OpenLegislation

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

S.I. 2019/585 · Made 14 March 2019 · Extends to Northern Ireland

Up to date with all changes known to legislation.gov.uk, revised to 31 December 2020.

Exiting The European Union

Health Care And Associated Professions

Professional Qualifications

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 M1.

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.

Annotations to the whole text

Marginal citations

M1

2018 c. 16.

Contents

  1. 1Citation and commencement
  2. 1AInterpretation: general
  3. 2Pharmacists
  4. 2AAdministrative cooperation under the EEA EFTA citizens’ rights agreement
  5. 2BEqual treatment and administrative co-operation under the Swiss citizen’s rights agreement
  6. 3Review of continued recognition of certain European qualifications
  7. Signature
  8. Schedule: Amendments relating to pharmacists in Northern Ireland
  9. Part 1: Amendment of the 1976 Order
  10. 1Interpretation
  11. 2Pharmacy (Northern Ireland) Order 1976
  12. 3Paragraph 3
  13. 4Paragraph 4
  14. 5Paragraph 5
  15. 6Paragraph 6
  16. 7Paragraph 7
  17. 8Paragraph 8
  18. 9Paragraph 9
  19. 10Paragraph 10
  20. 11Paragraph 11
  21. 12Paragraph 12
  22. 13Paragraph 13
  23. 14Paragraph 14
  24. 15Paragraph 15
  25. 16Paragraph 16
  26. 17Paragraph 17
  27. 18Paragraph 18
  28. 19Paragraph 19
  29. 20Paragraph 20
  30. 21Paragraph 21
  31. 22Paragraph 22
  32. 23Paragraph 23
  33. 24Paragraph 24
  34. Part 2: Amendment of other legislation
  35. 25Amendments
  36. 26Paragraph 26
  37. 27Paragraph 27
  38. 28Revocations
  39. Part 3: Transitional and saving provision relating to the amendments in Parts 1 and 2
  40. 29Pending applications
  41. 29ASwiss pharmacists: saving of old law
  42. 30Visiting practitioners from relevant European States – saving of old law for up to five years
  43. 31European professional card
  44. 32Paragraph 32
  45. 33Paragraph 33
  46. 34IMI Alerts
  47. 35Interpretation of Saved Provisions
  48. Explanatory note

1Citation and commencementI1

(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.

1AInterpretation: generalF1I1

In these Regulations—

  • “the 2007 Regulations” means the European Communities (Recognition of Professional Qualifications) Regulations 2007;

  • “the 2015 Regulations” means the European Union (Recognition of Professional Qualifications) Regulations 2015, 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 of regulation 1A of the European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019);

  • “the Council” means the Council of the Pharmaceutical Society of Northern Ireland;

  • “relevant applicant” means an individual—

    1. (a)

      who provides services in a regulated profession in the United Kingdom on a temporary and occasional basis on the basis of an existing contract,

    2. (b)

      who began providing, or begins to provide, the services mentioned in paragraph (a), either—

      1. (i)

        before IP completion day, in an employed or self-employed capacity, or

      2. (ii)

        on or after IP completion day, as an employee posted for the purpose of carrying on professional activities in the United Kingdom by their employer who is established in the United Kingdom or Switzerland,

    3. (c)

      who is a national of the United Kingdom or Switzerland, or a third country national, who was, immediately before IP completion day, by virtue of any enforceable EU right entitled to be treated no less favourably than a national of either the United Kingdom or Switzerland for the purposes of access to and pursuit of a regulated profession,

    4. (d)

      who is legally established in Switzerland for the purpose of pursuing the same profession there, and

    5. (e)

      who, if neither the regulated profession the individual wishes to access and pursue in the United Kingdom nor the education and training leading to it is regulated in Switzerland, has pursued that profession in Switzerland for at least two years during the ten years preceding the provision of services;

  • “same profession” means the profession for which the applicant is qualified in the applicant’s home State if the activities covered are comparable;

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

2PharmacistsI1

The Schedule contains–

(a)

amendments relating to pharmacists in Northern Ireland;

(b)

transitional and savings provision relating to those amendments.

