- Latest available (Revised)
- 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 39
Changes to legislation:
There are currently no known outstanding effects for the The Human Medicines Regulations 2012, Section 39.
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.
Further requirements for manufacturer's licenceU.K.
This section has no associated Explanatory Memorandum
39.—(1) This regulation applies in relation to any manufacturer's licence.
(2) The licence holder must maintain such staff, premises, equipment and facilities for the handling, control, storage and distribution of medicinal products under the licence as are appropriate in order to maintain the quality of the medicinal products.
(3) The licence holder must ensure that any arrangements made for the handling, control, storage and distribution of medicinal products are adequate to maintain the quality of the products.
(4) The licence holder must not handle, control, store or distribute medicinal products on any premises other than those specified in the licence as approved by the licensing authority for the purpose.
(5) The licence holder must inform the licensing authority before making a material alteration to the premises or facilities used under the licence, or to the purposes for which those premises or facilities are used.
(6) The licence holder must inform the licensing authority of any proposed change to—
(a)the qualified person; and
(b)any person named in the licence as having responsibility for quality control.
(7) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the licence, the licence holder must permit a person authorised in writing by the licensing authority to do anything that the licensing authority could have done for the purposes of verifying a statement made in an application for a licence.
[F1(8) In distributing a medicinal product by way of wholesale dealing, the licence holder must comply with the following as if they are a holder of a wholesale dealer’s licence—
(a)regulations 43(1), (2) and (5), 43ZA and 44(5) and (6), and
(b)regulation 43A, if applicable, where the product is being distributed in NI.]
Textual Amendments
F1Reg. 39(8) substituted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 9
Options/Help
Print Options
PrintThe Whole Instrument
PrintThe Whole Part
PrintThe Whole Chapter
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.
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.