Medicines Citation, commencement and interpretation 1 1 These Regulations may be cited as the Human Medicines (Amendment) Regulations 2014. 2 These Regulations come into force on 31st March 2014. Amendment of the Human Medicines Regulations 2012 2 The Human Medicines Regulations 2012 are amended as follows. Amendment of regulation 165 3 In regulation 165 (determination in other cases) after “medicinal product” insert “in relation to these Regulations”. Amendment of regulation 213 4 In regulation 213 (interpretation provisions for dealings with medicinal products)— a in paragraph (1)— i omit the definition of “controlled drug”, ii after the definition of “the dental care professionals register” insert— “Council Directive 2005/36/ EC ” means Council Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications ; iii For the definition of “ EEA health professional” substitute— “EEA health professional” means— a doctor of medicine, a nurse responsible for general care, a dental practitioner, a midwife or a pharmacist as those professionals are defined within the meaning of Council Directive 2005/36/EC ; a professional exercising activities in the health care sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC ; or a person of equivalent professional status to a health care professional within the meaning of regulation 8; ; iv omit the definition of “EEA prescription”; v after the definition of “prison service” insert— “product subject to special medical prescription” means a prescription only medicine that has been designated as subject to special medical prescription in accordance with paragraph (3); ; and b after paragraph (2) insert— 3 In this Part any substance or product for the time being specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations 2001 or in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations (Northern Ireland) 2002 is designated as a product subject to special medical prescription. Amendment of regulations 214, 217, 219, 224, 225, 240, 242 and 253 5 1 In the provisions listed in paragraph (2) for the words “controlled drug” substitute “product subject to special medical prescription”. 2 The listed provisions are— a 214(5)(a), (5A), (5B) and (6) b 217(3)(b); c 219(1); d 224(5); e 225(4)(b); f 240(5); g 242(1)(a) and (3)(a); h 253(5)(b)(ii). Insertion of regulation 217A 6 After regulation 217 (general requirements for prescriptions) insert— Requirements for prescriptions to be dispensed in an EEA state other than the UK 217A 1 In this regulation— “B” means a person who is an appropriate practitioner for the purposes of regulation 214(3) to (5B); “P” means a person who is the patient of B. 2 The information specified in paragraph (3) is to be included in any prescription where— a P requests a prescription that is to be dispensed in an EEA state other than UK; and b B determines that such a prescription is appropriate. 3 The specified information is— a the patient’s— i surname, ii first names written out in full, and iii date of birth; b the issue date of the prescription; c B’s— i surname, ii first names written out in full, iii professional qualification, iv direct contact details including— aa email address, bb telephone or fax number with the appropriate international prefix, v work address, vi confirmation that B works as a health professional in the UK, and vii electronic signature or a signature written in ink; d details about the prescribed product, including where applicable the— i common name of the product as defined by Article 1 of the 2001 Directive, ii brand name if— aa the prescribed product is a biological medicinal product, or bb B deems it medically necessary for that product to be dispensed and B’s reasons justifying the use of the branded product, iii pharmaceutical formulation (tablet, solution etc. ), iv quantity, v strength of the medicinal product as defined in Article 1 of the 2001 Directive, and vi dosage regimen. 4 A prescription under this regulation may only be issued by B in relation to those products that B is authorised to prescribe under regulation 214(3) to (5B). Amendment of regulation 218 7 1 Regulation 218 (requirements for prescriptions: EEA health professionals) is amended as follows. 2 For paragraph (2) substitute— 2 Condition A is that— a the prescription is issued in an EEA State other than the United Kingdom or Switzerland; and b the prescribing EEA health professional is legally entitled to issue a prescription of that kind in the EEA State in which the prescription is issued. 3 For paragraph (3) substitute— 3 Condition B is that the prescription is signed in ink by the prescribing EEA health professional. 4 For paragraph (5) substitute— 5 Condition D is that the prescription contains— a the patient’s— i surname, ii first names written out in full, and iii date of birth; b the issue date of the prescription; c the prescribing EEA health professional’s— i surname, ii first names written out in full, iii professional qualifications, iv direct contact details including— aa email address, and bb telephone or fax number with the appropriate international prefix, v work address, and vi name of the relevant member State in which that EEA health professional works; and d details about the prescribed product, including where applicable the— i common name of the product, ii ii)brand name if— aa the prescribed product is a biological medicinal product, or bb the prescribing EEA health professional deems it medically necessary for that product to be dispensed and the EEA health professional’s reasons justifying the use of the branded product, iii pharmaceutical formulation (tablet, solution, etc.), iv quantity, v strength of the medicinal product as defined in Article 1 of the 2001 Directive, and vi dosage regimen. Amendment of regulation 219 8 In regulation 219 (electronic prescriptions) for paragraph (4)(b) substitute b signed with— i an advanced electronic signature in the case of a prescription falling within paragraph (2), or ii an electronic signature in the case of a prescription falling within paragraph (3); and . Amendment of regulation 346 9 1 Regulation 346 (review provisions) is amended as follows. 2 In paragraph (2)— a In sub-paragraph (c) after paragraph “(xxviiia)” insert— xxviiib 213(3), xxviiic xxviiic)217A, xxviiid xxviiid)218(2)(b) and (c), (3) and (5), xxviiie xxviiie)219(4)(b)(ii), ; and b In sub-paragraph (d) for paragraph “(iv)” substitute— iv 12 paragraph 21, iva iva)17, Part 4 items 11 and 12 , and 3 For paragraph (4) substitute— 4 In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how— a the 2001 Directive; b Directive 2010/84/ EU of the European Parliament and of the Council of 15 October 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. ; c Article 11 of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare ; d Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products ; and e Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State , are implemented in other member States in relation to the subject matter of the provisions mentioned in paragraph (2). 4 In paragraph (5)(a) for “(xxix)” substitute “(xxxii)”. Amendment of Schedule 1 10 In paragraph 1(b) of Part 1 of Schedule 1 (further provisions for classification of medicinal products certain medicinal products to be available only on prescription), after “controlled drug” insert “as defined in section 2(1)(a) of the Misuse of Drugs Act 1971 ”. Amendment of Schedule 17 11 In Part 3 of Schedule 17 (exemption from the restriction on administration of prescription only medicines), after item 9 in the table add— 10. Persons (“P”) who are members of Her Majesty’s armed forces. 10. All prescription only medicines. 10. The administration shall be— (a) in the course of P undertaking any function as a member of Her Majesty’s armed forces; and (b) where P is satisfied that it is not practicable for another person who is legally entitled to administer a prescription only medicine to do so; and (c) only in so far as is necessary— (i) for the treatment of a sick or injured person in an emergency, or (ii) to prevent ill-health where there is a risk that a person would suffer ill-health if the prescription only medicine is not administered. Signed by the authority of the Secretary of State. Earl Howe Parliamentary Under-Secretary of State, Department of Health 26th February 2014 Edwin Poots Minister for Health, Social Services and Public Safety 4th March 2014