Other News

Industry plans for disruption amid Brexit uncertainty

With the EMA's relocation to Amsterdam showing no signs of becoming painless, the European Parliament’s health committee has signaled its intention to review the governance of agencies as an opportunity to ensure it plays an active role in future decisions. This stance has come from members of the Committee on the Environment, Public Health and Food Safety (ENVI) and is a direct result of grievances over the handling of the relocation of the European Medicines Agency (EMA).

ENVI has identified an opportunity to ensure that the European Parliament not be shut out of decisions relating to European Union agencies in the future. In light of governance challenges related to the EMA and other EU agencies, another parliamentary committee is preparing a report that will look into political oversight of arm’s-length institutions. ENVI wants to get its views on the EMA’s move into the report. With the EMA's situation and capability to manage the impact of losing the MHRA post-Brexit looking increasingly perilous, the United Kingdom health minister has dismissed rumors that the government has asked the drug industry to stockpile 20 weeks' worth of medicines as a result of FMD and Brexit. However, in a separate exchange, another minister left the door open to the extension of the government’s current request for a six-week stockpile. It is unclear whether the UK could resolve a breakdown of trade with the EU within six weeks, and it has recently emerged that the industry is unsure how the government came up with the six-week figure.

With preparations for a no-deal Brexit still continuing in earnest despite the recent positive rhetoric from both sides, the former EU Brexit secretary Dominic Raab was quoted as saying that “government and the pharmaceutical industry already liaise on stockpiling for far longer periods in other circumstances, including in relation to vaccines. This is something the industry is used to doing and we are used to cooperating with it.” However, the primary concern from the industry leaders is that the UK lacks the cold-chain capacity to meet the request for a six-week stockpile - not to speak of storage capacity for a 20-week stock pile for all medicines - and that the system will simply collapse under the weight of such movement of goods. The UK government is working to bring additional cold-chain capacity online, but there are doubts about whether it will have the space to store six weeks of temperature-sensitive products by the time the UK leaves the EU in March 2019.

Meanwhile, the EMA has stated that marketing authorisation holders (MAHs) that submit Brexit-related type IA variation filings in December will receive acknowledgements of the validity of submissions within 30 days. The time frame is the standard response window for minor, type IA variation submissions. MAHs can make type IA variations and then inform the EMA of their actions, either immediately or within 12 months depending on the nature of the revision. Type IA changes cover some of the modifications necessitated by Brexit - such as updates to the names of manufacturers - and, in the past, the EMA has said that notifications related to the UK-EU split must be filed by late May 2019.

While the EMA is sticking to its standard timeline for Brexit-related notifications, filings about other variations may take longer to process. The EMA is encouraging MAHs to submit type IA notifications by the end of November 2018. The agency will acknowledge the validity of these submissions before it closes for Christmas on 21 December.

Please let us know any comments you have on this article:

Also see our

press coverage

News Index

11 Feb 2019

Garth Hedenskog joins ELC Group to expand global sales

26 Nov 2018

Industry plans for disruption amid Brexit uncertainty

25 Oct 2018

ELC Group at 5th Nordic Pharmacovigilance Day - Oct 24th, Copenhagen

05 Oct 2018

EU/US MRA - Brief overview and update

21 Aug 2018

Brexit - has the music stopped?

13 Jul 2018

Recent EMA Brexit Survey

15 Jun 2018

The EMA: 100 not out

08 May 2018

MHRA sets its post-Brexit strategic direction

12 Apr 2018

Brexit - Stick or Twist?

20 Mar 2018

Clinical Trials: all change 2019

22 Jan 2018

Orphan Medicines: almost 20 years on

15 Dec 2017

Update on Brexit developments

05 Oct 2017

How recent moves by the FDA spell good news for generics in the US

11 Sep 2017

Medicines for the Elderly – is your drug development strategy up to the mark?

14 Aug 2017

The MNAT initiative – what’s new?

19 Jul 2017

ICH Q12: Light at the end of the tunnel…?

05 Jun 2017

Q3D: Are your established products in compliance?

