Search Legislation

The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009

What Version

 Help about what version
  • Latest available (Revised)
  • Original (As made)

Opening Options

 Help about opening options

Status:

This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

Statutory Instruments

2009 No. 1164

Medicines

The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009

Made

6th May 2009

Laid before Parliament

7th May 2009

Coming into force

8th May 2009

The Secretary of State makes the following Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972(1). He is designated for the purposes of that section in relation to medicinal products(2).

Citation and commencement

1.  These Regulations may be cited as the Medicines for Human Use (Miscellaneous Amendments) Regulations 2009 and shall come into force on 8th May 2009.

Amendment of Schedule 5 to the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994

2.  After paragraph 8 of Schedule 5 to the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 (labels)(3) insert the following paragraph—

9.(1) In relation to a relevant medicinal product to which sub-paragraph (2) applies—

(a)paragraphs 1 to 7 do not apply; and

(b)the container of that product shall be labelled to show—

(i)the name of the person to whom the relevant medicinal product is to be administered,

(ii)the date on which the relevant medicinal product is dispensed, and

(iii)the necessary and usual instructions for proper use.

(2) This sub-paragraph applies to a relevant medicinal product which is—

(a)an antiviral medicine in the form of a solution which is to be used for the treatment of a child under the age of one year; and

(b)sold or supplied for the purpose of treating a disease which is—

(i)a serious risk to human health or potentially a serious risk to human health; and

(ii)which is pandemic or is imminently pandemic..

Amendment of regulation 30 of the Medicines for Human Use (Clinical Trials) Regulations 2004

3.  For paragraph 2 of regulation 30 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (urgent safety measures)(4), 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..

Amendment of regulation 8 of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

4.  For paragraph (3) of regulation 8 of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (requirement that holders of wholesale dealer’s licences comply with certain obligations)(5), substitute the following paragraph—

(3) The restriction in paragraph (2) shall not apply to—

(a)the sale or offer for sale of any exempt relevant medicinal product;

(b)the export to an EEA State, or supply for the purposes of such export, of a relevant medicinal product which may be placed on the market in that State without a marketing authorization by virtue of legislation adopted by that State under Article 5(1) of the Directive; and

(c)the sale, offer for sale or supply of an unauthorised medicinal product where the Secretary of State has temporarily authorised the distribution of that product under Article 5(2) of the Directive..

Signed by authority of the Secretary of State for Health.

Dawn Primarolo

Minister of State,

Department of Health

6th May 2009

EXPLANATORY NOTE

(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.

(1)

1972 c.68; section 2(2) was amended by the Legislative and Regulatory Reform Act 2006 (c.51), section 27(1)(a).

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

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

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.

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

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.
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 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