Search Legislation

The Human Medicines Regulations 2012

Changes over time for: PART 4

 Help about opening options

Alternative versions:

Changes to legislation:

The Human Medicines Regulations 2012, PART 4 is up to date with all changes known to be in force on or before 25 December 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations. Help about Changes to Legislation

Close

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.

View outstanding changes

Changes and effects yet to be applied to Schedule 34 Part 4:

Changes and effects yet to be applied to the whole Instrument associated Parts and Chapters:

Whole provisions yet to be inserted into this Instrument (including any effects on those provisions):

PART 4U.K.The Medicines for Human Use (Clinical Trials) Regulations 2004

52.  The Medicines for Human Use (Clinical Trials) Regulations 2004 M1 are amended as follows.U.K.

Marginal Citations

M1S.I. 2004/1031, as amended by S.I. 2005/2754. There are other amendments, but none is relevant.

53.  In regulation 2(1) (interpretation)—U.K.

(a)before the definition “the Act” insert the following definition—

the 2012 Regulations” means the Human Medicines Regulations 2012;;

(b)for the definition “appropriate committee” substitute—

appropriate committee” for the purposes of any provision of these Regulations under which a function falls to be performed means whichever the licensing authority considers to be appropriate of—

(a)

the Commission on Human Medicines; or

(b)

an expert committee appointed by the licensing authority;;

(c)insert in the appropriate position in alphabetical order the following definition—

the Commission on Human Medicines” means the Commission on Human Medicines within the meaning of regulation 9 of the 2012 Regulations;;

(d)in the definition “licensing authority” for “section 6 of the Act” substitute “ regulation 6 of the 2012 Regulations ”;

(e)for sub-paragraph (a) of the definition “marketing authorisation” substitute—

(a)a UK marketing authorisation granted by the licensing authority under the 2012 Regulations,; and

(f)for the definition “medicinal product” substitute—

medicinal product” means a medicinal product within the meaning of regulation 2(1) of the 2012 Regulations.

54.  In regulation 4(3) (responsibility for functions under the Directive) for “the Act” substitute “ the 2012 Regulations ”.U.K.

55.  In regulation 19(10) (authorisation procedure for clinical trials involving medicinal products for gene therapy etc) omit “established by section 2A of the Act”.U.K.

56.  In regulation 46(2)(c) (labelling) for words from “Schedule 5” to the end of the sub-paragraph substitute “ Part 13 of the 2012 Regulations that apply in relation to medicinal products sold or supplied in accordance with a prescription given by a person who is an appropriate practitioner within the meaning of regulation 214(3) to (6) of those Regulations ”.U.K.

57.  In regulation 47 (application of enforcement provisions of the Act)—U.K.

(a)for “the Act” in the heading substitute “ the 2012 Regulations ”; and

(b)for paragraph (1) substitute—

(1) Regulations 2, 8(1), 322, 323(1), 324(1), 325 to 330, 332 to 339, 343 and Schedule 31 of the 2012 Regulations (“those provisions”) shall apply for the purposes of these Regulations as they apply for the purposes of the 2012 Regulations, but with the modifications specified in Schedule 9, and any reference in those provisions to the 2012 Regulations includes a reference to these Regulations.; and

(c)after paragraph (2) insert the following paragraph—

(3) In those provisions as applying by virtue of paragraph (1), any reference to, or relating to, a requirement, a power, a function, a right, a duty, an entitlement, or a protection shall be read as a reference to, or relating to, that requirement, power, function, right, duty, entitlement, or protection as applied by this regulation..

58.  In regulation 48(5) (infringement notices) for “sections 108 to 110 of the Act” substitute “ regulation 323(1) or 324(1) of the 2012 Regulations ”.U.K.

59.  In regulation 49(5) (offences) for “the Act” substitute “ the 2012 Regulations ”.U.K.

60.  In regulation 53(3) (construction of references to specified publications) for “section 103(1) of the Act” substitute “ regulation 321(1) of the 2012 Regulations ”.U.K.

61.  In paragraph 4(2) of Schedule 5 (procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trial authorisations and the suspension or termination of clinical trials)—U.K.

(a)in sub-paragraph (a), for paragraphs (i) to (iii) substitute—

(i)the Commission on Human Medicines,

(ii)an expert committee appointed by the licensing authority,

(iii)an expert advisory group within the meaning of regulation 14 of the 2012 Regulations,

(iv)the British Pharmacopoeia Commission referred to in regulation 11 of the 2012 Regulations, or any of its sub-committees,

(v)the Medicines Commission formerly established under section 2 of the Act, or any of its committees,

(vi)the Advisory Board on the Registration of Homoeopathic Products formerly established under section 4 of the Act, or any of its sub-committees, or

(vii)the Herbal Medicines Advisory Committee formerly established under section 4 of the Act, or any of its sub-committees, and; and

(b)in sub-paragraph (b) after “Crown” insert “ , the Scottish Ministers, the Welsh Ministers or a Northern Ireland Minister ”.

62.  In Schedule 7 (standard provisions for manufacturing authorisations)—U.K.

(a)in Part 2—

(i)in paragraph 5 for “the Act” substitute “ the 2012 Regulations ”,

(ii)in paragraph 9 for “the Act or any regulations under the Act” substitute “ or the 2012 Regulations ”, and

(iii)in paragraph 13—

(aa)for “Part II of the Act” substitute “ Parts 3 to 8 of the 2012 Regulations ”, and

(bb)for “the Act” in the second place where it occurs substitute “ the 2012 Regulations ”; and

(b)in Part 3—

(i)in paragraph 6 for “the Act” in the first place where it occurs substitute “ the 2012 Regulations ”, and

(ii)in paragraph 8—

(aa)for “Part II of the Act” substitute “ Parts 3 to 8 of the 2012 Regulations ”, and

(bb)for “the Act” in the second place where it occurs substitute “ the 2012 Regulations ”.

