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SCHEDULES

Regulation 3

SCHEDULE 2U.K.Pharmacists and pharmacy technicians

PART 1U.K.Amendments to legislation

InterpretationU.K.

1.  In this Schedule—

(a)the 1968 Act” means the Medicines Act 1968 M1;

(b)the 2010 Order” means the Pharmacy Order 2010 M2.

Commencement Information

I1Sch. 2 para. 1 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

Medicines Act 1968U.K.

2.  The 1968 Act is amended as follows.

Commencement Information

I2Sch. 2 para. 2 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

3.  In section 67E (interpretation of provisions about defences) M3, in the definition of “registrant”—U.K.

(a)in paragraph (a), for “2, 4 or 5” substitute “ or 2 ”;

(b)in paragraph (b), omit the words from “or the register” to “European State”.

Commencement Information

I3Sch. 2 para. 3 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M3Section 67E was inserted by S.I. 2018/181.

4.  In section 69 (general provisions about pharmacies) M4, omit subsection (1ZA).U.K.

Commencement Information

I4Sch. 2 para. 4 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M4Subsection (1ZA) was inserted by S.I. 2007/3101. Relevant amending instrument is S.I. 2010/231.

5.  In section 71 (business carried on by body corporate) M5, omit subsection (7).U.K.

Commencement Information

I5Sch. 2 para. 5 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M5Subsection (7) was substituted by S.I. 2010/231.

6.  In section 78 (restrictions on use of titles etc.) M6U.K.

(a)in subsection (5), omit the words from “or in the” to “European State”;

(b)in subsection (5A), omit “or 4”.

Commencement Information

I6Sch. 2 para. 6 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M6Subsections (5) and (5A) were substituted by S.I. 2010/231.

Pharmacy Order 2010U.K.

7.  The 2010 Order is amended as follows.

Commencement Information

I7Sch. 2 para. 7 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

8.  In article 3 (interpretation) M7 [F1, in sub-paragraph (1)]U.K.

(a)for the definition of “the Directive” substitute—

the Directive” means Directive 2005/36/EC of the European Parliament and of the Council of 7th September 2005 on the recognition of professional qualifications (OJ No L255, 30.09.2005, p 22), and any reference in this Order to the Directive or to any provision of the Directive is a reference to the Directive, or to that provision, as it had effect immediately before [F2IP completion day];;

(b)omit the definitions of “competent authority”, “Directive 2002/58/EC”, “European mutual recognition area”, “European professional card”, “exempt person”, “General Systems Regulations”, “IMI”, “IMI file” and “third country”;

(c)in the definition of “registered pharmacist”, omit “or 4”;

(d)in the definition of “registered pharmacy technician”, omit “or 5”.

Textual Amendments

Commencement Information

I8Sch. 2 para. 8 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M7Relevant amending instruments are S.I. 2011/1043, 2016/1030.

9.  In article 19 (establishment, maintenance of, and access, to the Register), in paragraph (2)—U.K.

(a)in the words before paragraph (a), for “five” substitute “ three ”;

(b)in paragraphs (a) and (b), omit “other than visiting practitioners”;

(c)at the end of paragraph (b), insert “ and ”;

(d)omit sub-paragraph (d) (including the final “and”);

(e)omit sub-paragraph (e).

Commencement Information

I9Sch. 2 para. 9 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

10.  In article 20 (entitlement to entry in Parts 1 or 2 of the Register), for paragraph (4), substitute—U.K.

(4) The Registrar must treat a person who—

(a)applies to be entered in Part 1 of the Register as a pharmacist,

(b)qualified as a pharmacist in a relevant European State,

(c)was, on [F3IP completion day], in the register of pharmaceutical chemists for Northern Ireland, or was entered in that register on or after [F3IP completion day] further to an application made before [F3IP completion day], and

(d)has remained in that register since [F3IP completion day] or, as the case may be, since that entry (disregarding any period in which the person was not in the register as a result of a decision that was later overturned in an appeal or other legal proceeding),

as meeting the requirements of paragraph (1)(a)(i)..

Textual Amendments

Commencement Information

I10Sch. 2 para. 10 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

11.—(1) Article 21 (pre-entry requirements in respect of qualifications and additional education, training or experience: pharmacists) M8 is amended as follows.U.K.

(2) In paragraph (1)—

(a)in sub-paragraph (a), omit the words from “(and” to the end;

(b)omit sub-paragraph (b);

(c)omit sub-paragraph (c) (but not the final “or”);

(d)in sub-paragraph (d)—

(i)in the words before paragraph (i), omit “subject to paragraph (2),”;

(ii)omit paragraph (ii)(aa) (including the final “or”);

(iii)in paragraph (ii)(bb), omit “whether or not P is an exempt person,”.

(3) After paragraph (1), insert—

(1A) A relevant European qualification is to be treated as a qualification which has been approved under paragraph (1)(d)(i).

(1B) In this article “relevant European qualification” means—

(a)a qualification that falls within article 21A and has not been designated by the Council for the purposes of this sub-paragraph, or

(b)a qualification in pharmacy that does not fall within article 21A but—

(i)was granted in a relevant European State, and

(ii)attests, in the opinion of the Council, to a comparable standard of proficiency to that attested to by a qualification approved under paragraph (1)(a).

(1C) The Council—

(a)may designate a qualification for the purposes of paragraph (1B)(a) only with the approval of the Privy Council;

(b)must maintain and publish a list of the qualifications that are so designated..

(4) Omit paragraphs (2) to (5).

Commencement Information

I11Sch. 2 para. 11 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M8Relevant amending instrument is 2016/1030.

12.  After article 21, insert—U.K.

European qualifications: pharmacists

21A.(1) Subject to the following provisions of this article, a qualification falls within this article if it was awarded in a relevant European State and is listed in Annex V, point 5.6.2 of the Directive.

(2) A qualification falls within this article only if it is accompanied, where applicable, by the certificate listed in relation to the qualification in the column entitled “Certificate accompanying the diploma” in Annex V, point 5.6.2 of the Directive.

