The European Qualifications (Pharmacists) (Amendment etc.) (EU Exit) Regulations (Northern Ireland) 2019

Made: 14th March 2019

Coming into force in accordance with regulation 1

The Secretary of State makes these Regulations in exercise of the powers conferred by section 8(1) of, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018 .

In accordance with paragraph 1(1) of Schedule 7 to that Act, a draft of this instrument has been laid before and approved by a resolution of each House of Parliament.

Citation and commencement

1

• (1) These Regulations may be cited as the European Qualifications (Pharmacists) (Amendment etc.) (EU Exit) Regulations (Northern Ireland) 2019.

• (2) These Regulations come into force on exit day.

Pharmacists

2

The Schedule contains–

• (a) amendments relating to pharmacists in Northern Ireland;

• (b) transitional and savings provision relating to those amendments.

Review of continued recognition of certain European qualifications

3

• (1) The Secretary of State must, after the end of the period of two years beginning with the day on which these Regulations come into force—

• (a) carry out a review of the operation of the provision contained in Article 8(2)(c), (2B) and (2C) of the Pharmacy (Northern Ireland) Order 1976 (which concerns the recognition to be given to certain European qualifications after IP completion day) as substituted and inserted by these Regulations;

• (b) set out the conclusions of the review in a report;

• (c) publish the report.

• (2) The report must be published within the period of six months beginning with the day after the end of the period referred to in paragraph (1).

SCHEDULE — Amendments relating to pharmacists in Northern Ireland

PART 1 — Amendment of the 1976 Order

Interpretation

1

• (1) In this Schedule, the “1976 Order” means the Pharmacy (Northern Ireland) Order 1976 .

• (2) The Interpretation Act (Northern Ireland) 1954 applies to Part 3 of this Schedule as it applies to a Part of a Schedule to an Act of the Assembly.

Pharmacy (Northern Ireland) Order 1976

2

The 1976 Order is amended as follows.

3

In Article 2(2) (interpretation) —

• (a) omit the definitions of “competent authorities”, “Directive 2002/58/EC”, “the Directive”, “European professional card”, “exempt person”, “General Systems Regulations”; “IMI”, “IMI file”, “national”, “reference date”, “relevant European State” and “third country”;

• (b) in the definition of “registered”, omit “visiting pharmaceutical chemist from a relevant European State”;

• (c) in the definition of “registered person”, omit “, visiting pharmaceutical chemist from a relevant European State”.

4

In Article 4A (continuing professional development) , omit paragraphs (7)(c), (10)(b) and (14).

5

In Article 5 (regulations made by the Council: general) , omit paragraph (1A).

6

In Article 6 (the registers) —

• (a) in paragraph (1), omit “, and in relation to the register mentioned in sub-paragraph (d) there shall be kept,”;

• (b) after paragraph (1)(b), insert “ and ”;

• (c) omit paragraph (1)(d) and the “and” before it.

7

In Article 8 (qualifications for registration) —

• (a) for paragraph (2)(c), substitute—

(c) every person who holds a relevant European qualification.

• (b) after paragraph (2A), insert—

(2B) In paragraph (2)(c), “a relevant European qualification” means a qualification that falls within Article 8A (relevant European qualifications) and has not been designated by the registrar for the purposes of this paragraph. (2C) The registrar— (a) may designate a qualification for the purposes of paragraph (2B) only with the approval of the Department; (b) must maintain and publish a list of the qualifications that are so designated.

8

For Article 8A (registration by virtue of appropriate European diploma) , including the heading, substitute—

(8A) (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 this Article— (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, p22); and references in this Article to the Directive or to a provision of the Directive is a reference to the Directive, or to that provision, as it had effect immediately before IP completion day; (b) “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; (c) “relevant European State” means an EEA State or Switzerland. (8ZA) Where a person is registered by virtue of Article 8(2)(c), an indication that the person has been registered in respect of a relevant European qualification shall be entered in the register against the person's name.

9

In Article 8AA (supplementary provisions as to the necessary knowledge of English) , omit paragraphs (5) and (7).

10

Omit Article 8B (visiting pharmaceutical chemist from a relevant European State) .

11

Omit Article 8C (professional traineeships carried out in other relevant European States, etc.) .

12

Omit Article 8D (European professional card) .

13

In Article 9(2) (the registrar) , for “and, (c) and (d)” substitute “ and (c) ”.

14

In Article 11 (evidence of qualification to be registered) —

• (a) after paragraph (1) insert—

(1ZA) Article 8A does not restrict what may otherwise be done by the registrar under paragraph (1) in order to be satisfied as referred to in that paragraph.

• (b) omit paragraph (1A).

15

Omit Article 11ZZA (appeals: decisions in relation to alerts and European professional cards) .

16

Omit Article 11ZZB (appeals to the Council under Article 11ZZA) .

17

Omit Article 11ZA (recognition of qualification of exempt persons) .

18

In Article 11A (indemnity arrangements) , omit paragraph (12).

19

In Article 14(2A) (issue of certificates of registration and penalties for failure to surrender, or abuse of, certificates) , for “8A(1)” substitute “ 8ZA ”.

20

Omit Article 22A (the Directive: functions of competent authority, etc.) .

21

Omit Schedule 2A (table in respect of training in the former Czechoslovakia, the former Soviet Union or the former Yugoslavia) .

22

Omit Schedule 2B (visiting pharmaceutical chemist from a relevant European State) .

23

Omit Schedule 2C (Directive 2005/36/EC: European professional card) .

24

Omit Schedule 2D (the Directive: functions of the Society under Article 22A) .

PART 2 — Amendment of other legislation

Amendments

25

In Article 63AA(3)(c) (persons providing pharmaceutical services) of the Health and Personal Social Services (Northern Ireland) Order 1972 , for “(qualification by European diploma)” substitute “ (relevant European qualification) ”.

