UKs withdrawal from the EU - preparedness activities update 14th - PowerPoint PPT Presentation

UK’s withdrawal from the EU - preparedness activities update 14th industry stakeholder platform – operation of EU pharmacovigilance - 28 September 2018 Presented by Marie-Helene Pinheiro, EMA Industry Liaison Claudia Galeazzo , Head of Service – Products and Applications Business Support European Medicines Agency An agency of the European Union

Agenda EMA Operational preparedness  EMA Business Continuity Planning Phase 3 Relocation Operational preparedness preparedness  UK Portfolio re-distribution implementation status update  EMAA Industry CAPs Brexit Survey Analysis and Follow-up Human resource Communication preparedness preparedness  PhV Fees invoicing update 1 UK’s withdrawal from the EU - preparedness activities update

1 - EMA Business Continuity Planning EMA Brexit Preparedness BCP in a nutshell • The aim of the EMA Brexit Preparedness BCP is to address a situation where a “business as usual” scenario is no longer possible – Either because EMA has to ensure that the necessary human resources are available to work on EMA Brexit preparedness – Or because EMA can no longer compensate staff loss through the recruitment of replacement resource • Both situations can exist in parallel and may persist for a longer period • To operate the EMA Brexit Preparedness BCP, EMA activities have been grouped in 3 categories which can broadly be described as follows: Category Activities covered Category 1 (highest priority) Core scientific activities and supporting IT applications, activities corporate/ communication/ other IT activities necessary for EMA’s operation, legal obligations put on EMA Category 2 (medium priority) Either strategic activities or other core activities, sub-classified into 2A and activities 2B Category 3 (lowest priority) Non-strategic activities such as governance and support activities activities 2

1 - EMA Business Continuity Planning 3 UK’s withdrawal from the EU - preparedness activities update

2 – EMA Preparedness context EC and EMA published a Notice to MAHs of centrally authorised medicines products for human and veterinary use 2 nd May 2017 Companies reminded to plan in advance in order to avoid any im pact on the continuous supply of m edicines for human and veterinary use within the Union (EEA). 4 Further details can be seen in the European Commission presentation from the 24/ 9/ 18 – See EMA webpage events

3 - EMA Com m ittees Operational Preparedness Implementation of the redistribution of the UK centrally authorised products portfolio (1/ 3) • The redistribution of the UK product portfolio * was finalised on 4 April 2018 and the new ( Co) -Rapporteurships w ere com m unicated to the MAHs on 3 0 April 2 0 1 8 • The new ( Co) -Rapporteurs will only take full responsibility for the re-allocated medicinal products as of 3 0 March 2 0 1 9 w hen the UK w ithdraw s from the Union and becomes a third country. The MHRA/ VMD will be accountable for the medicinal products for which they are (Co)-Rapporteurs until 29 March 2019 • However, the new (Co)-Rapporteurs may be required to handle, from Q4 2 0 1 8 onw ards , post-authorisation procedures when it is envisaged that the procedures may be still under evaluation after the 3 0 of March 2 0 1 9 • The decision is taken at procedure level and depending on the average length of the procedure 5

3 - EMA Com m ittees Operational Preparedness Implementation of the redistribution of the UK centrally authorised products portfolio (2/ 3) For lines extensions and extensions of indication the cut-off dates have already • surpassed and therefore all procedures starting after 1 October 2 0 1 8 will be allocated to the new (Co)-Rapporteurs. • Quality, safety and efficacy type I I variations will be allocated to the new (Co)- Rapporteurs if submitted after 2 6 October 2 0 1 8 and renew als submitted after 2 4 October 2 0 1 8 will also be allocated to the new (Co)-Rapporteurs • PSURs ( CAPS only) submitted after 6 Novem ber 2 0 1 8 will already be handled by the new (Co)-Rapporteurs • Type I B variations submitted after 1 6 January 2 0 1 9 will be allocated to the new (Co)- Rapporteurs 6

3 - EMA Com m ittees Operational Preparedness Implementation of the redistribution of the UK centrally authorised products portfolio (3/ 3) 2 0 1 8 2 0 1 9 Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Type II Type II Line ext. Opinion Opinion UK Opinion UK Lead Rapporteur Formal activation New delegation ‘Shadow’ Rapporteur New delegation Lead Rapporteur Line New Type II ext. start MS start Line Type II ext. Opinion 7 Opinion