(3) A qualification does not fall within this article if it was awarded before the reference date, or is evidence of training begun before that date.

(4) In paragraph (3) “reference date” means the date listed in relation to the State in which the qualification was awarded in the column entitled “Reference date” in Annex V, point 5.6.2 of the Directive..

Commencement Information

I12Sch. 2 para. 12 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

13.—(1) Article 22 (pre-entry requirements in respect of qualifications and additional education, training or experience: pharmacy technicians) is amended as follows.U.K.

(2) In paragraph (1)—

(a)in sub-paragraph (a), at the end insert “ or ”;

(b)omit sub-paragraph (b) (including the final “or”);

(c)in sub-paragraph (c)—

(i)in paragraph (i), omit the final “or”;

(ii)after paragraph (i), insert—

(ia)holds a qualification which was granted in a relevant European State and, despite its not having been approved under paragraph (i), attests, in the opinion of the Council, to a comparable standard of proficiency to that attested to by a qualification approved under paragraph (1)(a), or;

(iii)omit paragraph (ii)(aa);

(iv)in paragraph (ii)(bb) omit “whether or not T is an exempt person,”.

(3) Omit paragraphs (2) and (3).

Commencement Information

I13Sch. 2 para. 13 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

14.—(1) Article 23 (form, manner and content of applications for entry or for renewal of an entry in the register: pharmacists and pharmacy technicians) M9 is amended as follows.U.K.

(2) In paragraph (1)(c)—

(a)in paragraph (iii)—

(i)omit “who is not an exempt person”;

(ii)at the end insert “ and ”;

(b)omit paragraph (iv);

(c)omit paragraph (vi) (including the final “and”).

(3) Omit paragraphs (4) to (11).

Commencement Information

I14Sch. 2 para. 14 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M9Relevant amending instrument is S.I. 2016/1030.

15.  In article 23A (supplementary provisions as to necessary knowledge of English) M10, omit paragraphs (5) and (7).U.K.

Commencement Information

I15Sch. 2 para. 15 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M10Article 23A was inserted by S.I. 2015/806.

16.—(1) Article 24 (notification by the Registrar: entry and renewal) M11 is amended as follows.U.K.

(2) Omit paragraphs (2A) and (2B).

(3) In paragraph (3), for “specified period” substitute “ period of three months beginning with the relevant date ”.

(4) In paragraph (4)—

(a)omit sub-paragraph (a) (including the final “or”);

(b)in the words after sub-paragraph (b)—

(i)omit the words from “a decision”, where it first occurs, to “or”;

(ii)omit “(as the case may be)”;

(iii)for “specified period” substitute “ period of three months beginning with the relevant date ”.

(5) Omit paragraph (5).

(6) In paragraph (5A), for “any period of time for the purposes of paragraph (5)” substitute “ the period of three months for the purposes of paragraph (3) or (4) ”.

Commencement Information

I16Sch. 2 para. 16 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M11Paragraphs (2A), (2B) and (5A) were inserted, and paragraphs (4) and (5) were amended, by S.I. 2015/806.

17.  In article 29 (corrections to the Register), in paragraph (3)(a), omit “or in Part 4 or 5 of the Register”.U.K.

Commencement Information

I17Sch. 2 para. 17 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

18.  In article 32 (indemnity arrangements) M12, omit paragraph (11).U.K.

Commencement Information

I18Sch. 2 para. 18 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M12Article 32 was substituted by S.I. 2014/1887.

19.  Omit article 33 (visiting pharmacists and pharmacy technicians from relevant European States).U.K.

Commencement Information

I19Sch. 2 para. 19 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

20.  Omit article 33A (European professional card) M13.U.K.

Commencement Information

I20Sch. 2 para. 20 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M13Article 33A was inserted by S.I. 2016/1030. Relevant amendments made by paragraph 354 of Schedule 19 to the Data Protection Act 2018.

21.  In article 36 (fees in connection with entry)—U.K.

(a)in paragraph (1), for “Subject to paragraph (3), the” substitute “ The ”;

(b)omit paragraph (3).

Commencement Information

I21Sch. 2 para. 21 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

22.  In article 37 (restoration to the Register), in paragraph (5), for “, 2, 4 or 5” substitute “ or 2 ”.U.K.

Commencement Information

I22Sch. 2 para. 22 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

23.—(1) Article 38 (offences relating to the Register) is amended as follows.U.K.

(2) In paragraph (2)—

(a)in sub-paragraph (a), omit “or 4”;

(b)in sub-paragraph (b), omit “or 5”.

(3) In paragraph (4)—

(a)in sub-paragraph (a), omit “or 4”;

(b)in sub-paragraph (b), omit “or 5”.

Commencement Information

I23Sch. 2 para. 23 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

24.—(1) Article 39 (appealable decisions) M14 is amended as follows.U.K.

(2) In paragraph (1)—

(a)omit sub-paragraphs (a), (c), (cb) and (e);

(b)in sub-paragraphs (i) and (l), for “, 2, 4 or 5” substitute “ or 2 ”;

(c)omit sub-paragraphs (t) and (u).

(3) Omit paragraph (1A).

Commencement Information

I24Sch. 2 para. 24 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M14Paragraph (1)(cb) was inserted by S.I. 2015/806. Paragraph (1)(t) and (u) and (1A) were inserted by S.I. 2016/1030.

25.  In article 40 (appeals to the Appeals Committee) M15U.K.

(a)omit paragraph (1A);

(b)in paragraph (2), omit sub-paragraph (b) (together with the “or” before it);

(c)in paragraph (7)—

(i)in sub-paragraph (b), omit the words from “or, in” to the end;

(ii)omit sub-paragraph (ca) (but not the final “or”).

Commencement Information

I25Sch. 2 para. 25 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M15Paragraphs (1A) and (7)(ca) were inserted by, and paragraph (7)(b) was amended by, S.I. 2016/1030.