26

In regulation 6(12) (pharmaceutical list) of the Pharmaceutical Services Regulations (Northern Ireland) 1997 , for “(qualification by European diploma)” substitute “ (relevant European qualification) ”.

27

• (1) The Council of the Pharmaceutical Society of Northern Ireland (Continuing Professional Development) Regulations 2012 are amended as follows.

• (2) In regulation 2 (failure to comply with the CPD framework), omit paragraph (7)(b)(ii) and the “or” before it.

• (3) In regulation 3 (steps which the registrar may take), omit paragraph (3).

• (4) In regulation 4 (remedial measures), omit paragraph (1)(f)(ii) and the “or” before it.

Revocations

28

The following instruments are revoked—

• (a) the European Qualifications (Pharmacy) Regulations (Northern Ireland) 2008 ,

• (b) the Registration of Pharmaceutical Chemists (Exempt Persons) Regulations (Northern Ireland) 2008 .

PART 3 — Transitional and saving provision relating to the amendments in Parts 1 and 2

Pending applications

29

Where an application for registration, or retention, in a part of the register kept under the 1976 Order is received before IP completion day, any provision made by or under that Order (except for provision contained in Schedule 2C to the Order) continues to apply in relation to the application (including any appeal arising from it) without the amendments made by Part 1 or 2 of this Schedule.

Visiting practitioners from relevant European States – saving of old law for up to one year

30

• (1) Where, immediately before IP completion day—

• (a) a visiting practitioner was entitled under paragraph 4 or 7 of Schedule 2B to the 1976 Order to provide occasional pharmacy services, or

• (b) the registrar was in receipt of the required documents (within the meaning of paragraph 5 of that Schedule) from a visiting practitioner seeking to acquire that entitlement,

any provision made by an Act or instrument amended by Part 1 or 2 of this Schedule continues to apply in relation to the practitioner without the amendments that Part 1 or 2 of this Schedule makes to the provisions relating to visiting practitioners from relevant European States (but subject, in the case of a Swiss visiting practitioner, to the modifications to the 1976 Order specified in sub-paragraph (4)).

• (2) But a visiting practitioner's entitlement does not continue (or further continue) under paragraph 7 of Schedule 2B to the 1976 Order on or after IP completion day (and, accordingly, the entitlement lapses at the end of the period mentioned in paragraph 8(1) or (2) of that Schedule).

• (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 7 of Schedule 2B to the 1976 Order after the end of the visiting practitioner transitional period (and, accordingly, the entitlement lapses at the end of the period mentioned in paragraph 8(1) or (2) of that Schedule).

• (2C) In this paragraph—

• “Swiss visiting practitioner” means a visiting practitioner who is—a national of the United Kingdom,a national of Switzerland, ora third country national, who was, immediately before IP completion day, by virtue of an enforceable EU right entitled to be treated, for the purposes of access to and pursuit of a particular profession, no less favourably than a national of either of those states;

• “visiting practitioner transitional period” means—the period of five years beginning with IP completion day, orif the period in paragraph (a) is extended in accordance with Article 23(2) of the Swiss citizens’ rights agreement, that period as extended.

• (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.

Instrument	Provisions relating to visiting practitioners
The 1976 Order	In Article 2(2), the definitions of “competent authorities”, “exempt person”, “General Systems Regulations”, “national”, “registered”, “relevant European State” and “registered person”
	Article 4A(7)(c), (10)(b) and (14)
	Article 5(1A)
	Article 6(1)
	Article 8B
	Article 9(2)
	Article 11A(12)
	Schedule 2B
The Council of the Pharmaceutical Society of Northern Ireland (Continuing Professional Development) Regulations (Northern Ireland) 2012	Regulation 2(7)(b)(ii)
	Regulation 3(3)
	Regulation 4(1)(f)(ii)

• (4) The modifications to the 1976 Order mentioned in sub-paragraph (1) are—

• (a) Article 2(2) is to be read as if, in the definition of “competent authorities” for “a relevant European State” there were substituted “Switzerland”;

• (b) Article 4A(14) is to be read as if for the words from “the relevant” to the end there were substituted “Switzerland”;

• (c) Schedule 2B is to be read as if—

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

(1) This Schedule applies to a Swiss visiting practitioner (within the meaning given in paragraph 30(2C) of the Schedule to the European Qualifications (Pharmacists) (Amendment etc.) (EU Exit) Regulations (Northern Ireland) 2019) who is lawfully established as a pharmacist in Switzerland.

• (ii) in paragraph 2—

• (aa) before sub-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;

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

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

• (dd) in sub-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 5(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 7(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;

, and

• (v) in paragraph 8(5), after paragraph (a), there were inserted—

(aa) 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

European professional card

31

• (1) Sub-paragraph (2) applies where, immediately before IP completion day—

• (a) a person held a valid European professional card for establishment as a pharmaceutical chemist in Northern Ireland, or

• (b) the Society 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 1976 Order, the person is not required to resubmit any document or evidence held by the Society which is derived from the person's IMI file and which does not appear to the Society 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 IP completion day;

• (b) “IMI file” has the meaning given by Article 2 of the 1976 Order as it had effect immediately before IP completion day.

32

• (1) Where immediately before IP completion day, a person was entitled as mentioned in paragraph 15(2) of Schedule 2C to the 1976 Order, any provision made by or under that Order continues to apply in relation to the person without the amendments made by Part 1 or 2 of this Schedule to the provisions relating to the provision of occasional pharmacy services by holders of a European professional card.

• (2) For the purposes of paragraph 15(4)(a) of Schedule 2C to the 1976 Order as it continues to apply by virtue of sub-paragraph (1), 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 with the day on which it was transmitted.

• (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.