2AAdministrative cooperation under the EEA EFTA citizens’ rights agreementI1F1

(1)

Where an individual has, before IP completion day, made an application falling under Article 26 of the EEA EFTA citizens’ rights agreement to a competent authority in Iceland, Norway or Liechtenstein for recognition of a professional qualification awarded or recognised by a competent authority in Northern Ireland, the Council must—

(a)

co-operate with the competent authority or assistance centre in Iceland, Norway or Liechtenstein, or with the individual (as the case may be), in accordance with—

(i)

Schedule 2D to the Pharmacy (Northern Ireland) Order 1976, as it had effect immediately before IP completion day;

(ii)

regulation 5(2) to (5) of the 2015 Regulations;

(b)

provide information to the competent authority in Iceland, Liechtenstein or Norway regarding disciplinary action or criminal sanctions taken, or any other serious, specific circumstances which are likely to have consequences for the pursuit of professional activities by that individual.

(2)

The Council must process information for the purposes of paragraph (1) in accordance with data protection legislation within the meaning of section 3(9) (terms relating to the processing of personal data) of the Data Protection Act 2018.

(3)

In this regulation, “EEA EFTA citizens’ rights agreement” means the Agreement signed at London on 2 April 2019 between Iceland, the Principality of Liechtenstein, the Kingdom of Norway and the United Kingdom of Great Britain and Northern Ireland on arrangements regarding citizens’ rights following the withdrawal of the United Kingdom from the European Union and the EEA Agreement.

2BEqual treatment and administrative co-operation under the Swiss citizen’s rights agreementF1I1

(1)

In dealing with a relevant applicant who provides services in the United Kingdom pursuant to paragraph 30 of the Schedule in relation to any matter, the Council must treat that person no less favourably than it would treat a native applicant (within the meaning given in regulation 2 of the 2007 Regulations) providing services in Northern Ireland in relation to that matter.

(2)

Where an individual is providing services as a pharmacist on a temporary and occasional basis in Switzerland pursuant to Article 23 of the Swiss citizens’ rights agreement, the Council must co-operate with and provide the competent authority in Switzerland with any information relevant to the legality of the individual’s establishment and good conduct, as well as the absence of any disciplinary or criminal sanctions of a professional nature, in accordance with paragraph 3 of Schedule 3 to the Pharmacy (Northern Ireland) Order 1976, as it applied immediately before IP completion day, or regulation 5(2), (3) and (4) of the 2007 Regulations (as the case may be).

(3)

Where an individual has made or makes an application falling within Article 31(1) or 32(1) or (5) of the Swiss citizens’ rights agreement to a competent authority in Switzerland for recognition of a professional qualification awarded or recognised by a competent authority in the United Kingdom, the Council must—

(a)

co-operate with the Swiss competent authority or contact point in Switzerland, or the individual (as the case may be), in accordance with Schedule 2D to the Pharmacy (Northern Ireland) Order 1976, as it applied immediately before IP completion day, or regulation 5(2), (5) and (6) of the 2007 Regulations (as the case may be), and

(b)

provide information to the competent authority in Switzerland regarding disciplinary action or criminal sanctions taken, or any other serious, specific circumstances which are likely to have consequences for the pursuit of professional activities by that individual.

(4)

The Council must process information for the purposes of paragraphs (2) and (3) in accordance with data protection legislation within the meaning given in section 3(9) (terms relating to the processing of personal data) of the Data Protection Act 2018.

(5)

In this paragraph, “competent authority”, in relation to Switzerland, has the meaning given in regulation 2(1) of the 2015 Regulations, as it had effect immediately before IP completion day.

3Review of continued recognition of certain European qualificationsI1

(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 F1IP 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).

Signature

Signed by authority of the Secretary of State for Health and Social Care.

Stephen Hammond

Minister of State,

Department of Health and Social Care

1InterpretationI1

(1)

In this Schedule, the “1976 Order” means the Pharmacy (Northern Ireland) Order 1976 M1.

(2)

The Interpretation Act (Northern Ireland) 1954 M2 applies to Part 3 of this Schedule as it applies to a Part of a Schedule to an Act of the Assembly.

2Pharmacy (Northern Ireland) Order 1976I1

The 1976 Order is amended as follows.

3I1

In Article 2(2) (interpretation) M1—

(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”.

4I1

In Article 4A (continuing professional development) M1, omit paragraphs (7)(c), (10)(b) and (14).

5I1

In Article 5 (regulations made by the Council: general) M1, omit paragraph (1A).

6I1

In Article 6 (the registers) M1—

(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.

7I1

In Article 8 (qualifications for registration) M1—

(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.”.

8I1

For Article 8A (registration by virtue of appropriate European diploma) M1, including the heading, substitute—

“Relevant European qualifications

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 F1IP 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.

Relevant European qualification: indication in the register

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.”.

9I1

In Article 8AA (supplementary provisions as to the necessary knowledge of English) M1, omit paragraphs (5) and (7).

10I1

Omit Article 8B (visiting pharmaceutical chemist from a relevant European State) M1.

11I1

Omit Article 8C (professional traineeships carried out in other relevant European States, etc.) M1.

12I1

Omit Article 8D (European professional card) M1.

13I1

In Article 9(2) (the registrar) M1, for “and, (c) and (d)” substitute “ and (c) ”.

14I1

In Article 11 (evidence of qualification to be registered) M1—

(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).

15I1

Omit Article 11ZZA (appeals: decisions in relation to alerts and European professional cards) M1.

16I1

Omit Article 11ZZB (appeals to the Council under Article 11ZZA) M1.

17I1

Omit Article 11ZA (recognition of qualification of exempt persons) M1.

18I1

In Article 11A (indemnity arrangements) M1, omit paragraph (12).

19I1

In Article 14(2A) (issue of certificates of registration and penalties for failure to surrender, or abuse of, certificates) M1, for “8A(1)” substitute “ 8ZA ”.

20I1

Omit Article 22A (the Directive: functions of competent authority, etc.) M1.

21I1

Omit Schedule 2A (table in respect of training in the former Czechoslovakia, the former Soviet Union or the former Yugoslavia) M1.

22I1

Omit Schedule 2B (visiting pharmaceutical chemist from a relevant European State) M1.

23I1

Omit Schedule 2C (Directive 2005/36/EC: European professional card) M1.

24I1

Omit Schedule 2D (the Directive: functions of the Society under Article 22A) M1.

25AmendmentsI1

In Article 63AA(3)(c) (persons providing pharmaceutical services) of F1the Health and Personal Social Services (Northern Ireland) Order 1972 M1, for “(qualification by European diploma)” substitute “ (relevant European qualification) ”.

26

In regulation 6(12) (pharmaceutical list) of the Pharmaceutical Services Regulations (Northern Ireland) 1997 M1, for “(qualification by European diploma)” substitute “ (relevant European qualification) ”.

27I1

(1)

The Council of the Pharmaceutical Society of Northern Ireland (Continuing Professional Development) Regulations 2012 M1 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.

28RevocationsI1

The following instruments are revoked—

(a)

the European Qualifications (Pharmacy) Regulations (Northern Ireland) 2008 M1,

(b)

the Registration of Pharmaceutical Chemists (Exempt Persons) Regulations (Northern Ireland) 2008 M2.

29Pending applicationsI1

Where an application for registration, or retention, in a part of the register kept under the 1976 Order is received before F1IP 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.

29ASwiss pharmacists: saving of old lawF1I1

(1)

Where an application for registration in the register mentioned in Article 6(1)(a) of the 1976 Order is received from a Swiss pharmacist before the end of the period of four years beginning with the day immediately after IP completion day, any provision made by or under the 1976 Order (except for the provision contained in Schedule 2C to the Order) continues to apply in relation to the application without the amendments Parts 1 and 2 of this Schedule make to the provisions mentioned in sub-paragraph (3) (but subject to the modifications to the 1976 Order and the Registration Regulations specified in sub-paragraphs (4) and (5)).