4 - EMA Brexit I ndustry Survey for CAPs update Timelines and Response rate Total sent UK involvem ent CAPs MAHs o 2 2 January 2 0 1 8 – The Industry survey was launched and sent to contact points for 694 CAPs corresponding to Hum an 6 6 1 1 6 7 176 MAHs. Veterinary 3 3 1 3 Total 6 9 4 1 8 0 o Industry survey was circulated to additional contact points for 4 CAPs (medicinal products that were authorised after cut-off date of October 2017) with a deadline for PSMF Human CAPs responses by 19 March 2018. • 3 6 0 CAPs have Pharmacovigilance System o The Industry survey received a 9 1 % response rate with Master File (PSMF) located in the UK and a grand total of 662 CAPs responses (both H and V). will change. Industry survey results - PSMF • Only 1 CAP has a PSMF located in the UK and QPPV response analysis and did not response to the question. (Human CAPs) • For 208 out of 360 CAPs, the new location is “Not known yet”. 8

4 - EMA Brexit I ndustry Survey for CAPs update Industry survey results - PSMF (Human CAPs) PSMF distribution Human CAPs MAHs PSMF planned timelines for the update of Article 57 220 200 70 Number of PSMF transfers 180 60 Number of PSMF transfers 160 140 50 120 40 100 80 30 60 40 20 20 10 0 Not know DE BE FR IE NL CY DK HR IT 0 Q1-2018 Q2-2018 Q3-2018 Q4-2018 Q1-2019 n yet Total 24 25 5 37 61 Total 208 89 44 5 5 5 1 1 1 1 9

4 - EMA Brexit I ndustry Survey for CAPs update Follow up with MAHs on “at risk” products 1 0 8 • Follow up meetings for 1 0 8 centralised m edicinal products were “at risk” m edicinal organised with 5 4 MAHs (45 Human and 9 Veterinary) products • A total of 51 teleconferences took place (43 Human and 8 Veterinary). A small number of MAHs provided information by email. • As seen from the feedback provided by MAHs, plans are changing for a number of companies since the launch of the survey and m any com panies w ill m ake the necessary changes before 3 0 March 2 0 1 9 . • 3 9 centralised m edicinal products (25 Human and 14 Veterinary) are 6 2 currently considered “at risk” and may have potential supply issues . • 6 Human products have been already withdrawn or will be withdrawn before 30 March 2019. 1 Veterinary product will not renew its Marketing 3 9 Authorisation. “at risk” m edicinal products 10

4 - EMA Brexit I ndustry Survey for CAPs update Tracking and monitoring of Brexit related changes  EMA has been and will continue to monitor and track the Non- Post- Authorised renewals authorisation products withdrawals procedures submissions of required changes for all 8 9 3 Brexit affected CAPs.  Currently 6 5 products have completed all the necessary changes in order to comply with the legal requirements. Total 8 9 3 Total medicinal medicinal Total products  products MAHs are rem inded of their legal obligations to medicinal 8 9 3 products 8 9 3 inform EMA on supply issues and product w ithdraw als.  Furthermore, MAHs are requested to tim ely inform EMA on Changes Ongoing pre- initial MAAs any changes to their current plans . approval 11

5 - EMA-EC Regulatory Guidances update Context: EMA-Industry Preparedness Activities EC-EMA Notice publication EMA Procedral guidance 2 nd May 2 0 1 7 follow ed by publication2 7 Novem ber 2 0 1 7 ,, EMA-EC Notice publication 3 1 st updated June 2 0 1 8 May 2 0 1 7 , updated June 2 0 1 8 UK’s withdrawal from the EU - preparedness activities update 12

5 - EMA-EC Regulatory Guidances update – PhV Specific 13 UK’s withdrawal from the EU - preparedness activities update

6 – Brexit related Pharmacovigilance fees update Impact and implementation of fees processing for: Pharmacovigilance Annual activities PSUR Pharmacovigilance referral PASS 14 Exclusion of UK on calculation of Pharmacovigilance fees Chargeable Units

6 – Brexit related Pharmacovigilance fees update 2019 Pharmacovigilance Annual fee implementation Advice note will be sent in April 2019 (instead of March) to all EU based QPPVs for EU NAPs products registered in Art.57 Exclusion of UK MA products and exclusion of UK QPPVs and UK MAHs (also for EU products) Invoice in July 2019 based on data as of 30/ 06/ 2019 covering the year, excluding UK MA products and UK MAHs (also for EU products) 15 Exclusion of UK on calculation of Pharmacovigilance fees Chargeable Units