Search Legislation

The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022

 Help about what version

What Version

  • Latest available (Revised)
  • Original (As made)
 Help about opening options

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This is the original version (as it was originally made).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.

Amendment of regulation 8

This section has no associated Explanatory Memorandum

4.  In regulation 8(1)(1) (general interpretation), at the appropriate places insert—

EAMS medicinal product” means a medicinal product that—

(a)

has been included in the Early Access to Medicines Scheme by means of the licensing authority issuing an EAMS scientific opinion in respect of it; and

(b)

remains in the scheme by virtue of the EAMS scientific opinion not ceasing to have effect in respect of it by virtue of regulation 167D;;

EAMS scientific opinion” is to be construed in accordance with regulation 167C(2)(b);;

EAMS scientific opinion holder” means the holder of a EAMS scientific opinion, and accordingly, is the person who places on the market the product to which the opinion relates;;

Early Access to Medicines Scheme” means the scheme of that name established and operated under regulation 167C(1);; and

EU Clinical Trials Regulation” means Regulation EU No. 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products, and repealing Directive 2001/20/EC(2);.

(2)

OJ L 158, 27.5.2014, p. 1.

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

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