The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 12 U.K. Amendment of Part 12 (dealings with medicinal products)

Amendment of regulation 213 (interpretation of Part 12) U.K.

179.  In regulation 213(1) M1 —

(a) insert at the appropriate place—

““approved country health professional” means a person who is practising in a profession included in the list published under regulation 214(6A) in a country that is included in that list in relation to that profession;”;

(b) omit the definition of “EEA health professional”M2 ; and

(c) in the definition of “relevant prescriber”, for “EEA health professional” substitute “ approved country health professional ”.

Commencement Information

I1 Reg. 179 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M1 Regulation 213 was amended by S.I. 2013/235 and 2014/490 and 1878.

M2 The definition was substituted by S.I. 2014/1878.

Amendment of regulation 214 (sale or supply of prescription only medicines) U.K.

180.—(1) Regulation 214 M3 is amended as follows.

(2) In paragraph (2)(a), for “EEA health professional” substitute “ approved country health professional ”.

(3) In paragraph (6), for “EEA health professional” substitute “ approved country health professional ”.

(4) After paragraph (6) insert—

“(6A) The licensing authority must publish a list of approved countries and professions for the purposes of the definition of “approved country health professional”.

(6B) In order to determine whether a country or profession should be included in the list published under paragraph (6A), the licensing authority may, in particular, take into account—

(a) the country's standards of professional qualification;

(b) the country's system for ensuring that qualified professionals have undergone training which meets the requirements that apply in that country;

(c) the effectiveness of enforcement of professional standards;

(d) the mechanisms the country has in place to assist members of the public in obtaining information in respect of a qualified professional who is established there; and

(e) the regularity and rapidity of information provided by that country relating to non-compliant professionals.

(6C) The licensing authority must—

(a) review a country or profession it has included in the list published under paragraph (6A) to determine if it is still satisfied that they should remain on the list, and if it is not so satisfied, remove it from that list; and

(b) undertake such a review at least every 3 years beginning with the date on which that country or profession was included in that list.”.

Commencement Information

I2 Reg. 180 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M3 Regulation 214 was amended S.I. 2013/1855, 2014/490, 2016/186 and 2018/199.

Amendment of regulation 216 (exceptions to regulation 215) U.K.

181.  In regulation 216(2), for “EEA health professional” substitute “ approved country health professional ”.

Commencement Information

I3 Reg. 181 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 217 (requirements for prescriptions: general) U.K.

182.  In regulation 217(8)(a) M4 , for “EEA health professional” substitute “ approved country health professional ”.

Commencement Information

I4 Reg. 182 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M4 Regulation 217 was amended by S.I. 2014/490.

Amendment of regulation 217A (requirements for prescriptions to be dispensed in an EEA State) U.K.

183.—(1) Regulation 217A M5 is amended as follows.

(2) In the heading, omit “other than the UK”.

(3) In paragraph (2)(a), omit “other than the UK”.

Commencement Information

I5 Reg. 183 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M5 Regulation 217A was inserted by S.I. 2014/490.

Amendment of regulation 218 (requirements for prescriptions: EEA health professionals) U.K.

184.—(1) Regulation 218 M6 is amended as follows.

(2) In the heading, and each place where it subsequently occurs, for “EEA health professional” substitute “ approved country health professional ”.

(3) In paragraph (5)(c) and (d)(ii)(bb), for “EEA health professional's” substitute “approved country health professional's”.

(4) In paragraph (2)(a), for “relevant European State except the United Kingdom” substitute “ country included in the list published under regulation 214(6A) ”.

Commencement Information

I6 Reg. 184 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M6 Regulation 218 was amended by S.I. 2014/490 and 1878 and 2015/903.

Amendment of regulation 219 (electronic prescriptions) U.K.

185.  In regulation 219(2) M7 , for “EEA health professional” substitute “ approved country health professional ”.

Commencement Information

I7 Reg. 185 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M7 Regulation 219 was amended by S.I. 2015/903 and 2016/696.

Amendment of regulation 219A (electronic prescriptions: EEA health professionals) U.K.

186.—(1) Regulation 219A M8 is amended as follows.

(2) In the heading, for “EEA health professionals” substitute “ approved country health professionals ”.

(3) In paragraph (2), for “EEA health professional” substitute “ approved country health professional ”.

Commencement Information

I8 Reg. 186 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M8 Regulation 219A was amended by S.I. 2015/903.

Amendment of regulation 229 (exemption for supply by national health services bodies and local authorities) U.K.

[F1 187.   In regulation 229(3), for sub-paragraph (f) substitute—

“(f) when the product is supplied—

(i) in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or

(ii) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.”.]

Textual Amendments

F1 Reg. 187 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 141

Commencement Information

I9 Reg. 187 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 230 (exemption for supply etc under a PGD to assist doctors or dentists) U.K.

[F2 188.   For regulation 230(8) substitute—

“(8) Condition G is that when the product is supplied or (as the case may be) administered —

(a) in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or

(b) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.”.]

Textual Amendments

F2 Reg. 188 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 142

Commencement Information

I10 Reg. 188 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 231 (exemption for supply etc under a PGD by independent hospitals etc.) U.K.

