News story: MHRA update to pharmaceutical companies on exit preparations

Update on negotiations

The European Council formally agreed on 15 December that sufficient progress has been made to move on to the second stage of the negotiations, and adopted guidelines for that second phase.

This followed the publication of a Joint Report on progress during the first phase by the Government and the European Commission on 8 December.

These are important steps forward for both sides and demonstrate the shared interest in managing our exit smoothly, and in moving on with our negotiations.

In the context of ensuring continuity in the availability of goods placed on the market under Union law before withdrawal, the Joint Report makes clear that “goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling; be put into service where provided in Union law, and that the goods concerned should be subject to continued oversight.”

The guidelines set out the need for the EU and the UK to complete work on all withdrawal issues and to start drafting the Withdrawal Agreement. The UK looks forward to continuing these discussions.

The EU guidelines also acknowledge the proposal put forward by the UK for a time-limited implementation period, based on the existing structure of EU rules and regulations. The aim is for access to one another’s markets to continue on current terms throughout this period, and for it to be based on the existing structure of EU rules and regulations.

Both parties have recognised the importance of such a period in the interests of providing certainty and continuity to businesses and individuals, and the EU is expected to adopt additional negotiating directives on transitional arrangements in January 2018. The UK expects to be able to rapidly agree the detail with the EU in 2018.

Finally, the guidelines reconfirm the EU’s desire to establish a close future partnership with the UK. As the UK enters the second phase of negotiations, its position on medicines regulation remains clear. The UK is fully committed to continuing the close working relationship with its European partners, in the interests of public health and safety. Its aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework and sharing of data.

Preparing for all outcomes

MHRA is aware that companies who market pharmaceuticals in the EU and UK will need to plan and make decisions in advance of the UK’s departure from the EU in March 2019.

As noted above, the UK’s intention remains to secure an implementation period based on the existing structure of EU rules and regulations as quickly as possible, and to agree a deep and special future partnership.

We will continue to advise businesses on the basis of the UK position and will continue to work with the European Medicines Agency in planning for the UK’s withdrawal from the EU and future relationship.

Current regulatory relationship between UK and European network

It is also important to note that the UK’s current regulatory relationship with the European network remains unchanged. The UK has underlined to Member States and to the EMA on several occasions that at present:

  • the UK continues to be a full member of the EU: we will fulfil our responsibilities, and, in turn expect to be treated as such.

  • the UK continues to bid for EMA work and expects its bids to be respected and considered on merit. There are simple, pragmatic solutions to manage the possibility of various outcomes in March 2019: we are, for example, putting forward UK bids in conjunction with other Member States, in the centralised procedure, to ensure business continuity where procedures are likely to run beyond this date.

  • MHRA have committed to complete all assessments under evaluation at the time that the UK departs from the EU and will make assessment reports available to the network.

  • the UK continues to carry out its Official Control Authority Batch Release (OCABR) responsibilities as part of the Official Medicines Control Laboratory (OMCL) network for human biologicals.

  • the UK will continue to put candidates forward for leadership roles where appropriate and expects the committees with responsibility for electing chairs to do so on merit.

UK regulatory requirements after March 2019 in the event of no ongoing relationship with EMA networks

Companies have been asking for detail about UK legislative requirements in different scenarios. We have been working closely with industry associations and other stakeholders and further details on all these issues and more – both our Day One and longer-term proposals – will be published when appropriate.

As stated above, the UK intends to agree a time-limited implementation period with the EU, and both parties have recognised its importance. Should however there be no implementation period, MHRA’s approach would be in line with the following principles:

  • the European Union (Withdrawal) Bill will convert the existing EU legislative framework into UK law at the moment of exit, so there would be no sudden changes to the UK regulatory framework.

  • we would be pragmatic in establishing UK regulatory requirements. We would give adequate notice and ensure that companies had sufficient time to implement any changed requirements.

  • where possible, we would be making use of the information we already have to complete administrative tasks for continuity of work and licences.

  • we would ensure the minimum disruption and burden on companies as the UK exits the EU, while building on the existing relationship between MHRA and firms.

We will continue to engage with business, patient groups and other stakeholders to help plan ahead with certainty, and will look to publish more technical detail if appropriate.




News story: New features for the UK House Price Index search tool and reports

We have added new functionality and data to the UK HPI search tool and monthly reports, to help users identify changing house price trends across the UK more easily. These changes are in response to feedback from customers.

With the new features of the search tool, you can:

  • compare average house prices in up to five separate locations across England, Scotland, Wales and Northern Ireland by county, region or local authority
  • type the location name, or click on the area on the map to select your location choice
  • get insight into market trend activity going back to 1968, by accessing historic data about the funding status, buyer status and property status information
  • present your search results as a table or graph
  • retrieve your search criteria at a later date, by bookmarking different stages of your search

When you have completed your search, you can download the data for the specific breakdown or all the data in the search results, in comma-separated (CSV) format. Linked data users can still explore the data further by accessing the SPARQL query behind the search.

We have added links in the published reports, so that users can download the data tables from the report itself in CSV format. This function benefits users who want to use the data without creating bespoke queries or accessing the full background files.