26.  In article 41 (appeals from the Appeals Committee) M16, in paragraph (4)—U.K.

(a)in sub-paragraph (b), omit the words from “or, in” to the end;

(b)omit sub-paragraph (ca) (but not the final “or”).

Commencement Information

I26Sch. 2 para. 26 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M16Paragraph (4)(ca) was inserted by, and paragraph (4)(b) was amended by, S.I. 2016/1030.

27.  In article 42 (education, training and acquisition of experience) M17, in paragraph (1)(a), omit from “except” to “22(1)(b),”.U.K.

Commencement Information

I27Sch. 2 para. 27 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M17Relevant amending instrument is S.I. 2016/1030.

28.  Omit article 42A (professional traineeships carried out in other relevant European States, etc) M18.U.K.

Commencement Information

I28Sch. 2 para. 28 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M18Article 42A was inserted by S.I.2016/1030.

29.  In article 43 (continuing professional development)—U.K.

(a)omit paragraph (5)(c);

(b)omit paragraph (8)(b);

(c)omit paragraph (9).

Commencement Information

I29Sch. 2 para. 29 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

30.  In article 66 (rules), omit paragraph (2).U.K.

Commencement Information

I30Sch. 2 para. 30 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

31.  Omit article 67 (The Directive: designation of competent authority etc) M19.U.K.

Commencement Information

I31Sch. 2 para. 31 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M19Relevant amendments made by paragraph 357 of Schedule 19 to the Data Protection Act 2018, S.I. 2016/1030.

32.  Omit article 71 (review) M20.U.K.

Commencement Information

I32Sch. 2 para. 32 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M20Article 71 was inserted by S.I. 2016/1030.

33.  Omit Schedule 2 (visiting pharmacists and pharmacy technicians from relevant European States) M21.U.K.

Commencement Information

I33Sch. 2 para. 33 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M21Relevant amending instrument is S.I. 2016/1030.

34.  Omit Schedule 2A (European professional card) M22.U.K.

Commencement Information

I34Sch. 2 para. 34 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M22Schedule 2A was inserted by S.I. 2016/1030. Relevant amendments made by paragraph 358 of Schedule 19 to the Data Protection Act 2018.

35.  Omit Schedule 3 (The Directive: designation of competent authority etc) M23.U.K.

Commencement Information

I35Sch. 2 para. 35 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M23Relevant amendments made by paragraph 359 of Schedule 19 to the Data Protection Act 2018, S.I. 2015/806, 2016/1030.

Medicines for Human Use (Clinical Trials) Regulations 2004U.K.

36.  In the Medicines for Human Use (Clinical Trials) Regulations 2004 M24, in regulation 2(1) (interpretation), in the definition of “pharmacist”—

(a)in paragraph (a), omit “or 4”;

(b)in paragraph (b), omit the words from “, or the” to “European State,”.

Commencement Information

I36Sch. 2 para. 36 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M24S.I. 2004/1031. Paragraph (a) was substituted by S.I. 2010/231, and paragraph (b) was amended by, S.R. 2008 No.192.

Approved European Pharmacy Qualifications Order of Council 2007U.K.

37.  The Approved European Pharmacy Qualifications Order of Council 2007 M25 is revoked.

Commencement Information

I37Sch. 2 para. 37 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009U.K.

38.  In the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009 M26, in regulation 2 (interpretation), in paragraph (1), in the definition of “pharmacist”, omit “or 4”.

Commencement Information

I38Sch. 2 para. 38 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M26S.S.I. 2009/183. Relevant amending instrument is S.I. 2010/231.

General Pharmaceutical Council (Registration) Rules 2010U.K.

39.—(1) The General Pharmaceutical Council (Registration) Rules 2010 M27 are amended as follows.

(2) In rule 10 (entry in the Register)—

(a)in paragraph (3)—

(i)omit sub-paragraphs (e), (f), (h) and (i);

(ii)in sub-paragraph (j)—

(aa)omit paragraph (i) (including the final “or”);

(bb)in paragraph (ii), omit from “in”, where it first occurs, to “way),”;

(iii)in sub-paragraph (k)—

(aa)omit paragraph (i) (including the final “and”);

(bb)in paragraph (ii), omit “whether or not the applicant is an exempt person,”;

(b)omit paragraph (3ZA);

(c)in paragraph (12), omit the definition of “attesting state” (including the final “and”).

(3) In the heading to Part 4, for “, 2, 4 and 5” substitute “ and 2 ”.

(4) In rule 18 (notice of intention to remove: stage 1)—

(a)in paragraph (1)(a), omit “, 4 or 5”;

(b)in paragraph (5)(a)(i), omit “, 4 or 5”.

(5) In rule 19 (subsequent action by Registrar: stage 2)—

(a)in paragraph (1), omit “, 4 or 5”;

(b)in paragraph (4)(a), omit “, 4 or 5”;

(c)in paragraph (5)(b), omit “, 4 or 5”.

(6) In rule 20 (decisions in contested cases: stage 3), in paragraph (3)(a), omit “, 4 or 5”.

Commencement Information

I39Sch. 2 para. 39 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M27As set out in the Schedule to the General Pharmaceutical Council (Registration Rules) Order of Council 2010 (S.I. 2010/1617). Paragraph 10(3ZA) was inserted by S.I. 2016/1030. Paragraph 10(12) was substituted by S.I. 2010/2660. Relevant amending instruments are S.I. 2012/3171, 2016/1008, 1030.

Pharmacy Order 2010 (Approved European Pharmacy Qualifications) Order 2010U.K.

40.  The Pharmacy Order 2010 (Approved European Pharmacy Qualifications) Order 2010 M28 is revoked.

Commencement Information

I40Sch. 2 para. 40 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

General Pharmaceutical Council (Continuing Professional Development and Consequential Amendments) Rules 2011U.K.

41.—(1) The General Pharmaceutical Council (Continuing Professional Development and Consequential Amendments) Rules 2011 M29 are amended as follows.

(2) In rule 5 (steps which the Registrar may take)—

(a)in paragraph (2)(b), for “, 2, 4 or 5” substitute “ or 2 ”;

(b)omit paragraph (3).

(3) In rule 6 (remedial measures), in paragraph (1)(f), omit paragraph (ii) and the “or” before it.

(4) In rule 8 (subsequent action by the Registrar: stage 2), in paragraph (1), for “, 2, 4 or 5” substitute “ or 2 ”.

(5) In rule 9 (decisions in contested cases: stage 3), in paragraph (5), for “, 2, 4 or 5” substitute “ or 2 ”.

(6) In rule 11 (suspension from the register pending appeal), in paragraph (1)(a), for “, 2, 4 or 5” substitute “ or 2 ”.

Commencement Information

I41Sch. 2 para. 41 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

Human Medicines Regulations 2012U.K.

42.  In the Human Medicines Regulations 2012 M30, in regulation 8(1) (interpretation)—

(a)in the definition of “health care professional”, in paragraph (d), omit “or 5”;

(b)in the definition of “pharmacist”—

(i)in paragraph (a), omit “or 4”;

(ii)in paragraph (b), omit the words from “or the” to “European State”.

Commencement Information

I42Sch. 2 para. 42 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013U.K.

43.  In the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 M31, in regulation 2(1)—

(a)in the definition of “registered pharmacist”, omit “or 4”;

(b)in the definition of “registered pharmacy technician”, omit “or 5”.

Commencement Information

I43Sch. 2 para. 43 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

PART 2U.K.Savings and transitional provision

Pending applicationsU.K.

44.  Where an application for entry in, or restoration to, a part of the register kept under the 2010 Order is received before [F4IP completion day], any provision made by or under that Order (except for provision contained in Schedule 2A to the Order) continues to apply in relation to the application (including any appeal arising from it) without the amendments made by Part 1 of this Schedule.

Textual Amendments

Commencement Information

I44Sch. 2 para. 44 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

[F5Swiss pharmacists qualifying outside the United Kingdom: saving of old lawU.K.

44A.(1) Where an application for registration in Part 1 of the Register is received from a qualifying Swiss applicant before the end of the Swiss recognition period, any provision made by an instrument amended by Part 1 of this Schedule continues to apply in relation to the application (including any appeal arising from it) without the amendments that Part 1 of this Schedule makes to the establishment provisions (but subject to the modifications to the 2010 Order and the General Pharmaceutical Council (Registration) Rules 2010 specified in sub-paragraphs (3) and (4)).

(2) The reference in sub-paragraph (1) to “the establishment provisions” is a reference to the provisions of the following enactments—

(a)the 2010 Order, other than articles 19(2)(d) and (e), 32(11), 33, 33A, 36(3), 39(1)(c) and (e), 66(2) and 71, and Schedule 2A;

(b)the Approved European Pharmacy Qualifications Order of Council 2007;

(c)the General Pharmaceutical Council (Registration) Rules 2010;

(d)the Pharmacy Order 2010 (Approved European Pharmacy Qualifications) Order 2010.

(3) The modifications to the 2010 Order mentioned in sub-paragraph (1) are—

(a)article 3(1) is to be read as if—

(i)in the definitions of “the Directive” and “Directive 2002/58/EC”, for “as amended from time to time” there were substituted “as it had effect immediately before IP completion day”;

(ii)in the definition of “General Systems Regulations”, at the end, there were inserted “as (and only to the extent that) they have effect, after IP completion day, in relation to an entitlement which arises in relation to a relevant qualification (within the meaning given in regulation 1A of the European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019)”;

(iii)there were inserted at the appropriate place—

“qualifying Swiss applicant” has the meaning given in paragraph 44A(5) of Schedule 2 to the European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019;;

(iv)for the definition of “third country”, there were substituted—

“third country” has the same meaning as in regulation 2(1) of the 2007 Regulations.;

(b)article 20(4) is to be read as if, for sub-paragraph (a), there were substituted—

(a)is a qualifying Swiss applicant who has qualified as a pharmacist in a relevant European State;;

(c)article 21 is to be read as if—

(i)in paragraph (1), in sub-paragraphs (b) and (c), for “an exempt person”, there were substituted “a qualifying Swiss applicant”;

(ii)in paragraph (1), in sub-paragraph (d)—

(aa)in the words before paragraph (i), “subject to paragraph (2)” were omitted;

(bb)in paragraph (ii)(aa), for “an exempt person” there were substituted “a qualifying Swiss applicant”;

(cc)in paragraph (ii)(bb), “whether or not P is an exempt person” were omitted;

(iii)paragraphs (2), and (4)(b) were omitted, and the “and” at the end of paragraph (4)(a) were omitted;

(iv)in paragraph (5)—

(aa)in the words before sub-paragraph (a), for “an exempt person” there were substituted “a qualifying Swiss applicant”;

(bb)in sub-paragraph (a), for “another relevant European State” there were substituted “a competent authority in Switzerland, pursuant to Article 2(2) of the Directive”;

(d)in article 23—

(i)paragraph (1)(c) is to be read as if—

(aa)paragraph (iii) were omitted;

(bb)in paragraph (iv), in the words before sub-paragraph (aa) and in sub-paragraph (bb), for “an exempt person” there were substituted “a qualifying Swiss applicant”;

(cc)in paragraph (iv)(aa) and (bb), for “a relevant European State” there were substituted “the United Kingdom or Switzerland”;

(dd)in paragraph (vi), for “an exempt person” there were substituted “a qualifying Swiss applicant”, and for “a relevant European State” there were substituted “Switzerland”;

(ii)paragraph (4) is to be read as if for “an exempt person” there were substituted “a qualifying Swiss applicant”;

(iii)paragraph (9) is to be read as if for the words from “in relation” to the end, there were substituted “in relation to a qualifying Swiss applicant, means Switzerland”;

(e)article 23A(7) is to be read as if for “an exempt person” there were substituted “a qualifying Swiss applicant”;

(f)article 36(1) is to be read as if for “Subject to paragraph (3), the” there were substituted “The”.

(4) The modifications to the General Pharmaceutical Council (Registration) Rules 2010 mentioned in sub-paragraph (1) are—

(a)rule 2 is to be read as if after the definition of “prescribed fee”, there were inserted—

“qualifying Swiss applicant” has the meaning given in paragraph 44A(5) of Schedule 2 to the European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019;;

(b)rule 10 is to be read as if—

(i)in paragraph (3)(e)—

(aa)in the words before paragraph (i), for “an exempt person within the meaning given in article 3(1) of the Order” there were substituted “a qualifying Swiss applicant”;

(bb)in paragraphs (i) and (ii), for “a relevant European State”, in each place it occurs, there were substituted “the United Kingdom or Switzerland”;

(cc)in paragraph (ii), for “Community right by virtue of which the applicant is an exempt person” there were substituted “enforceable EU right by virtue of which the applicant is a qualifying Swiss applicant”;

(ii)in paragraph (3)(f), for “a relevant European State”, in each place it occurs, there were substituted “the United Kingdom or Switzerland”;

(iii)in paragraph (3)(h), in the words before paragraph (i), for “an exempt person” there were substituted “a qualifying Swiss applicant”;

(iv)in paragraph (3)(i), in the words before paragraph (i), for “an exempt person” there were substituted “a qualifying Swiss applicant”;

(v)in paragraph (3)(j), in paragraphs (i) and (ii), for “an exempt person”, in each place it occurs, there were substituted “a qualifying Swiss applicant”;

(vi)in paragraph (3)(k)—

(aa)in paragraph (i), for “an exempt person” there were substituted “a qualifying Swiss applicant”;

(bb)in paragraph (ii), “, whether or not the applicant is an exempt person,” were omitted;

(vii)paragraph (3ZA) were omitted;

(viii)in paragraph (12), for the definition of “attesting State” there were substituted—

“attesting State” means Switzerland;.

(5) For the purposes of this paragraph—

“qualifying Swiss applicant” means a qualifying applicant who had not, before IP completion day, made a registration application (other than an application for registration under Schedule 2 to the 2010 Order);

“the Register” has the meaning given in article 3(1) of the 2010 Order, as it had effect immediately before IP completion day.]

Textual Amendments

Commencement Information

I45Sch. 2 para. 44A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

[F5Swiss pharmacy technicians qualifying outside the United Kingdom: saving of old lawU.K.

44B.(1) Where an application for registration in Part 2 of the Register is received from a Swiss pharmacy technician before the end of the Swiss recognition period, any provision made by an instrument amended by Part 1 of this Schedule continues to apply in relation to the application (including any appeal arising from it) without the amendments that Part 1 of this Schedule makes to the establishment provisions (but subject to the modifications to the 2010 Order and the General Pharmaceutical Council (Registration) Rules 2010 specified in sub-paragraphs (3) and (4)).

(2) The reference in sub-paragraph (1) to “the establishment provisions” is a reference to the provisions of the following enactments—

(a)the 2010 Order, other than articles 19(2)(d) and (e), 32(11), 33, 36(1) and (3), 39(1)(c) and (e), [F666(2) and 71];

(b)the General Pharmaceutical Council (Registration) Rules 2010.

(3) The modifications to the 2010 Order mentioned in sub-paragraph (1) are—

(a)article 3(1) is to be read as if—

(i)in the definitions of “the Directive” and “Directive 2002/58/EC”, for “as amended from time to time” there were substituted “as it had effect immediately before IP completion day”;

(ii)in the definition of “General Systems Regulations”, at the end, there were inserted “as (and only to the extent that) they have effect, after IP completion day, in relation to an entitlement which arises in relation to a relevant qualification (within the meaning given in regulation 1A of the European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019)”;

(iii)there were inserted at the appropriate place—

“Swiss pharmacy technician” has the meaning given in paragraph 44B(5) of Schedule 2 to the European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019;;

(iv)for the definition of “third country”, there were substituted—

“third country” has the same meaning as in regulation 2(1) of the 2007 Regulations.;

(b)article 22 is to be read as if—

(i)in paragraph (1)(b), for “an exempt person” there were substituted “a Swiss pharmacy technician”;

(ii)in paragraph (1)(c)—

(aa)in paragraph (ii)(aa), for “an exempt person” there were substituted “a Swiss pharmacy technician”;

(bb)in paragraph (ii)(bb), “whether or not T is an exempt person,” were omitted;

(iii)in paragraph (2)—

(aa)in the words before sub-paragraph (a), for “exempt person” there were substituted “Swiss pharmacy technician”;

(bb)in sub-paragraph (b), after “the Directive” there were inserted “as they had effect immediately before IP completion day”;

(iv)in paragraph (3)—

(aa)in the words before sub-paragraph (a) for “an exempt person” there were substituted “a Swiss pharmacy technician”;

(bb)in sub-paragraph (a), for “another relevant European State” there were substituted “a competent authority in Switzerland pursuant to Article 2(2) of the Directive”;

(c)article 23(1) is to be read as if in sub-paragraph (c)—

(i)paragraph (iii) were omitted;

(ii)in paragraph (iv)—

(aa)in the words before sub-paragraph (aa) and in sub-paragraph (bb), for “an exempt person” there were substituted “a Swiss pharmacy technician”;

(aa)in sub-paragraphs (aa) and (bb), for “a relevant European State” there were substituted “the United Kingdom or Switzerland”;

(iii)in paragraph (vi)—

(aa)for “an exempt person” there were substituted “a Swiss pharmacy technician”;

(bb)for “a relevant European State” there were substituted “Switzerland”;

(d)article 23(4) is to be read as if for “an exempt person” there were substituted “a Swiss pharmacy technician”;

(e)article 23(9) is to be read as if for the words from “in relation” to the end, there were substituted “in relation to a Swiss pharmacy technician, means Switzerland”;

(f)article 23A(7) is to be read as if for “an exempt person” there were substituted “a Swiss pharmacy technician”;

(g)article 36(1) is to be read as if for “Subject to paragraph (3), the” there were substituted “The”.

(4) The modifications to the General Pharmaceutical Council (Registration) Rules 2010 mentioned in sub-paragraph (1) are—

(a)rule 2 is to be read as if after the definition of “prescribed fee” there were inserted—

“Swiss pharmacy technician” has the meaning given in paragraph 44B(5) of Schedule 2 to the European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019;;

(b)rule 10 is to be read as if—

(i)in paragraph (3)(e)—

(aa)in the words before paragraph (i), for “an exempt person within the meaning given in article 3(1) of the Order” there were substituted “a Swiss pharmacy technician”;

(bb)in paragraphs (i) and (ii), for “a relevant European State”, in each place it occurs, there were substituted “the United Kingdom or Switzerland”;

(cc)in paragraph (ii), for “Community right by virtue of which the applicant is an exempt person” there were substituted “enforceable EU right by virtue of which the applicant is a Swiss pharmacy technician”;

(ii)in paragraph (3)(f), for “a relevant European State”, in each place it occurs, there were substituted “the United Kingdom or Switzerland”;

(iii)in paragraph (3)(h), in the words before paragraph (i), for “an exempt person” there were substituted “a Swiss pharmacy technician”;

(iv)in paragraph (3)(i), in the words before paragraph (i), for “an exempt person” there were substituted “a Swiss pharmacy technician”;

(v)in paragraph (3)(j), in paragraphs (i) and (ii), for “an exempt person” there were substituted “a Swiss pharmacy technician”;

(vi)in paragraph (3)(k)—

(aa)in paragraph (i), for “an exempt person” there were substituted “a Swiss pharmacy technician”;

(bb)in paragraph (ii) “, whether or not the applicant is an exempt person,” were omitted;

(vii)paragraph (3ZA) were omitted;

(viii)in paragraph (12), for the definition of “attesting State” there were substituted—

“attesting State” means Switzerland;.

(5) For the purposes of this paragraph—

“the Register” has the meaning given in article 3(1) of the 2010 Order, as it had effect immediately before IP completion day;

“Swiss pharmacy technician” means a qualifying applicant who had not, before IP completion day, made a registration application.]

Textual Amendments

Commencement Information

I46Sch. 2 para. 44B in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Visiting pharmacists and pharmacy technicians: saving of old law for up to [F7five years] U.K.

45.—(1) Where, immediately before [F8IP completion day]

(a)a visiting pharmacist or pharmacy technician was entitled under paragraph 3, 6, 11 or 14 of Schedule 2 to the 2010 Order to provide occasional pharmacy services, or

(b)the Registrar was in receipt of the required documents (within the meaning of paragraph 4 or 12 of that Schedule) from a pharmacist or pharmacy technician seeking to acquire that entitlement,

any provision made by an Act or instrument amended by Part 1 of this Schedule continues to apply in relation to the pharmacist or technician without the amendments that Part 1 of this Schedule makes to the provisions relating to visiting practitioners from relevant European States [F9(but subject, in the case of a Swiss visiting practitioner, to the modifications to the 2010 Order specified in sub-paragraph (4))].

(2) But a visiting practitioner's entitlement does not continue (or further continue) under paragraph 6 or 14 of Schedule 2 to the 2010 Order on or after [F10IP completion day] (and, accordingly, the entitlement lapses at the end of—

(a)in the case of a pharmacist, the period mentioned in paragraph 7(1) or (2) of that Schedule;

(b)in the case of a pharmacy technician, the period mentioned in paragraph 15(1) or (2) of that Schedule).

[F11(2A) Sub-paragraph (2) does not apply in the case of a Swiss visiting practitioner.

(2B) But a Swiss visiting practitioner’s entitlement does not continue (or further continue) under paragraph 6 or 14 of Schedule 2 to the 2010 Order after the end of the visiting practitioner transitional period (and, accordingly, the entitlement lapses at the end of—

(a)in the case of a pharmacist, the period mentioned in paragraph 7(1) or (2) of that Schedule;

(b)in the case of a pharmacy technician, the period mentioned in paragraph 15(1) or (2) of that Schedule).

(2C) In this paragraph, “Swiss visiting practitioner” means a visiting practitioner who—

(a)is a national of the United Kingdom or Switzerland, or

(b)a third country national, who was, immediately before IP completion day, entitled by virtue of an enforceable EU right to be treated, for the purposes of access to and pursuit of the profession of pharmacist or pharmacy technician, no less favourably than a national of the United Kingdom or Switzerland.]

(3) The reference in sub-paragraph (1) to “the provisions relating to visiting practitioners from relevant European States” is to the provisions listed in the following table.

InstrumentProvision relating to visiting practitioners
The 1968 Actsection 67E
section 69(1ZA)
section 71(7)
section 78(5) and (5A)
The 2010 Orderin article 3(1), the definitions of “competent authority”, “exempt person”, “General Systems Regulations”, “registered pharmacist” and “registered pharmacy technician”
article 19(2)(d) and (e)
article 29(3)(a)
article 32(11)
article 33
article 36(3)
article 37(5)
article 38(2) and (4)
article 39(1)(c), (e), (i) and (l)
article 43(5)(c), (8)(b) and (9)
Schedule 2
Medicines for Human Use (Clinical Trials) Regulations 2004regulation 2(1)
National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009regulation 2(1)
General Pharmaceutical Council (Registration) Rules 2010rule 18(1)(a) and (5)(a)(i)
rule 19(1), (4)(a) and (5)(b)
rule 20(3)(a)
General Pharmaceutical Council (Continuing Professional Development and Consequential Amendments) Rules 2011rule 5(2)(b) and (3)
rule 6(f)(ii)
rule 8(1)
rule 9(5)
rule 11(1)(a)
Human Medicines Regulations 2012regulation 8(1)
National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013regulation 2(1)

[F12(4) The modifications to the 2010 Order mentioned in sub-paragraph (1) are—

(a)article 3(1) is to be read as if in the definition of “competent authority” for “a relevant European State” there were substituted “Switzerland”;

(b)article 43(9) is to be read as if, for the words from “the relevant” to the end, there were substituted “Switzerland”;

(c)Part 1 of Schedule 2 is to be read as if—

(i)for paragraph 1(1), there were substituted—

(1) This Part of this Schedule applies to a Swiss visiting practitioner who is lawfully established as a pharmacist in Switzerland.;

(ii)in paragraph 1(2)—

(aa)before paragraph (a), there were inserted—

(za)an “existing contract” means a written contract which was concluded, and performance of which started, before IP completion day;

(zb)“Swiss visiting practitioner” has the meaning given in paragraph 45(2C) of Schedule 2 to the European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019;;

(bb)in paragraph (a), for “an exempt person” there were substituted “a Swiss visiting practitioner”;

(cc)in paragraph (b), for the words from “the relevant” to the end, there were substituted “Switzerland”;

(dd)in paragraph (c), after “basis” there were inserted—

(i)on the basis of one or more existing contracts, and

(ii)for a period not exceeding 90 days in total in any calendar year.;

(iii)in paragraph 4(2)—

(aa)in paragraph (b), for “a relevant European State” there were substituted “the United Kingdom or Switzerland”;

(bb)in paragraph (c), for the words from “a relevant European State” to the end, there were substituted “the United Kingdom or Switzerland, proof of the enforceable EU right by virtue of which the practitioner is a Swiss visiting practitioner”;

(iv)in paragraph 6—

(aa)sub-paragraphs (3) and (4) were omitted;

(bb)in sub-paragraph (6), after paragraph (a), there were inserted—

(aa)contains details of the existing contract or contracts on the basis of which the occasional pharmacy services will continue to be provided;

(ab)if the practitioner is a national of the United Kingdom or Switzerland, contains proof of nationality;

(ac)if the practitioner is not a national of the United Kingdom or Switzerland, contains proof of the enforceable EU right by virtue of which the practitioner is a Swiss visiting practitioner;;

(v)paragraph 7(7) is to be read as if, for paragraph (b), there were substituted—

(b)(i)immediately before the time when the supervision or, as the case may be, removal takes effect, the practitioner is entitled under this Part to provide occasional pharmacy services, or

(ii)the existing contract, or last of the existing contracts, on the basis of which the visiting practitioner was providing occasional pharmacy services, is terminated or otherwise expires,;

(d)Part 2 of Schedule 2 is to be read as if—

(i)in paragraph 9(1), for the words from “an exempt person” to the end, there were substituted “a Swiss visiting practitioner who is lawfully established as a pharmacy technician in Switzerland”;

(ii)in paragraph 9(2)—

(aa)before paragraph (a) there were inserted—

(za)an “existing contract” means a written contract which was concluded, and performance of which started, before IP completion day;

(zb)“Swiss visiting practitioner” has the meaning given in paragraph 45(2C) of Schedule 2 to the European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019;;

(bb)in paragraph (a), for “an exempt person” there were substituted “a Swiss visiting practitioner”;

(cc)in paragraph (b), for the words from “the relevant” to the end, there were substituted “Switzerland”;

(dd)in paragraph (c), after “basis” there were inserted—

(i)on the basis of one or more existing contracts, and

(ii)for a period not exceeding 90 days in total in any calendar year.;

(iii)in paragraph 12(2)—

(aa)in paragraph (b), for “a relevant European State” there were substituted “the United Kingdom or Switzerland”;

(bb)in paragraph (c), for the words from “a relevant European State” to the end there were substituted “the United Kingdom or Switzerland, proof of the enforceable EU right by virtue of which the practitioner is a Swiss visiting practitioner”;

(iv)in paragraph 14—

(aa)sub-paragraphs (3) and (4) were omitted;

(bb)in sub-paragraph (6), after paragraph (a), there were inserted—

(aa)contains details of the existing contract or contracts on the basis of which the occasional pharmacy services will continue to be provided;

(ab)if the practitioner is a national of the United Kingdom or Switzerland, contains proof of nationality;

(ac)if the practitioner is not a national of the United Kingdom or Switzerland, contains proof of the enforceable EU right by virtue of which the practitioner is a Swiss visiting practitioner;;

(v)in paragraph 15(6), after paragraph (a), there were inserted—

(aa)ceases to have a valid contract to provide occasional pharmacy services, because the existing contract, or last of the existing contracts, on the basis of which the visiting practitioner was providing occasional pharmacy services, is terminated or otherwise expires; or.]

Textual Amendments

Commencement Information

I47Sch. 2 para. 45 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

European Professional CardU.K.

46.—(1) Sub-paragraph (2) applies where, immediately before [F13IP completion day]

(a)a person held a valid European professional card for establishment as a pharmacist in Great Britain, or

(b)the General Pharmaceutical Council was in receipt of a person's application for such a card, the application having been transmitted to it under Article 4d(1) of the Directive.

(2) For the purposes of registration in the register kept under the 2010 Order, the person is not required to resubmit any document or evidence held by the Council which is derived from the person's IMI file and which does not appear to the Council to have become invalid.

(3) In this paragraph—

(a)the Directive” means Directive 2005/36/EC of the European Parliament and of the Council of 7th September 2005 on the recognition of professional qualifications (OJ No L255, 30.09.2005, p 22), as it had effect immediately before [F14IP completion day];

(b)IMI file” has the meaning given by article 3 of the 2010 Order as it had effect immediately before [F15IP completion day].

Textual Amendments

Commencement Information

I48Sch. 2 para. 46 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

47.—(1) Where, immediately before [F16IP completion day], a person was entitled as mentioned in paragraph 15(2) of Schedule 2A to the 2010 Order, any provision made by or under that Order continues to apply in relation to the person without the amendments made by Part 1 of this Schedule to the provisions relating to the provision of occasional pharmacy services by holders of a European professional card.U.K.