[F3 189.   For regulation 231(8) substitute—

“(8) Condition G is that when the product is supplied—

(a) in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or

(b) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.”.]

Textual Amendments

F3 Reg. 189 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 143

Commencement Information

I11 Reg. 189 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 232 (exemption for supply etc under a PGD by dental practices and clinics: England and Wales) U.K.

[F4 190.   For regulation 232(8) substitute—

“(8) Condition F is that when the product is supplied, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK) is in force in relation to it.”.]

Textual Amendments

F4 Reg. 190 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 144

Commencement Information

I12 Reg. 190 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 233 (exemption for supply etc under a PGD by a person conducting a retail pharmacy business) U.K.

[F5 191.   For regulation 233(7) substitute—

“(7) Condition F is that when the prescription only medicine is supplied or (as the case may be) administered—

(a) in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or

(b) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.”.]

Textual Amendments

F5 Reg. 191 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 145

Commencement Information

I13 Reg. 191 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 234 (exemption for supply etc of products under a PGD to assist the police etc) U.K.

[F6 192.   For regulation 234(9) substitute—

“(9) Condition H is that when the product is supplied—

(a) in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or

(b) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.”.]

Textual Amendments

F6 Reg. 192 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 146

Commencement Information

I14 Reg. 192 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of Schedule 17 (exemptions for sale, supply or administration by certain persons) U.K.

193.—(1) Schedule 17 M9 is amended as follows.

(2) In the table in Part 1, in column 1 in entry 10, [F7 for “marketing authorisations” substitute “UK marketing authorisations, EU marketing authorisations].

(3) In the table in Part 4, in columns 1 and 2 in entry 9, [F8 for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation].

Textual Amendments

F7 Words in reg. 193(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 147(a)

F8 Words in reg. 193(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 147(b)

Commencement Information

I15 Reg. 193 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M9 Schedule 17 was amended by S.I. 2014/1878, 2015/1503, 2016/186 and 2017/715,

Amendment of regulation 249 (restrictions on persons to be supplied with medicinal products) U.K.

194.  In regulation 249(2)—

(a) in sub-paragraph (a), insert “ UK ” before “marketing authorisation”;

[F9 (b) after sub-paragraph (a) insert—

“(aa) an EU marketing authorisation;”.]

Textual Amendments

F9 Reg. 194(b) substituted for reg. 194(b)(c) (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 148

Commencement Information

I16 Reg. 194 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

[F10 Amendment of regulation 251 (compliance with standards specified in certain publications) U.K.

194A.   In regulation 251 (compliance with standards specified in certain publications), after paragraph (5) insert—

“(6) In paragraph (1), (2) or (3) a product is to be treated as complying with the standard specified in the relevant monograph where—

(a) the product complies with the standard specified in a relevant marketing authorisation for the product concerned, and

(b) the standard specified in that marketing authorisation does not comply with the standard specified in the relevant monograph.

(7) In paragraph (6), “relevant marketing authorisation” means—

(a) an EU marketing authorisation;

(b) an authorisation granted by the licencing authority under Chapter 4 of Title III to the 2001 Directive; or

(c) a UKMA(GB) granted under the unfettered access route.”.]

Textual Amendments

F10 Reg. 194A inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 149

Commencement Information

I17 Reg. 194A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 254 (prohibitions concerning traceability of treatment with advanced therapy medicinal products) U.K.

195.  In regulation 254(2)(a), for the words from “laid down in” to the end, substitute—

“imposed pursuant to—

(a) as regards gametes and embryos, sections 12(3), and 33A to 33D of, and paragraph 1 of Schedule 3A to, the Human Fertilisation and Embryology Act 1990 M10 ;

(b) as regards blood cells, regulations 8, 9(e) and 14 of the Blood Safety and Quality Regulations 2005 M11 ; and

(c) as regards other cells and tissues, regulations 13 and 16 of, and paragraph 1 of Schedule 2 to, the Human Tissue (Quality and Safety for Human Application) Regulations 2007 M12 ;”.

Commencement Information

I18 Reg. 195 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M10 1990 c. 37. Sections 33A to 33D were inserted by the Human Fertilisation and Embryology Act 2008, c. 22.

M11 S.I. 2005/50. It has been amended by S.I. 2005/1098 and 2898, 2006/2013, 2007/604, 2008/525 and 941, 2009/372 and 3307, 2010/604, 2017/1320 and 2018/231.

M12 S.I. 2007/1523.

[F11 Amendment of regulation 255B (exception to Article 25 of Commission Regulation 2016/161: health care institutions) U.K.

196.   In regulation 255A(1), after “purpose of sale or supply,” insert “in Northern Ireland,”.

Textual Amendments

F11 Regs. 196, 196A substituted for reg. 196 (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 150

Commencement Information

I19 Reg. 196 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 255B (exception to Article 25 of Commission Regulation 2016/161: health care institutions) U.K.

196A.   In regulation 255B, after “medicinal products to the public” in the first place it occurs insert “in Northern Ireland”.]

Textual Amendments

F11 Regs. 196, 196A substituted for reg. 196 (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 150

Commencement Information

I20 Reg. 196A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1