH Oversight of the supply chain to ensure medicinal products are manufactured and distributed in accordance with GMP and GDP and to ensure that falsified medicines are prevented from entering the supply chain Eudra. Lex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release © Pharma. Lex 10

MAH Responsibilities and the Role of the QP © Pharma. Lex 11

MAH Responsibilities and the Role of the QP QP – review of the documented supply chain Who are the stakeholders in supply chain? What about physical transport considerations? What about storage considerations? What about product ownership? What about financial transactions? What about compliance status? How can the QP gain assurance? • • • Knowledge of control of supply chain Vendor qualification and management Quality agreements with stakeholders External audits Change management © Pharma. Lex 12

MAH Responsibilities and the Role of the QP 3. QP Arrangements MAH • • Provision of a QP QP as the eyes and ears of the MAH & structures to enable this to operate Considerations • • • Multiple QPs in the chain QP at a CMO QP to QP agreements How to ensure that Contract QPs are kept current? Is the QP satisfied that they have connections with the right people – RP, QPPV? © Pharma. Lex 13

MAH Responsibilities and the Role of the QP 4. Control of Labelling and Packaging MAH • • • Must be current and correct Liaison between MAH and manufacturing/batch release sites Regular review of finished packs from batch release sites Incorrect labelling is the source of many product recalls • How is the QP kept up-to-date on current labelling? • Is QP involved in change management process? • Does the QP have a relationship with Regulatory Affairs? © Pharma. Lex 14

MAH Responsibilities and the Role of the QP 5. Supply & Distribution 6. RP Arrangements MAH • • • GDP requirements Management and control of procuring, supply, distribution, storage, transportation RP roles & responsibilities QP © Pharma. Lex RP 15

MAH Responsibilities and the Role of the QP 7. Complaints, Quality Defects & Recall MAH 8. Pharmacovigilance & QPPV • • • QPPV appointed by MAH Involvement of Ph. V function? Reporting requirements to authorities Relationships QP QPPV RP QP How are these relationships built and maintained? What is the level of trust? © Pharma. Lex 16

MAH Responsibilities and the Role of the QP Contracted activities MAH must ensure an appropriate standard of quality and compliance exists at third party organisations Activities may include: • Manufacturing & distribution • Logistics • Testing and QP release of manufactured product WHERE DOES • Pharmacovigilance services THE QP COME • Regulatory affairs services • Management of safety information INTO THIS? ? • Supply chain services • Contract clinical trial/GCP services • Representatives in local markets receiving and forwarding product quality complaints and ADR reports • Complaint coordination and investigation at contract manufacturing/distribution sites • Recall management at contract manufacturing/distribution sites © Pharma. Lex 17

Ms. Ann Mc. Gee +353 1 846 4742 Ann. mcgee@pharmalex. com Suite 2 Stafford House Strand Road Portmarnock Co Dubllin D 13 H 525 All content is based on the current science and best practices and is subject to change. This document is property of the Pharma. Lex Group and is intended for the client only. Unauthorized use, disclosure, or copying of the information contained in this document is prohibited. © Pharma. Lex 18

9. Provision of Medical Information MAH © Pharma. Lex • • Medical Information function Establish a scientific service to compile and collate all information relating to product 20

Back-up slide • • H MA 10. Control of responsible Marketing & Promotion • • MAH MA • Activities to be conducted in compliance with IPHA Code of Practice and SI 541 (Control of Advertising) Training in these codes/regulations required for relevant personnel Promotional materials Procedures to manage development, approval, distribution, update Ensure only current promotional materials and Sm. PCs are provided to HCPs H • • © Pharma. Lex Management and control of free medical samples Training for Sales Reps regarding product information, complaint and adverse reactions report handling 21