Search Legislation

Medicines and Medical Devices Act 2021

 Help about what version

What Version

 Help about advanced features

Advanced Features

Changes over time for: Paragraph 13

 Help about opening options

Alternative versions:

Status:

This version of this cross heading contains provisions that are prospective. Help about Status

Close

Status

The term provision is used to describe a definable element in a piece of legislation that has legislative effect – such as a Part, Chapter or section. A version of a provision is prospective either:

  1. where the provision (Part, Chapter or section) has never come into force or;
  2. where the text of the provision is subject to change, but no date has yet been appointed by the appropriate person or body for those changes to come into force.

Commencement Orders listed in the ‘Changes to Legislation’ box as not yet applied may bring this prospective version into force.

Changes to legislation:

There are currently no known outstanding effects for the Medicines and Medical Devices Act 2021, Paragraph 13. Help about Changes to Legislation

Close

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.

Prospective

This section has no associated Explanatory Notes

13(1)The Secretary of State must prepare and publish guidance as to—U.K.

(a)the sanctions that may be imposed on a person who commits an offence under section 28 [F1, regulation 60A of the Medical Devices Regulations 2002 or regulation 23 of the Medical Devices (Northern Ireland Protocol) Regulations 2021;]

(b)the action that the Secretary of State may take in relation to such a person;

(c)the circumstances in which the Secretary of State is likely to take any such action.

(2)The guidance must include guidance about the Secretary of State's use of the power to impose a monetary penalty, with information as to—

(a)the circumstances in which such a penalty may not be imposed;

(b)the amount of such a penalty;

(c)the matters likely to be taken into account by the Secretary of State in determining that amount (including, where relevant, any discounts for voluntary reporting of non-compliance);

(d)how liability for such a penalty may be discharged and the effect of discharge;

(e)rights to make representations and objections and rights of appeal in relation to such a penalty.

(3)The guidance must include guidance about the Secretary of State's use of the power to serve an enforcement costs recovery notice, with information as to—

(a)the circumstances in which such a notice may not be served;

(b)the amount that a person may be required to pay;

(c)the matters likely to be taken into account by the Secretary of State in determining that amount;

(d)how liability for the costs to which the notice relates may be discharged and the effect of discharge;

(e)rights to make representations and objections and rights of appeal in relation to those costs.

(4)The guidance must include guidance about the Secretary of State's use of the power to accept an enforcement undertaking.

(5)Where appropriate, the Secretary of State must revise guidance published under this paragraph and publish the revised guidance.

(6)Before publishing guidance or revised guidance under this paragraph, the Secretary of State must consult—

(a)the Welsh Ministers, the Scottish Ministers and the Department of Health in Northern Ireland, and

(b)any other persons the Secretary of State considers appropriate.

(7)The Secretary of State must have regard to the guidance or revised guidance published under this paragraph in exercising functions under this Schedule.

Back to top

Options/Help

Print Options

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 Notes

Text created by the government department responsible for the subject matter of the Act to explain what the Act sets out to achieve and to make the Act accessible to readers who are not legally qualified. Explanatory Notes were introduced in 1999 and accompany all Public Acts except Appropriation, Consolidated Fund, Finance and Consolidation Acts.

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

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 enacted 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