- Latest available (Revised)
- Point in Time (14/08/2012)
- Original (As made)
The Human Medicines Regulations 2012
You are here:
What Version
Advanced Features
- Show Geographical Extent(e.g. England, Wales, Scotland and Northern Ireland)
- Show Timeline of Changes
Changes over time for: Section 71
Version Superseded: 01/10/2014
Alternative versions:
- 14/08/2012- Amendment
- 14/08/2012
Point in time - 01/10/2014- Amendment
- 31/12/2020- Amendment
Status:
Point in time view as at 14/08/2012. This version of this provision has been superseded.
Status
You are viewing this legislation item as it stood at a particular point in time. A later version of this or provision, including subsequent changes and effects, supersedes this version.
Note 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.
Changes to legislation:
The Human Medicines Regulations 2012, Section 71 is up to date with all changes known to be in force on or before 26 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.
Changes to Legislation
Changes and effects yet to be applied by the editorial team are only applicable when viewing the latest version or prospective version of legislation. They are therefore not accessible when viewing legislation as at a specific point in time. To view the ‘Changes to Legislation’ information for this provision return to the latest version view using the options provided in the ‘What Version’ box above.
Withdrawal of medicinal product from the marketU.K.
This section has no associated Explanatory Memorandum
71.—(1) This regulation applies if—
(a)under regulation 68, regulation 70(2), Article 34(3) of the 2001 Directive or Regulation (EC) No 726/2004 the licensing authority or the European Commission revokes or suspends a marketing authorisation, or
(b)under regulation 69 or Article 20(4) of Regulation (EC) No 726/2004 the licensing authority suspends the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a marketing authorisation relates.
(2) The licensing authority may give written notice to the person who is, or immediately before its revocation was, the holder of the authorisation requiring that person to comply with both of the following requirements.
(3) Requirement A is to take all reasonably practicable steps to inform wholesalers, retailers, medical practitioners, patients and others who may be in possession of the product to which the authorisation relates of—
(a)the revocation or suspension;
(b)the reasons for the revocation or suspension; and
(c)any action to be taken to restrict or prevent further use, sale, supply or offer for sale or supply of the product.
(4) Requirement B is to take all reasonably practicable steps to withdraw from the market in the United Kingdom and recover possession of—
(a)the product; or
(b)the batches of the product specified in the notice,
within the time and for the period specified in the notice.
Options/Help
Print Options
PrintThe Whole Instrument
PrintThe Whole Part
PrintThe Whole Cross Heading
PrintThis Section only
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 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 The Whole Instrument without Schedules as a PDF
The Whole Instrument without Schedules 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?
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.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
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.
Opening Options
Different options to open legislation in order to view more content on screen at once
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.
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
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.
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.
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
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.