(2) For the purposes of paragraph 15(4)(a) of Schedule 2A to the 2010 Order as it continues to apply by virtue of sub-paragraph (1)—

(a)a European professional card that was transmitted as mentioned in paragraph 15(1)(a) of that Schedule is to be treated as becoming invalid on the expiry of the period of 18 months beginning on the day on which it was transmitted;

(b)a European professional card that was issued as mentioned in paragraph 15(1)(b) of that Schedule is to be treated as becoming invalid on the expiry of the period of 12 months beginning with the day on which it was issued.

(3) The reference in sub-paragraph (1) to “the provisions relating to the provision of occasional pharmacy services by holders of a European professional card” is to the provisions listed in the following table.

InstrumentProvision relating to visiting practitioners
The 1968 Actsection 67E
section 69(1ZA)
section 71(7)
section 78(5) and (5A)
The 2010 Orderin article 3(1), the definitions of “competent authority”, “European professional card”, “General Systems Regulations”, “IMI”, “IMI file” and “registered pharmacist”
article 19(2)(d)
article 29(3)(a)
article 33A
article 36(3)
article 37(5)
article 38(2) and (4)
article 39(1)(c), (i) and (l)
article 43(5)(c), (8)(b) and (9)
in Schedule 2A, paragraphs 2 (except the definitions of “automatically recognised pharmacist”, “EPC holder” and “missing document”), 15 and 16
Medicines for Human Use (Clinical Trials) Regulations 2004regulation 2(1)
National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009regulation 2(1)
General Pharmaceutical Council (Registration) Rules 2010rule 18(1)(a) and (5)(a)(i)
rule 19(1), (4)(a) and (5)(b)
rule 20(3)(a)
General Pharmaceutical Council (Continuing Professional Development and Consequential Amendments) Rules 2011rule 5(2)(b) and (3)
rule 8(1)
rule 9(5)
rule 11(1)(a)
Human Medicines Regulations 2012regulation 8(1)
National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013regulation 2(1)

Textual Amendments

Commencement Information

I49Sch. 2 para. 47 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

48.—(1) A decision within article 39(1)(u) of the 2010 Order taken before [F17IP completion day], or a failure within article 39(1A) of that Order arising before [F17IP completion day], continues to be appealable for the purposes of article 40 of that Order (subject to the provisions of the Order) despite the revocation of article 39(1)(u) and (1A).U.K.

(2) In disposing of such an appeal (or a further appeal under article 41 of the 2010 Order), the powers of the Appeal Committee (or the relevant court) are, instead of those set out in article 40(7) (or 41(4)) of the 2010 Order, to—

(a)dismiss the appeal, or

(b)allow the appeal and—

(i)direct the Council to take such steps as the Committee (or the relevant court) thinks fit to draw the findings of the Committee (or court) to the attention of the European Commission;

(ii)direct that the person in respect of whom the decision was taken (or the failure arose) is to be treated, for the purposes of paragraph 45(1)(a), as a person who held a valid European professional card for establishment in Great Britain immediately before [F18IP completion day],

and, in the case of an appeal under article 41, to make such order as to costs (or, in Scotland, expenses) as the court thinks fit.

Textual Amendments

Commencement Information

I50Sch. 2 para. 48 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

IMI alertsU.K.

49.—(1) Where an alert has been sent by the General Pharmaceutical Council before [F19IP completion day] under regulation 67 of the European Union (Recognition of Professional Qualifications) Regulations 2015 (as they had effect before [F19IP completion day]), the decision to send the alert continues to be appealable for the purposes of article 40 of the 2010 Order (subject to the provisions of that Order) despite the revocation of article 39(1)(t).

(2) In disposing of such an appeal (or a further appeal under article 41 of the 2010 Order), the powers of the Appeal Committee (or the relevant court) are, instead of those set out in article 40(7) (or 41(4)) of the 2010 Order, to—

(a)dismiss the appeal, or

(b)allow the appeal F20...,

and, in the case of an appeal under article 41, to make such order as to costs (or, in Scotland, expenses) as the court thinks fit.

Textual Amendments

Commencement Information

I51Sch. 2 para. 49 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Interpretation of saved provisionsU.K.

50.  Where a provision continues to apply by virtue of this Part, it is to be read as if—

(a)in article 3(1) of the 2010 Order—

(i)there were substituted for the definition of “the Directive”—

the Directive” means Directive 2005/36/EC of the European Parliament and of the Council of 7th September 2005 on the recognition of professional qualifications (OJ No L255, 30.09.2005, p 22), and any reference in this Order to the Directive or to any provision of the Directive is a reference to the Directive, or to that provision, as it had effect immediately before [F21IP completion day];;

(ii)there were inserted at the appropriate place—

enforceable EU right” means a right recognised and available in domestic law, immediately before [F22IP completion day], by virtue of section 2(1) of the European Communities Act 1972;;

(iii)in the definition of “exempt person”, for paragraphs (a) to (c) there were substituted—

(a)a person who, immediately before [F23IP completion day], was a national of a relevant European State,

(b)a person who, immediately before [F23IP completion day], was a national of the United Kingdom and, at that time, was seeking access to, or pursuing, the profession of pharmacist or pharmacy technician by virtue of an enforceable EU right, or

(c)a person who, immediately before [F23IP completion day], was not a national of a relevant European State, but at that time was, by virtue of an enforceable EU right, entitled to be treated, for the purposes of access to and pursuit of the profession of pharmacist or pharmacy technician, no less favourably than a national of a relevant European State;;

(iv)in the definition of “General Systems Regulations” [F24(other than that definition as it continues to apply by virtue of paragraph 44A or 44B of this Part)], [F25at the end] there were inserted—

(a)in relation to anything done before [F26IP completion day], as they had effect at that time;

(b)otherwise, as (and only to the extent that) they have effect, on or after [F26IP completion day], in relation to an entitlement which arose before [F26IP completion day] or arises as a result of something done before [F26IP completion day];;

(b)in any reference to a relevant European State other than the United Kingdom, the words “other than the United Kingdom” were omitted.

Textual Amendments

Commencement Information

I52Sch. 2 para. 50 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)