This change is part of the work being undertaken to improve our users’ experience of the UK HPI. Since its launch in June 2016, HM Land Registry and partners have started a programme of enhancements and updates. This has resulted in more available data, improved accuracy and extra commentaries in the reports.

In November 2017, the Office for Statistics Regulation confirmed the UK House Price Index will be awarded National Statistics status when some requirements are met. These enhancements fulfil an element of those requirements.

If you would like to share your feedback on the search tool or the UK HPI, you can register to join our LinkedIn UK HPI group or contact us for more information.




Press release: UK House Price Index for November 2017

The lowest number of repossession sales in September 2017 was in the East of England.

*Figures for the two most recent months are not being published because there are not enough new build transactions to give a meaningful result.

*Figures for the two most recent months are not being published because there are not enough new build transactions to give a meaningful result.

*Figures for the two most recent months are not being published because there are not enough new build transactions to give a meaningful result.

UK house prices grew by 5.1% in the year to November 2017, experiencing a 0.3 percentage point fall from the previous month.

The UK Property Transaction Statistics for November 2017 show that the number of seasonally adjusted transactions on residential properties with a value of £40,000 or greater rose by 7.1% in the year to November 2017. Between October 2017 and November 2017, transactions increased by 0.6%.

Looking at the regional level, the largest annual price growth was recorded in the West Midlands at 7.2%, up from 7.1% in October 2017. It was followed by the East Midlands at 6.4%. At 2.3%, both London and the North East region showed the slowest annual growth of all UK regions. This is the 12th consecutive month where the annual growth in London has remained below the UK average.

  • The UK House Price Index (HPI) is published on the second or third Tuesday of each month with Northern Ireland figures updated quarterly. The December 2017 UK HPI will be published at 9.30am on 13 February 2018. See calendar of release dates.

  • We have made some changes to improve the accuracy of the UK HPI. We are not publishing average price and percentage change for new builds and existing resold property as done previously because there are not currently enough new build transactions to provide a reliable result. This means that in this month’s UK HPI reports, new builds and existing resold property are reported in line with the sales volumes currently available.

  • The UK HPI revision period has been extended to 13 months, following a review of the revision policy (see calculating the UK HPI section 4.4). This ensures the data used is more comprehensive.

  • Sales volume data is also available by property status (new build and existing property) and funding status (cash and mortgage) in our downloadable data tables. Transactions involving the creation of a new register, such as new builds, are more complex and require more time to process. Read Revisions to the UK HPI data.

  • Revision tables have been introduced for England and Wales within the downloadable data. Tables will be available in csv format. See about the UK HPI for more information.

  • Data for the UK HPI is provided by HM Land Registry, Registers of Scotland, Land & Property Services/Northern Ireland Statistics and Research Agency and the Valuation Office Agency.

  • The UK HPI is calculated by the Office for National Statistics (ONS) and Land & Property Services/Northern Ireland Statistics and Research Agency. It applies a hedonic regression model that uses the various sources of data on property price, in particular, HM Land Registry’s Price Paid Dataset, and attributes to produce estimates of the change in house prices each month. Find out more about the methodology used from the ONS and Northern Ireland Statistics & Research Agency.

  • The UK Property Transaction statisticsare taken from HM Revenue and Customs (HMRC) monthly estimates of the number of residential and non-residential property transactions in the UK and its constituent countries. The number of property transactions in the UK is highly seasonal, with more activity in the summer months and less in the winter. This regular annual pattern can sometimes mask the underlying movements and trends in the data series so HMRC also presents the UK aggregate transaction figures on a seasonally adjusted basis. Adjustments are made for both the time of year and the construction of the calendar, including corrections for the position of Easter and the number of trading days in a particular month.

  • UK HPI seasonally adjusted series are calculated at regional and national levels only. See data tables.

  • The first estimate for new build average price (April 2016 report) was based on a small sample which can cause volatility. A three-month moving average has been applied to the latest estimate to remove some of this volatility.

  • Work has been taking place since 2014 to develop a single, official HPI that reflects the final transaction price for sales of residential property in the UK. Using the geometric mean, it covers purchases at market value for owner-occupation and buy-to-let, excluding those purchases not at market value (such as re-mortgages), where the ‘price’ represents a valuation.

  • Information on residential property transactions for England and Wales, collected as part of the official registration process, is provided by HM Land Registry for properties that are sold for full market value.

  • The HM Land Registry dataset contains the sale price of the property, the date when the sale was completed, full address details, the type of property (detached, semi-detached, terraced or flat), if it is a newly built property or an established residential building and a variable to indicate if the property has been purchased as a financed transaction (using a mortgage) or as a non-financed transaction (cash purchase).

  • Repossession sales data is based on the number of transactions lodged with HM Land Registry by lenders exercising their power of sale.

  • For England, this is shown as volumes of repossession sales recorded by Government Office Region. For Wales, there is a headline figure for the number of repossession sales recorded in Wales.

  • The data can be downloaded as a .csv file. Repossession data prior to April 2016 is not available. Find out more information about repossession sales.