63.  In paragraph 5(2) of Schedule 8 (procedural provisions relating to proposals to grant, refuse to grant, vary, suspend or revoke manufacturing authorisations)—U.K.

(a)in sub-paragraph (a), for paragraphs (i) to (iii) substitute—

(i)the Commission on Human Medicines,

(ii)an expert committee appointed by the licensing authority,

(iii)an expert advisory group within the meaning of regulation 14 of the 2012 Regulations,

(iv)the British Pharmacopoeia Commission referred to in regulation 11 of the 2012 Regulations, or any of its sub-committees,

(v)the Medicines Commission formerly established under section 2 of the Act, or any of its committees,

(vi)the Advisory Board on the Registration of Homoeopathic Products formerly established under section 4 of the Act, or any of its sub-committees, or

(vii)the Herbal Medicines Advisory Committee formerly established under section 4 of the Act, or any of its sub-committees, and; and

(b)in sub-paragraph (b) after “Crown” insert “ , the Scottish Ministers, the Welsh Ministers or a Northern Ireland Minister ”.

64.  For Schedule 9 substitute the following Schedule—U.K.

Regulation 47(1)

SCHEDULE 9U.K.MODIFICATIONS OF THE ENFORCEMENT PROVISIONS OF THE 2012 REGULATIONS SUBJECT TO WHICH THOSE PROVISIONS ARE APPLIED FOR THE PURPOSES OF THESE REGULATIONS

1.  The modifications of the 2012 Regulations mentioned in regulation 47 are as follows.

2.  In regulation 2 (medicinal products)—

(a)at the beginning of paragraph (1) insert “ Subject to paragraph (3), ”; and

(b)after paragraph (2) insert the following paragraph—

(3) Medicinal product” includes any investigational medicinal product..

2.  In regulation 8(1) (interpretation)—

(a)the definition “assemble” is substituted by the definition of that expression in regulation 2(1) of these Regulations; and

(b)there is inserted in the appropriate position in alphabetical order a definition “container” in the same terms as the definition of that expression in regulation 2(1) of these Regulations; and

(c)the definition “qualified person” is substituted by the definition of that expression in regulation 2(1) of these Regulations.

3.  In regulation 322(1) (validity of decisions and proceedings) omit “or” and insert a comma before “ 8 (Article 126a authorisations) ”, and after those words insert “ or the Clinical Trials Regulations ”.

4.  In regulation 325(1) (rights of entry) insert after sub-paragraph (b) the following sub-paragraph—

(ba)in order to verify any statement contained in an application or request for an authorisation under the Clinical Trials Regulations;.

5.(1) Regulation 327 (powers of inspection, sampling and seizure) is amended as follows.

(2) In paragraph (1)—

(a)after sub-paragraph (b) omit “; or”;

(b)after sub-paragraph (c) insert “ ; or ” and the following sub-paragraph—

(d)in order to verify any statement contained in an application or request for an authorisation under the Clinical Trials Regulations..

(3) After paragraph (2)(g) insert the following sub-paragraph—

(h)information and documents relating to clinical trials.

(4) In paragraph (3)—

(a)omit “or” following sub-paragraph (a); and

(b)following paragraph (b) insert “ ; or ” and the following sub-paragraph—

(c)a medicinal product used, or intended to be used, in a clinical trial.

(5) In paragraph (4)—

(a)after “require” insert “ — (a) ”; and

(b)after “control” insert “ ; or ” and the following sub-paragraph—

(b)a person associated with a clinical trial to produce information or documents relating to the clinical trial which are in the person's possession or under the person's control.

(6) In paragraph (5)(a) for “(2)(f) or (g)” substitute “ (2)(f), (g) or (h) ”.

(7) After paragraph (9) insert the following paragraph—

(10) In this regulation, “a person associated with a clinical trial means any of the following—

(a)the sponsor of a clinical trial (within the meaning of regulation 3 of the Clinical Trials Regulations);

(b)any person who, under arrangements made with the sponsor of a clinical trial, carries out functions of the sponsor of the trial;

(c)in investigator for a clinical trial (within the meaning of regulation 2(1) of the Clinical Trials Regulations);

(d)any person, other than an investigator, who conducts a clinical trial;

(e)any person occupying premises at which a clinical trial is being conducted; or

(f)any person who, in the course of employment with a person listed in any of sub-paragraphs (a) to (e), undertakes activities in connection with a clinical trial..

(8) In regulation 335(6) (contravention due to fault of another person) omit “and” after sub-paragraph (e) and after sub-paragraph (f) insert “ ; and ” and the following sub-paragraph—

(g)any obligation or prohibition under the Clinical Trials Regulations.

(9) In regulation 336(3) (warranty as defence) omit “and” after sub-paragraph (c) and after sub-paragraph (d) insert “ ; and ” and the following sub-paragraph—

(e)regulation 46 of the Clinical Trials Regulations (labelling).

Back to top

Options/Help

Print Options

You have chosen to open The Whole Instrument

The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open The Whole Instrument as a PDF

The Whole Instrument you have selected contains over 200 provisions and might take some time to download.

Would you like to continue?

You have chosen to open the Whole Instrument

The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open the Whole Instrument without Schedules

The Whole Instrument without Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open Schedules only

The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

Close

See additional information alongside the content

Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.

Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

Explanatory Memorandum

Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Impact Assessments

Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:

  • Why the government is proposing to intervene;
  • The main options the government is considering, and which one is preferred;
  • How and to what extent new policies may impact on them; and,
  • The estimated costs and benefits of proposed measures.
Close

Timeline of Changes

This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.

Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as made version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources