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731066

registered interest
date	21/06/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	NHS: Drugs
house id	2
legislature	25277 pref label House of Lords
question text	Her Majesty's Government whether they plan to convert EU Regulation 658/2014 into UK law; and, if so, which UK body will assume the role of the European Medicines Agency for the setting and charging of fees to UK-based marketing authorisation holders.
tabling member printed	Baroness Hayter of Kentish Town
uin	HL74
answer	answer is ministerial correction date of answer 29/06/2017 answer text <p>The Medicines and Healthcare products Regulatory Agency sets and charges fees for marketing authorisations in the United Kingdom which are granted nationally and not approved centrally by the European Medicines Agency. The extent to which European Medicines Agency procedures will apply in the UK after we have exited the European Union will be subject to negotiations. The Government will ensure that the UK’s full approval regime is ready and operational as soon as the UK has formally departed the EU.</p> answering member printed Lord O'Shaughnessy question first answered 29/06/2017 11:37:19 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	4159 label Biography information for Baroness Hayter of Kentish Town

731067

registered interest
date	21/06/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
house id	2
legislature	25277 pref label House of Lords
question text	Her Majesty's Government whether they plan to convert EU Regulation 536/2014 into UK law; and, if so, whether the UK will continue to notify the EU Clinical Trial Portal of applications for clinical trials for medicinal products for human use, and retain full access to the Portal.
tabling member printed	Baroness Hayter of Kentish Town
uin	HL75
answer	answer is ministerial correction date of answer 29/06/2017 answer text <p>The Prime Minister has made clear that a key priority through the negotiations will be to ensure that the United Kingdom remains one of the best places in the world for science and innovation. As part of exit negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of clinical trials, including access to the EU portal and database.</p><p> </p><p>The UK applied sustained pressure to successfully reform the current Clinical Trials Directive in the best interests of patients and business and is planning for the new Clinical Trials Regulation to be brought onto our statute book. The timing of the application date of the new regulation is yet to be determined by the European Commission.</p> answering member printed Lord O'Shaughnessy question first answered 29/06/2017 11:38:11 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	4159 label Biography information for Baroness Hayter of Kentish Town