- Latest available (Revised)
- Point in Time (31/03/2014)
- Original (As made)
Version Superseded: 31/12/2020
Point in time view as at 31/03/2014.
The Human Medicines Regulations 2012, Paragraph 2 is up to date with all changes known to be in force on or before 18 August 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 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.
2.—(1) This paragraph applies to an application for a manufacturer's licence relating to the import from a state other than an EEA State of medicinal products.U.K.
(2) The application must contain—
(a)the name and address of the applicant;
(b)the name and address of the person (if any) making the application on the applicant's behalf;
(c)the name, pharmaceutical form, country of origin and marketing authorisation number of each imported medicinal product;
(d)the address of each set of premises where the importation operation is to take place;
(e)the address of each set of premises where any testing associated with the importation is to take place;
(f)the address of each set of premises where medicinal products are to be stored, or from which they are to be distributed;
(g)the name, address and qualifications of the qualified person; and
(h)the name, address, qualifications and experience of the person in charge of quality control.
(3) The application must also contain—
(a)details of the importation operations to which the licence is to relate;
(b)a statement of the facilities and equipment available at each set of premises where medicinal products are to be stored, or from which they are to be distributed;
(c)details of—
(i)any manufacturing of medicinal products carried on by the applicant on or near the premises mentioned in sub-paragraph (2)(d) to (f), and
(ii)the substances or articles manufactured or used in the manufacturing;
(d)a description of the arrangements for storage of the medicinal products after importation;
(e)a description of the arrangements at each set of premises for ensuring, so far as practicable, the turn-over of stocks of medicinal products;
(f)a description of the arrangements for maintaining—
(i)records of importation, and
(ii)records of analytical and other procedures applied in the course of importation; and
(g)a description of the arrangements for keeping reference samples of the medicinal products.
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?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
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?
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?
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?
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.
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.
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.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
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:
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.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: