Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, which EU (a) legislative and (b) other proposals his Department is leading negotiations on for the Government in the Council of the EU.

With regards to transposition, the Department is currently finalising the following:

― European Qualifications (Health and Social Care Professions) Regulations 2016, which will transpose the relevant sections of the revised Mutual Recognition of Professional Qualifications Directive into the healthcare regulators’ governing legislation;

― Commission Implementing Decision (EU) 2016/787 and certain aspects of the Tobacco Products Directive 2014/40/EU;

― Commission Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells;

― Commission Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells; and

― Elements of the Falsified Medicines Directive 2011/62/EU (safety feature elements).

With regards to negotiations, the Department is currently leading on:

― Regulations on Medical Devices and In Vitro Diagnostics; and

― Amendments to Regulation No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.