FCO statement on North Korea missile test launches

Following missile test launches by North Korea on 24 July we continue to closely monitor the situation.

We encourage North Korea to return to talks with the US as agreed at the meeting between President Trump and Kim Jong Un on 30 June. We maintain that North Korea must engage in meaningful negotiations with the US and take concrete steps towards complete, verifiable and irreversible denuclearisation.

The UK fully supports the US in its efforts to achieve North Korean denuclearisation. International sanctions must remain in place and be fully enforced until their nuclear and ballistic missile programmes are dismantled.




Contingency legislation covering regulation of medicines and medical devices in a no deal scenario

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Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no-deal scenario.

Contingency legislation is needed in order for the Medicines and Healthcare products Regulatory Agency (MHRA) to be able to take on regulatory processes for human medicines and devices that are currently undertaken by the European Medicines Agency and other bodies.

The three separate pieces of legislation will allow for the continued sale of, and access to, medicines, medical devices and clinical trials:

  1. Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc) (EU Exit) Regulations 2019
  2. The Medical Devices (amendment) (EU exit) Regulations 2019
  3. The Medicines for Human Use (Clinical Trials) (amendment) (EU exit) Regulations 2019

These Regulations have been approved by Parliament and were made in April 2019.

The Human Medicines and Medical Devices (Amendment etc.) (EU exit) Regulations 2019 have been laid in parliament today (24 July 2019).

This instrument makes a number of changes to the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 and the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 to ensure that the UK legislation accurately reflects technical updates at EU level since April 2019 and also corrects drafting errors and omissions to reflect published policy in the event of a no deal Brexit.

Full details of the changes are set out in the explanatory memorandum.

The legislation will be subject to parliamentary scrutiny and approval which we anticipate in the autumn.

These Regulations set out a comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance.

They also provide for enforcement powers for the authorisation and supervision of medicinal products for human use.

The 2012 Regulations (as amended by the 2019 Regulations) make reference to various pieces of EU guidance, as that stood immediately before exit day (29 March 2019).

The Agency is the designated competent authority that administers and enforces the law on medical devices in the UK. It has a range of investigatory and enforcement powers to ensure their safety and quality. These regulations ensure that the required powers are provided for.

The Clinical Trial Regulations require all interventional clinical trials of medicines to be authorised by the MHRA, as the national competent authority in the UK; to have a favourable ethics opinion; and to be conducted according to Good Clinical Practice. They also include requirements for the assessment and supply of investigational medicinal products and for safety reporting.

Published 24 January 2019
Last updated 9 October 2019 + show all updates

  1. Change of text within Stay up to date box.
  2. We have updated references to the Human Medicines and Medical Devices (Amendment etc.) (EU exit) Regulations 2019, following it being laid in Parliament on 24 July 2019.
  3. First published.



Making UK manufacturing smarter: apply for funding

Industrial digital technologies driven by artificial intelligence, robotics and the Internet of Things have the potential to significantly increase the productivity of UK manufacturing.

The Made Smarter Review 2017 commissioned by the UK government estimated that industrial digitalisation could increase productivity by more than 25%.

The UK government’s Industrial Strategy Challenge Fund Manufacturing Made Smarter Challenge aims to raise productivity by 30% by 2030 by investing in projects that support industrial digitalisation.

The Industrial Strategy Challenge Fund (ISCF) has up to £30 million to invest in projects that use industrial digital technologies to transform manufacturing productivity.

Projects must aim for short-term impact

The competition aims to support projects that can achieve short-term impact and rapid technology development through industrial digitalisation across a range of sectors from aerospace to food and drink and pharma.

Projects can be led by any sector but must show how they could be applied to at least 2 other sectors.

They should fit into one of 4 themes:

  • smart, connected factory, including use of real-time data to optimise efficiency and capture, analysis and visualisation of manufacturing processes
  • connected and versatile supply chain, including information integration, communication, traceability and trust
  • design, make, test, including transforming product design through digital technologies and virtual product testing, verification and modelling, quality monitoring and inspection
  • adaptable flexible manufacturing operations and skills, including culture change and skills development, and human-centric automation and autonomy

Competition information

  • the competition is open, and the deadline for applications is at midday on 21 August 2019
  • businesses of any size may apply
  • we expect projects to range in size between £250,000 and £10 million
  • a briefing event will be held on 30 July 2019



How GAD helped when staff transferred to Defra

The Government Actuary’s Department (GAD) provided advice and assistance when around 1,000 Environment Agency staff transferred to the Department for Environment, Food and Rural Affairs (Defra) in November 2017. The transfer took place because the corporate services functions of both organisations were being centralised in Defra.

This transfer was covered by the Cabinet Office policy on staff transfers in the public sector. This policy protects pension arrangements for people who are compulsorily transferred to other public sector employers.

Future benefits

GAD advised Defra on several, complex areas around the pension provision transfer to make sure that members’ future benefits were protected. We carried out an assessment confirming the new pension arrangements were ‘broadly comparable’ to those available to staff before the transfer. We helped ensure that people involved in the transfer were kept up to date about their future pension arrangements by supplying information for written communications and input for webinars.

Past benefits

We advised Defra on the benefits the members would receive in the Civil Service pension arrangements if they decided to take part in a bulk transfer exercise and helped support further webinars. We advised Defra on the financial implications of the transfer to them. Once the bulk transfer options were completed, we provided further support and calculations to Defra, Cabinet Office and HM Treasury.

Communications and information

GAD staff transfer experts also provided information which was included in the member option packs. These packs gave people the opportunity to transfer their past pension benefits under the bulk transfer arrangement. They included an information pack and Q&A document informing the members of their bulk transfer option.




East London crook charged with meds crimes

Mile End man sent down for involvement in the illegal supply and sale of potentially dangerous unauthorised and prescription-only medicines and Class C drugs.

Published 25 July 2019 From: Medicines and Healthcare products Regulatory Agency

Leonard Cosgrove, 56, was yesterday sentenced to 2 years and 9 months after being found guilty of conspiracy to supply unauthorised medicinal products, the supply of prescription only medicines and Class C drugs.

Yesterday’s sentencing follows an in-depth investigation by enforcement officers from the Medicines and Healthcare products Regulatory Agency (MHRA) into a network suspected to be involved in the illegal importation and supply of medicines such as Tadalafil, Sibutramine, and Sildenafil.

Supplying medicines from sources outside the regulated supply chain represents a significant public health risk as they may contain dangerous ingredients that can have devastating consequences for the people who use them. As such the criminal group responsible showed a complete disregard for the public’s safety and well-being.

Tariq Sarwar, MHRA Head of Operations, said of the conviction:

“Our message is clear: illegally supplying prescription only and unlicensed medicines and Class C drugs is a serious criminal offence.

“Medicines sold this way cannot be guaranteed to be safe and can present a real risk to public health. Some may contain dangerous ingredients that can have devastating consequences for the people who use them.

“Criminals selling medicines illegally show a blatant disregard for your health, and only care about making money. If you have any concerns about your health please contact a GP or a healthcare professional.”

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