- Latest available (Revised)
- Original (As made)
There are currently no known outstanding effects for the The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009.
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.
Statutory Instruments
Medicines
Made
6th May 2009
Laid before Parliament
7th May 2009
Coming into force
8th May 2009
Marginal Citations
M11972 c.68; section 2(2) was amended by the Legislative and Regulatory Reform Act 2006 (c.51), section 27(1)(a).
F11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regs. 1, 2 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)
F12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regs. 1, 2 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)
3. For paragraph 2 of regulation 30 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (urgent safety measures) M3, substitute the following paragraphs—
“(2) If measures are taken pursuant to paragraph (1), the sponsor shall—
(a)where paragraph (3) applies, as soon as possible; and
(b)in any other case, immediately, and in any event no later than 3 days from the date the measures are taken,
give written notice to the licensing authority and the relevant ethics committee of the measures taken and the circumstances giving rise to those measures.
(3) This paragraph applies for any period during which a disease—
(a)is pandemic; and
(b)is a serious risk to human health or potentially a serious risk to human health.”.
Marginal Citations
F24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
Signed by authority of the Secretary of State for Health.
Dawn Primarolo
Minister of State,
Department of Health
(This note is not part of the Regulations)
These Regulations make further amendments to the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994, the Medicines for Human Use (Clinical Trials) Regulations 2004 and the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 in connection with the transposition of Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (“the 2001 Directive”) and Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
Regulation 2 amends the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 to disapply the labelling requirements in Schedule 5 to those Regulations (which are supplementary to the requirements in Title V of the 2001 Directive) to antiviral medicines in solutions for children under one year of age whilst a disease which poses a serious risk, or potentially poses a serious risk, to human health is pandemic or imminently pandemic where the medicine is for the purpose of treating that disease. Instead of the disapplied requirements, the container of the medicine needs to be labelled to show only the name of the child to be treated, the date on which the medicine was dispensed and the necessary and usual instructions for proper use.
Regulation 3 amends the Medicines for Human Use (Clinical Trials) Regulations 2004 to allow for notice of urgent safety measures (taken in order to protect the subjects of a clinical trial against any immediate hazard to their health or safety and the circumstances giving rise to those measures) to be given as soon as possible to the licensing authority and an ethics committee established under Part 2 of those Regulations during a period in which a disease is pandemic and is a serious risk to human health or potentially a serious risk to human health.
Regulation 4 of these Regulations amends regulation 8 of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 to enable the wholesale distribution of unauthorised medicinal products in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation which could cause harm. It also incidentally corrects an erroneous reference in paragraph (3)(b) of that regulation to Article 5(2) of the 2001 Directive.
An Impact Assessment has been prepared in respect of these Regulations which is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.
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.
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: