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<br /><p>In the years indicated, the Department has introduced the following regulations,
either wholly or partially, as a result of European Union legislation:</p><p>2013</p><p><strong></strong></p><p>-
Statutory Instruments 2013/1855 and 2013/2593 concerning the regulation of medicines.</p><p>-
Statutory Instrument 2013/2327 concerning the regulation of medical devices.</p><p>-
National Health Service (Cross-Border Healthcare) Regulations 2013 (SI 2013/2269).</p><p>-
The Infant Formula and Follow-on Formula (England) (Amendment) Regulations 2013 (SI
2013/3243).</p><p>- Medical Profession (Responsible Officers) (Amendment) Regulations
2013.</p><p><strong></strong></p><p><strong></strong></p><p>2014</p><p><strong></strong></p><p>-
Statutory Instrument 2014/490 concerning the regulation of medicines.</p><p>- Quality
and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014 (SI
2014/1459).</p><p>- Health Care and Associated Professions (Indemnity Arrangements)
Order 2014 (Order 2014/1887).</p><p>- The Human Tissue (Quality and Safety for Human
Application) (Amendment) Regulations 2014 (SI 2014/2883).</p><p>- The Human Fertilisation
and Embryology (Quality and Safety) Regulations 2014 (SI 2014/2884).</p><p>- General
Medical Council (Fitness to Practise) (Amendment) Rules Order of Council 2014.</p><p>-
General Medical Council (Licence to Practise and Revalidation) (Amendment) Regulations
Order of Council 2014.</p><p>- General Medical Council (Restoration following Administrative
Erasure) (Amendment) Regulations Order of Council 2014.</p><p>- General Medical Council
(Voluntary Erasure and Restoration following Voluntary Erasure) (Amendment) Regulations
Order of Council 2014.</p><p>- Medical Act 1983 (Amendment) (Knowledge of English)
Order 2014.</p><p>- The Human Medicines (Amendment) Regulations 2014.</p><p><strong></strong></p><p><strong></strong></p><p>2015
to date:</p><p><strong></strong></p><p>- National Health Service (Cross-Border Healthcare)
(Amendment) Regulations 2015 (SI 2015/139).</p><p>- General Chiropractic Council (Indemnity
Arrangements) Rules Order of Council 2015.</p><p>- General Osteopathic Council (Indemnity
Arrangements) Rules Order of Council 2015.</p><p>- General Medical Council (Fitness
to Practise and Over-arching Objective) and the Professional Standards Authority for
Health and Social Care (References to Court) Order 2015.</p><p>- Health Care and Associated
Professions (Knowledge of English) Order 2015.</p><p>- Health Care and Associated
Professions (Knowledge of English) Order 2015 (Commencement No 1) Order of Council
2015.</p><br /> <br /><p>In the years indicated, the Department expects to implement
the following regulations as a as a result of EU legislation:</p><p><strong></strong></p><p>2016</p><br
/><p>- The Human Fertilisation and Embryology (Quality and Safety) Regulations 2016.</p><p>-
The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations
2016.</p><p>- Regulation (EU) 609/2013, concerning detailed requirements as to the
composition of certain specific types of food (infant and follow-on formula; processed
cereal-based foods and baby foods; foods for special medical purposes; and total diet
replacement for weight control), and the nutritional information that must be provided
in respect of such foods.</p><p>- The European Qualification (Health and Social Care
Professions) Regulations 2016.</p><p>- The Tobacco and Related Products Regulations
2016.</p><br /><p>2017</p><br /><p>- Regulations implementing the EU Regulation on
Clinical Trials and Regulations implementing the two EU Regulations on Medical Devices
and In-vitro Medical Devices.</p><br /><p>When the Department makes regulations that
transpose EU legislation, it follows the guidance and framework set by the Better
Regulation Executive. This requires the Department to prepare and publish an impact
assessment only when the net costs to business are greater than £1 million per year.
These would be laid with associated regulations and explanatory memorandum.</p><p><strong></strong></p><p><strong></strong></p>
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