Explanatory Memorandum for the Human Medicines (Amendment) (EU Exit) Regulations 2021 | Lecture notes Marketing

DExEU/EM/7-2018.2

EXPLANATORY MEMORANDUM TO

THE HUMAN MEDICINES (AMENDMENT) (EU EXIT) REGULATIONS 2021

2021 No. [XXXX]

1. Introduction

1.1 This Explanatory Memorandum has been prepared by the Department of Health and

Social Care and is laid before Parliament by Act.

1.2 This memorandum contains information for the Sifting Committees.

2. Purpose of the instrument

2.1 These Regulations amend the Human Medicines Regulations 2012 (“the HMRs”),

which govern the arrangements throughout the United Kingdom for the manufacture,

importation and marketing of medicinal products for human use. The Human

Medicines (Amendment etc.) (EU Exit) Regulations 2019 (“the 2019 Regulations”)

made an amendment to regulation 3(15) of the HMRs that was subsequently amended

by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (“the 2020

Regulations”), but regrettably this was ineffective due to a numbering error. These

Regulations correct that numbering error to restore the original drafting intention and

make consequential amendments to the provisions that contained the error.

3. Matters of special interest to Parliament

Matters of special interest to the Sifting Committees

3.1 This instrument is being laid for sifting by the Sifting Committees.

Matters relevant to Standing Orders Nos. 83P and 83T of the Standing Orders of the House

of Commons relating to Public Business (English Votes for English Laws)

3.2 As the instrument is subject to negative resolution procedure there are no matters

relevant to Standing Orders Nos. 83P and 83T of the Standing Orders of the House of

Commons relating to Public Business at this stage.

4. Extent and Territorial Application

4.1 The territorial extent of this instrument is the United Kingdom.

4.2 The territorial application of this instrument is the United Kingdom.

5. European Convention on Human Rights

5.1 As the instrument is subject to negative resolution procedure and does not amend

primary legislation no statement is required.

6. Legislative Context

6.1 Regulation 3 of the HMRs contains exemptions from the manufacturing and product

licensing requirements of the HMRs that relate to the manufacture or assembly of

medicines by doctors, dentists, nurses and midwives at the final stage of the medicines

supply chain – and related to those exemptions, there are provisions of regulation 3 that

deal with the packaging, labelling and leafleting requirements for the products covered

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EXPLANATORY MEMORANDUM TO

THE HUMAN MEDICINES (AMENDMENT) (EU EXIT) REGULATIONS 2021

2021 No. [XXXX]

1. Introduction 1.1 This Explanatory Memorandum has been prepared by the Department of Health and Social Care and is laid before Parliament by Act. 1.2 This memorandum contains information for the Sifting Committees. 2. Purpose of the instrument 2.1 These Regulations amend the Human Medicines Regulations 2012 (“the HMRs”), which govern the arrangements throughout the United Kingdom for the manufacture, importation and marketing of medicinal products for human use. The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (“the 2019 Regulations”) made an amendment to regulation 3(15) of the HMRs that was subsequently amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (“the 2020 Regulations”), but regrettably this was ineffective due to a numbering error. These Regulations correct that numbering error to restore the original drafting intention and make consequential amendments to the provisions that contained the error. 3. Matters of special interest to Parliament Matters of special interest to the Sifting Committees 3.1 This instrument is being laid for sifting by the Sifting Committees. Matters relevant to Standing Orders Nos. 83P and 83T of the Standing Orders of the House of Commons relating to Public Business (English Votes for English Laws) 3.2 As the instrument is subject to negative resolution procedure there are no matters relevant to Standing Orders Nos. 83P and 83T of the Standing Orders of the House of Commons relating to Public Business at this stage. 4. Extent and Territorial Application 4.1 The territorial extent of this instrument is the United Kingdom. 4.2 The territorial application of this instrument is the United Kingdom. 5. European Convention on Human Rights 5.1 As the instrument is subject to negative resolution procedure and does not amend primary legislation no statement is required. 6. Legislative Context 6.1 Regulation 3 of the HMRs contains exemptions from the manufacturing and product licensing requirements of the HMRs that relate to the manufacture or assembly of medicines by doctors, dentists, nurses and midwives at the final stage of the medicines supply chain – and related to those exemptions, there are provisions of regulation 3 that deal with the packaging, labelling and leafleting requirements for the products covered

2 by those exemptions. The 2019 Regulations made an amendment to an interpretation provision in paragraph (15) of regulation 3 that related to the repackaging, labelling and leafleting requirements in the case of products covered by a specified list of types of authorisations. Regrettably, because of a numbering error in the drafting of the amendment, introduced into the 2019 Regulations by the 2020 Regulations, the attempt to add “EU marketing authorisation” to the list of types of authorisations was ineffective. 6.2 As this Instrument will be printed to correct an error in SI 2020/1488 (which amended SI 2019/775, which amended SI 2012/1916) it will be issued free of charge to all known recipients of that Statutory Instrument.

7. Policy background What is being done and why? Making corrections to the UK statute book 7.1 This instrument corrects a numbering error in the 2020 Regulations, which were intended to add medicines which had received a marketing authorisation within the EU to the types of authorisation accepted within the interpretation of an authorised medicinal product. 7.2 This amendment, had it been effective would have ensured that at the end of the Implementation Period, the HMRs accurately reflected the regulatory situation across the UK. That is, with respect to Northern Ireland and the Northern Ireland Protocol, that medicines with an EU marketing authorisation would be authorised in Northern Ireland. 7.3 This instrument will provide the necessary updates to the HMRs to ensure that the error is corrected and the full range of medicines available within Northern Ireland are listed within the recognised types of approval for the purposes of Regulation 3. 8. European Union (Withdrawal) Act/Withdrawal of the United Kingdom from the European Union 8.1 This instrument is made using the powers in section 8C(1) of the European Union (Withdrawal) Act 2018, as it is correcting an error in an amendment that was made in order to implement the Northern Ireland Protocol. 8.2 In accordance with the requirements of EUWA the Minister has made the relevant statements as detailed in Part 2 of the Annex to this Explanatory Memorandum. 9. Consolidation 9.1 There are no plans to consolidate the legislation amended by this instrument. 10. Consultation Outcome 10.1 No formal consultation has taken place. 10.2 The devolved administrations have been engaged on these changes. 11. Guidance 11.1 The MHRA and the NIE will ensure that relevant professionals are aware of these changes and the regulatory approach until they are in place.

Annex

Statements under the European Union (Withdrawal) Act

Part 1 Table of Statements under the 2018 Act

This table sets out the statements that may be required under the 2018 Act. Statement Where the requirement sits To whom it applies What it requires Sifting Paragraphs 3(3), 3(7) and 17(3) and 17(7) of Schedule 7 Ministers of the Crown exercising sections 8(1), 9 and 23 (1) to make a Negative SI Explain why the instrument should be subject to the negative procedure and, if applicable, why they disagree with the recommendation(s) of the SLSC/Sifting Committees Appropriate- ness Sub-paragraph (2) of paragraph 28, Schedule 7 Ministers of the Crown exercising sections 8(1), 9 and 23(1) or jointly exercising powers in Schedule 2 A statement that the SI does no more than is appropriate. Good Reasons Sub-paragraph (3) of paragraph 28, Schedule 7 Ministers of the Crown exercising sections 8(1), 9 and 23(1) or jointly exercising powers in Schedule 2 Explain the good reasons for making the instrument and that what is being done is a reasonable course of action. Equalities Sub-paragraphs (4) and (5) of paragraph 28, Schedule 7 Ministers of the Crown exercising sections 8(1)e, 9 and 23(1) or jointly exercising powers in Schedule 2 Explain what, if any, amendment, repeals or revocations are being made to the Equalities Acts 2006 and 2010 and legislation made under them. State that the Minister has had due regard to the need to eliminate discrimination and other conduct prohibited under the Equality Act 2010. Explanations Sub-paragraph (6) of paragraph 28, Schedule 7 Ministers of the Crown exercising sections 8(1), 9 and 23(1) or jointly exercising powers in Schedule 2 In addition to the statutory obligation the Government has made a political commitment to include these statements alongside all EUWA SIs Explain the instrument, identify the relevant law before exit day, explain the instrument’s effect on retained EU law and give information about the purpose of the instrument, e.g., whether minor or technical changes only are intended to the EU retained law.

5 Criminal offences Sub-paragraphs (3) and (7) of paragraph 28, Schedule 7 Ministers of the Crown exercising sections 8(1), 9, and 23(1) or jointly exercising powers in Schedule 2 to create a criminal offence Set out the ‘good reasons’ for creating a criminal offence, and the penalty attached. Sub- delegation Paragraph 30, Schedule 7 Ministers of the Crown exercising sections 10(1), 12 and part 1 of Schedule 4 to create a legislative power exercisable not by a Minister of the Crown or a Devolved Authority by Statutory Instrument. State why it is appropriate to create such a sub-delegated power. Urgency Paragraph 34, Schedule 7 Ministers of the Crown using the urgent procedure in paragraphs 4 or 14, Schedule

Statement of the reasons for the Minister’s opinion that the SI is urgent. Explanations where amending regulations under 2(2) ECA 1972 Paragraph 14, Schedule 8 Anybody making an SI after exit day under powers outside the European Union (Withdrawal) Act 2018 which modifies subordinate legislation made under s. 2(2) ECA Statement explaining the good reasons for modifying the instrument made under s. 2(2) ECA, identifying the relevant law before exit day, and explaining the instrument’s effect on retained EU law. Scrutiny statement where amending regulations under 2(2) ECA 1972 Paragraph 15, Schedule 8 Anybody making an SI after exit day under powers outside the European Union (Withdrawal) Act 2018 which modifies subordinate legislation made under s. 2(2) ECA Statement setting out: a) the steps which the relevant authority has taken to make the draft instrument published in accordance with paragraph 16(2), Schedule 8 available to each House of Parliament, b) containing information about the relevant authority’s response to— (i) any recommendations made by a committee of either House of Parliament about the published draft instrument, and (ii) any other representations made to the relevant authority about the published draft instrument, and, c) containing any other information that the relevant authority considers appropriate in relation to the scrutiny of the instrument or draft instrument which is to be laid.

7 “In relation to the draft instrument, I, Minister of State for Health, Edward Argar, have had due regard to the need to eliminate discrimination, harassment, victimisation and any other conduct that is prohibited by or under the Equality Act 2010.”.

5. Explanations 5.1 The explanations statement has been made in section 2 of the main body of this Explanatory Memorandum.

Explanatory Memorandum for the Human Medicines (Amendment) (EU Exit) Regulations 2021, Lecture notes of Marketing

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Download Explanatory Memorandum for the Human Medicines (Amendment) (EU Exit) Regulations 2021 and more Lecture notes Marketing in PDF only on Docsity!

EXPLANATORY MEMORANDUM TO

THE HUMAN MEDICINES (AMENDMENT) (EU EXIT) REGULATIONS 2021

Annex

Statements under the European Union (Withdrawal) Act

Part 1

Table of Statements under the 2018 Act