  • Background tables of the raw and cleansed aggregated data, in Excel and CSV formats, are also published monthly although Northern Ireland is on a quarterly basis. They are available for free use and re-use under the Open Government Licence.

  • HM Land Registry’s mission is to guarantee and protect property rights in England and Wales.

  • HM Land Registry is a government department created in 1862. It operates as an executive agency and a trading fund and its running costs are covered by the fees paid by the users of its services. Its ambition is to become the world’s leading land registry for speed, simplicity and an open approach to data.

  • HM Land Registry safeguards land and property ownership worth in excess of £4 trillion, including around £1 trillion of mortgages. The Land Register contains more than 25 million titles showing evidence of ownership for some 85% of the land mass of England and Wales.

  • For further information about HM Land Registry visit www.gov.uk/land-registry.

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  • Press release: Change of Her Majesty’s Ambassador to Portugal in Summer 2018

    Mr Chris Sainty has been appointed Her Majesty’s Ambassador to the Portuguese Republic.

    Mr Chris Sainty has been appointed Her Majesty’s Ambassador to the Portuguese Republic in succession to Ms Kirsty Hayes. Mr Sainty will take up his appointment in summer 2018.

    CURRICULUM VITAE

    Full name: Christopher James Sainty

    Married to: Sarah Helen Sainty

    Children: Three

    2015 – 2017 FCO, European Correspondent and Head of Europe (South) Department, Europe Directorate

    2011 – 2015 Rome, Deputy Head of Mission

    2008 – 2010 Islamabad, Political Counsellor

    2006 – 2008 The Hague, Deputy Head of Mission

    2004 – 2006 FCO, Head of EU Presidency Department

    2000 – 2004 Madrid, First Secretary (Political)

    1998 – 2000 FCO, Head of Newsroom, Press Office

    1996 – 1998 FCO, Common Foreign and Security Policy Unit

    1992 – 1996 New Delhi, Second Secretary (Political)

    1990 – 1992 FCO, Hong Kong Department

    1989 Joined the Diplomatic Service

    Further information




    Press release: Winning design for 2015 Sousse and Bardo Memorial announced

    The ‘Infinite Wave’ by London and Gloucester-based George King Architects has been selected as the design for the memorial dedicated to the 31 British nationals who lost their lives, and to all of those affected by the two terrorist attacks in Tunisia in 2015.

    An independent panel shortlisted seven designs from 19 entries, and chose ‘Infinite Wave’ following consultation with family members of those affected by the two attacks.

    As announced last year, the sculpture will be located in Cannon Hill Park, Birmingham, and construction is due to be completed later on this year.

    The panel selected ‘Infinite Wave’ due to its beautiful flow and clever use of the natural environment, as well as positive feedback from family members.

    Announcing the winning design, FCO Minister for North Africa, Alistair Burt said:

    For those who lost loved ones or witnessed the horrendous terrorist attacks in Tunisia in 2015, resulting in 31 Britons being killed, their lives have never been the same since because of these cowardly acts of terror.

    I know several families have tried to ensure something good comes out of these terrible events, such as raising money for charity, or improving awareness of extremism in their community and they should be commended for their positivity.

    I hope that ‘Infinite Wave’ with its beautiful surroundings in Cannon Hill Park, will provide a focal point of tranquillity for families to reflect and remember their loved ones.

    Chair of the Creative Panel, Mark Castle, CEO, Victim Support, said:

    The panel were only too aware of the significant responsibility to find a design that is not only stunning to look at, but also one that families can connect with.

    We knew going into this process that we had a difficult task but the on-line design consultation with families revealed that George King’s concept resonated with many people affected by these terrible events.

    I think the appeal is not only because of the beautiful flow of the sculpture, and its clever use of the natural environment, but because the single tube of steel in George King’s concept shows how the people affected by these terrible events are intrinsically linked.

    Suzy Richards, who lost three members of her family in the attack said;

    I chose the infinity design because to me it represents never ending loss and pain of losing three generations of my family. My son Joel was just 19, my brother Adrian at 49, and my dad Pat, 79. It also represents our never ending love and beautiful memories we treasure.

    George King, Principal of George King Architects said:

    It is wonderful and overwhelming to be chosen to design this memorial. We put the families and their experiences very much at the heart of this concept and didn’t want to gloss over the immense pain they have been and continue to go through.

    We came up with ‘Infinite Wave’ to show how time stood still for victims on the day of the attacks and designed the surrounding landscape as a series of ripples.

    The ripples represent the impact that the events in Tunisia in 2015 had beyond those that lost their lives. They represent the survivors, the families of the victims, the local communities, the national heartache and the global loss.

    Cllr Lisa Trickett, Cabinet Member with responsibility for Parks at Birmingham City Council, said:

    I am pleased that the memory of those involved in these tragic events will be remembered in such a thoughtful way in Cannon Hill Park.

    This is an important Memorial and we believe the designers have paid respect to the beautiful park and that the successful design ‘Infinite wave’, will enhance the natural environment.

    We hope that, as well as providing a place of reflection for all of those affected by these horrific events, the site will also be appreciated and used by more regular park visitors.