(2)

For the purposes of this paragraph, “Swiss pharmacist” means a qualifying applicant (within the meaning given in regulation 1A of the European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019) who had not, before IP completion day, made an application in the register mentioned in Article 6(1)(a) of the 1976 Order.

(3)

The provisions mentioned in sub-paragraph (1) are—

(a)

in the 1976 Order—

(i)

in Article 2(2), the definitions of “competent authorities”, “the Directive”, “General Systems Regulations”, and “relevant European State”,

(ii)

Article 8,

(iii)

Article 8A,

(iv)

Article 8AA,

(v)

Article 8C,

(vi)

Article 11,

(vii)

Article 11ZA,

(viii)

Article 14(2A),

(ix)

Schedule 2A;

(b)

Article 63AA(3)(c) of the Health and Personal Social Services (Northern Ireland) Order 1972;

(c)

the European Qualifications (Pharmacy) Regulations (Northern Ireland) 2008;

(d)

the Registration Regulations 2008.

(4)

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

(a)

Article 2(2) is to have effect as if at the end of the definition of “General Systems Regulations” 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)”;

(b)

Article 8(2)(c) is to have effect as if, in the words before paragraph (i), the reference to an exempt person were a reference to a Swiss pharmacist within the meaning given in this paragraph of this Schedule;

(c)

Article 8AA(7) is to have effect as if the reference to an exempt person were a reference to a Swiss pharmacist within the meaning given in this paragraph of this Schedule;

(5)

The modifications to the Registration Regulations mentioned in sub-paragraph (1) are that regulation 2 is to have effect as if—

(a)

in paragraph (1) for “an exempt person” there were substituted “a Swiss pharmacist (within the meaning given in paragraph 29A of the Schedule to the European Qualifications (Pharmacists) (Amendment etc.) (EU Exit) Regulations (Northern Ireland) 2019)”;

(b)

for paragraph (2), there were substituted—

“(2)

Proof that E is a national of the United Kingdom or Switzerland or (where E is not a national of the United Kingdom or Switzerland) proof of the enforceable EU right by virtue of which E is a Swiss pharmacist.”;

(c)

any reference in paragraphs (3) to (6) to “E’s attesting State” were a reference to Switzerland.

(6)

In this paragraph, “the Registration Regulations” means the Registration of Pharmaceutical Chemists (Exempt Persons) Regulations (Northern Ireland) 2008.

30Visiting practitioners from relevant European States – saving of old law for up to five yearsF6I1

(1)

Where, immediately before F1IP 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 F2(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 F3IP completion day (and, accordingly, the entitlement lapses at the end of the period mentioned in paragraph 8(1) or (2) of that Schedule).

F4(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—

    1. (a)

      a national of the United Kingdom,

    2. (b)

      a national of Switzerland, or

    3. (c)

      a 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—

    1. (a)

      the period of five years beginning with IP completion day, or

    2. (b)

      if 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.

InstrumentProvisions relating to visiting practitioners
The 1976 OrderIn 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) 2012Regulation 2(7)(b)(ii)
Regulation 3(3)
Regulation 4(1)(f)(ii)
F5(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”.

31European professional cardI1

(1)

Sub-paragraph (2) applies where, immediately before F1IP 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 F2IP 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.

32I1

(1)

Where immediately before F1IP 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.

InstrumentProvisions relating to visiting practitioners holding a European professional card
The 1976 OrderIn Article 2(2), the definitions of “competent authorities”, “European professional card”, “General Systems Regulations”, “IMI”, “IMI file”, “registered”, “relevant European State” and “registered person”
Article 4A(7)(c), (10)(b) and (14)
Article 5(1A)
Article 6(1)
Article 8B
Article 8D
Article 9(2)
In Schedule 2C, paragraphs 2 (except the definitions of “EPC holder” and “missing document”), 15 and 16
The Council of the Pharmaceutical Society of Northern Ireland (Continuing Professional Development) Regulations (Northern Ireland) 2012Regulation 2(7)(b)(ii)
Regulation 3(3)
Regulation 4(1)(f)(ii)

33I1

(1)

A decision within Article 11ZZA(b) of the 1976 Order taken before exit day, or a failure within Article 11ZZA(c) of that Order arising before F1IP completion day, continues to be appealable for the purposes of Article 11ZZB of that Order (subject to the provisions of the Order) despite the revocation of Article 11ZZA(b) and 11ZZA(c).

(2)

In disposing of such an appeal, the powers of the Council are, instead of those set out in Article 11ZZB(4), to—

(a)

dismiss the appeal;

(b)

allow the appeal and direct the Society to take such steps as the Council thinks fit to draw the findings of the Council to the European Commission; or

(c)

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 31(1)(a), as a person who held a valid European professional card for establishment as a pharmaceutical chemist in Northern Ireland immediately before F2IP completion day.

34IMI AlertsI1

(1)

Where an alert has been sent by the Society before F1IP completion day under regulation 67 of the European Union (Recognition of Professional Qualifications) Regulations 2015(a) (as they had effect before IP completion day), the decision to send the alert continues to be appealable for the purposes of Article 11ZZA of the 1976 Order (subject to the provisions of that Order) despite the revocation of Article 11ZZB.

(2)

In disposing of such an appeal, the powers of the Council are, instead of those set out in Article 11ZZB(4), to—

(a)

dismiss the appeal, or

(b)

allow the appeal and direct the Society to take such steps as the Council thinks fit to draw the findings of the Council to the attention of the European Commission.

35Interpretation of Saved ProvisionsI1

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

(a)

in Article 2(2) of the 1976 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 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 F1IP completion day;”;

(ii)

there were inserted at the appropriate place—

““enforceable EU right” means a right recognised and available in domestic law, immediately before IP 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 IP completion day, was a national of a relevant European State,

(b)

a person who, immediately before IP completion day, was a national of the United Kingdom and, at that time, was seeking access to, or pursing, the profession of pharmacy by virtue of an enforceable EU right, or

(c)

a person who, immediately before IP 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 pharmacy, no less favourably than a national of relevant European State;”;

(iv)

in the definition of “General Systems Regulations”, after “S.I. 2015/2059” there were inserted—

“(a)

in relation to anything done before IP completion day, as they had effect at that time;

(b)

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

Explanatory note

(This note is not part of the Regulations)

These Regulations are made in exercise of the powers in the European Union (Withdrawal) Act 2018 (c.16) in order to address failures of domestic legislation to operate effectively and other deficiencies arising from the withdrawal of the United Kingdom from the European Union.

These Regulations amend legislation concerned with the regulation of pharmacy professionals in Northern Ireland.

They amend the Health and Personal Social Services (Northern Ireland) Order 1972 (S.I. 1972/1265), the Pharmacy (Northern Ireland) Order 1976 (S.R. 1976/1213 (N.I. 22)), the Pharmaceutical Services Regulations (Northern Ireland) 1997 (S.R. 1997/381) and the Council of Pharmaceutical Society of Northern Ireland (Continuing Professional Development) Regulations 2012/312. They revoke the European Qualifications (Pharmacy) Regulations (Northern Ireland) 2008 (S.R. 2008/192) and the Registration of Pharmaceutical Chemists (Exempt Persons) Regulations (Northern Ireland) 2008 (S.R. 2008/193).

Regulation 3 requires the Secretary of State to perform a review of provisions dealing with recognition of European Union qualifications within the Regulations. The Secretary of State is also required to produce and publish the conclusions of the review.

Part 1 of the Schedule removes rights and obligations under Directive 2005/36/EC (“the Directive”. The Directive is concerned with the recognition of professional qualifications across the European Union, including the recognition of pharmacists.

Part 1 of the Schedule removes provisions currently dealing with registration of and registers for “visiting” practitioners from relevant European States. “Visiting” practitioners provide services on a temporary and occasional basis, rather than becoming established in their profession in the UK. Part 3 of the Schedule saves certain provisions relating to “visiting” practitioners so that those who are entitled and have provided all documentation required to acquire that entitlement, before exit day, or have a pending application as at exit day, are dealt with under the current legislation. The savings provisions do not permit renewals of registrations under the “visiting” system.

Part 1 of the Schedule omits the definitions for and removes references to “exempt person” and “General Systems Regulations”. An “exempt person” is a person with certain rights under European Union legislation. These rights will no longer be available in the UK after exit day. The “General Systems Regulations” currently provide a domestic legislative basis for recognition of certain European qualifications. They also provide for regulators to require individuals to undertake compensatory measures and/or adaption periods where European qualifications fall short of the standards required by the Pharmaceutical Society of Northern Ireland (“the PSNI”). After exit day PSNI will not refer to the amended “General Systems Regulations” for new registrations.

Part 1 of the Schedule provides that qualifications and diplomas issued by relevant European States and currently recognised as giving automatic recognition in other relevant European States, will be qualifications enabling registration as a pharmaceutical chemist, unless a particular qualification or diploma has been designated by the registrar. Amendments provide that such designation will be subject to approval by the Department.

Part 1 of the Schedule removes or amends provisions giving those with rights under European legislation special treatment in relation to fees for registration, indemnity provisions and language testing requirements.

Part 1 of the Schedule omits references to “Directive 2002/58/EC” Directive 2002/58/EC is concerned with privacy and electronic communications. In the same part of these Schedules references to “the Directive” have been omitted or amended where required. The UK will no longer be subject to obligations imposed by Directives after exit day.

Part 1 of the Schedule also removes or amends (where required) references to “competent authority”. A competent authority is an authority or body within a relevant European State that has obligations or rights under the Directive to receive or issue evidence and information connected to qualifications, and to receive applications and take decisions under the Directive. In NI the Pharmaceutical Society for Northern Ireland holds this status. Competent authorities in the UK will no longer have rights and obligations under “the Directive” after exit day.

Part 1 of the Schedule removes references to the “European professional card” or “EPC”; “IMI”, and “IMI file”. The EPC is a system of professional qualification validation operated by the European Commission. The IMI is the Internal Market Information system and is the digital system used to process and communicate EPC information and other information about health and social care professionals (e.g. fitness to practice decisions), and an IMI file is a file held on that system. The UK will no longer have access to IMI after exit day, so it will no longer be able to offer or recognise new EPCs or pass on or accept other information via the IMI system.

Part 1 of the Schedule removes references to “national”. Post-exit eligibility for registration will depend on where the qualification is from as opposed to the nationality of the professional.

Part 2 amends and revokes legislation concerned with the regulation of pharmacy professionals in Northern Ireland.

Part 3 of the Schedule saves pending applications in relation to registration made before exit day. Various savings are also made to provide that pre-exit day legislation continues to apply so far as is practically possible after exit day for those who were registered before exit day, or whose applications were pending on exit day.

Part 3 of the Schedule deals with transitional and saving provisions to allow for continued appeals against EPC decisions. The provisions allow individuals to appeal, after exit day against EPC decisions made before exit day and that are within pre-exit day appeal periods, to the PSNI against the effect of the EPC decisions. The PSNI is also obliged to give effect to the decision as far as practically possible without access to IMI. Part 3 of the Schedule does not preserve EPC appeal rights as this is dealt within the Part 1 provisions of the Schedule.

Part 3 of the Schedule contains provisions to allow appeals against “IMI alerts”. An IMI alert is an alert issued though the IMI system about the fitness to practice of a health or social care professional, to relevant European States. Although the United Kingdom's access to IMI will cease after exit day the regulator will be obliged to notify the European Commission by other means of the outcome of the appeal. Any individual who has an alert issued against them that is still within pre-exit day appeal periods after exit day will be permitted to appeal to the relevant Registering body in the UK against the effect of the alert.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private or voluntary sector is foreseen.