02 Jun 2017

Key pharmacovigilance trends to watch

08 May 2017

EMA updates guidance on PSURs

10 Apr 2017

New EMA Consultation on the Quality of Inhaled Pharmaceutical Products

16 Mar 2017

European Parliament’s adoption of ‘Options for improving access to medicines’ procedure

16 Feb 2017

Article 58: a hidden potential

24 Jan 2017

Global lifesciences partner ELC Group teams with PSR Group for advanced drug development

19 Jan 2017

A positive step forward for Biosimilar registration

20 Dec 2016

Falsified Medicines Directive – Are you making the right preparations?

21 Nov 2016

New Public consultation launched by the European Commission (EC)

19 Oct 2016

Transatlantic collaboration to boost research and development of medicines for rare diseases

03 Jun 2016

ELC Group to showcase regulatory affairs solutions at CPhI events in Shanghai and Barcelona

16 Jun 2015

ELC Group in early-stage development of novel influenza vaccine

09 Jun 2015

ELC Group expands into pharmaceutical product development market

21 Apr 2015

ELC Group signs 1.5 million Euro regulatory affairs contract with Chinese pharma giant

24 Feb 2015

Fast-growing regulatory affairs service provider ELC Group expands corporate presence in Czech Republic

02 Feb 2015

ELC GROUP to present at “Regulatory & Legal Affairs in Russia 2015” Conference

15 Sep 2014

Pharma eReport delivers V5-compliant solution to help MAHs meet December 31st XEVMPD resubmission deadline

20 Aug 2014

ELC Group Appoints Dr. Siddharth Chachad as Head of Global Clinical Development and Medical Affairs

28 Jul 2014

ELC Group Appoints Head of Regulatory Affairs for Russia and CIS

14 Apr 2014

Global regulatory affairs specialist ELC Group appoints Localization Business Development Manager for new US Office

10 Oct 2013

Global regulatory affairs specialist ELC Group accelerates international expansion plans following 25% revenue growth in 2013

17 Sep 2013

Global regulatory affairs specialist ELC Group appoints former MHRA Expert Medical Assessor

23 Apr 2013

Global regulatory affairs specialist ELC Group receives accreditation to provide readability testing in Romania

27 Feb 2013

Global regulatory affairs specialist ELC Group to deliver pharmaceutical training event in Latvia

20 Feb 2013

Global pharmaceutical regulatory affairs specialist ELC Group launches Clinical Trials services

10 Jan 2013

Global pharmaceutical regulatory affairs specialist ELC Group hosts International Training Seminar in Mumbai, India

31 Dec 2012

2012 Events

07 Nov 2012

Global pharmaceutical regulatory affairs specialist ELC Group establishes new office in Singapore

22 Aug 2012

Global pharmaceutical regulatory affairs specialist ELC Group increases operational support in Ahmedabad

12 Jun 2012

XEVMPD software provider Pharma eReport launches Excel Data Import Service

06 Jun 2012

ELC Group partners with mdi Europa GmbH to offer end-to-end regulatory solution for medical device companies in Europe

28 Mar 2012

ELC Group joins DIA EuroMeeting in Copenhagen

21 Mar 2012

EVMPD software provider Pharma eReport announces full general availability of Centrality XEVMPD compliance solution

08 Mar 2012

ELC Group Hosts Successful International Regulatory Seminar

06 Mar 2012

Pharmaceutical regulatory affairs specialist ELC Group opens new office in Mumbai

23 Feb 2012

Regulatory challenges for 2012 and their impact on marketing authorisation

21 Feb 2012

ELC Group launches new software subsidiary Pharma eReport to provide complete EVMPD compliance solution

08 Feb 2012

Pharmaceutical regulatory affairs specialist ELC Group establishes global HQ in Cambridge, UK

07 Dec 2011

Past president of TOPRA and ELC GROUP Advisor speaks at International Regulatory Seminar in Ahmedabad 23 February 2012

27 Sep 2011

ELC GROUP Advisory Board’s Dr. Paolo Biffignandi to write opinion column for industry leading publication

12 Jul 2011

ELC Group aim to foster strategic and economic ties within India and China

25 May 2011

ELC Group announces doubled revenues

11 May 2011

ELC Group appoints former TOPRA President