Regulators in both established and maturing agencies are facing challenges in their effort to provide...
At the European Council of Ministers meeting in Sofia, Bulgaria, UK Prime Minister Theresa May made it clear that the UK will be leaving the EU Customs Union (EUCU) and as such will need to negotiate special arrangements with the European Commission (EC) for access to the European free market.
In a meeting of industry stakeholders and the Europeans Medicines Agency (EMA) held on the 23 May, attendees were informed that unless a draft withdrawal agreement was agreed by Council of Ministers meeting planned for November 2018, then the 20-month transitional period would not be sanctioned, and that as from 30 March 2019 the UK would become a third country to the EU.
The EC expressed concern that: “Many marketing authorisation holders have not yet taken the necessary regulatory actions, such as marketing authorisations transfers, relocation of QPPV. While recognising the complexity of some of these procedures for companies to put in motion, there seems to be also a ‘wait and see’ approach by the MAHs. Communication with companies needs, therefore, to be continued and enhanced reminding them of their responsibility to act swiftly, considering as the baseline for preparedness the withdrawal date of 30 March 2019, in order to avoid disruption in the supply of medicines.”
The EMA pointed out that UK companies need to consider the timely process adaptations and changes for marketing authorisation holders (MAH) such as:
- MAHs need to be established in the EU / European Economic Area (EEA)
- Both the qualified person (QP) for batch certification and the QP for Pharmacovigilance (QPPV) need to reside and carry out their tasks in the EU/EEA
- The site for batch testing and release needs to be located in the EU/EEA
In addition, good manufacturing practice (GMP) certificates issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) will only be able to be used as ‘supporting information’ in risk-based inspection planning after Brexit, and UK companies wishing to export their products to Europe will require having their products tested, and if found satisfactory certified for release, within an EU member state.
On 23 January 2018, EMA launched a survey to gather information from MAHs of centrally authorised medicines that are located in the UK; have quality control, batch release or import manufacturing sites in the UK; or have a QPPV or pharmacovigilance system master file (PSMF) in the UK on their plans to submit transfers, notifications or variations to their marketing authorisations in preparation for Brexit.
The report identifies:
- The European Federation of Pharmaceutical Industries and Associations (EFPIA) estimate that more than 2,600 products are manufactured at some stage during production in the UK. To date, there is only evidence of 370 that are centrally registered and have started the registration process to be marketed in Europe
- Of the 1165 human medicinal products registered centrally with the European Medicines Agency (EMA), 427 have been registered by a UK-based MAH and 323 utilise UK QPPV services
- Of the 215 veterinary medicinal products registered centrally with the EMA, 24 have been registered by a UK-based MAH and 323 utilise UK QPPV services
- On 11 April, EMA announced that more than 370 centrally authorised products had been transferred to new rapporteur and co-rapporteur authorities in the respective EU and EEA member states
- To date, no mention is made of products resisted in individual member states by the decentralised procedure
Please contact PharmaConsult Global:
- To provide help to those UK or EU-based companies that have not yet stared to take action to avoid possible medicines supply issues that might result in shortages of medicines
- To help organisations to start planning for any regulatory steps required for their centrally authorised products to remain on the EU market post-Brexit in order to minimise disruption to medicines supply and avoid shortages
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