Search Legislation

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

 Help about what version

What Version

 Help about opening options

Opening Options

Status:

This is the original version (as it was originally made).

Insertion of regulation 43A (approved country for import)

This section has no associated Explanatory Memorandum

19.  After regulation 43 insert—

Approved country for import

43A.(1) The licensing authority must publish a list of countries which it is satisfied have a regulatory framework applicable to investigational medicinal products exported to the United Kingdom that is equivalent to the regulatory framework in the United Kingdom, in that the respective control and enforcement activities in those countries ensure an equivalent level of protection of public health.

(2) In order to determine whether a country should be included in the list referred to in paragraph (1), the licensing authority may, in particular, take into account—

(a)the country’s system for ensuring that each batch of an investigational medicinal product has been manufactured and checked in accordance with the requirements of its legislation and any authorisation in respect of the clinical trial in which the product is to be used;

(b)the country’s rules for good manufacturing practice;

(c)the regularity of inspections to verify compliance with good manufacturing practice;

(d)the effectiveness of enforcement of good manufacturing practice;

(e)the regularity and rapidity of information provided by that country relating to non-compliant manufacturers of investigational medicinal products;

(f)any on-site review of that country’s regulatory system undertaken by the licensing authority;

(g)any on-site inspection of a manufacturing site in that country observed by the licensing authority; and

(h)any other relevant documentation available to the licensing authority.

(3) The licensing authority must—

(a)review the countries it has included in the list referred to in paragraph (1) to determine if it is still satisfied that the country should remain on that list, and if it is not so satisfied, remove that country from the list; and

(b)undertake such a review at least every three years beginning with the date on which that country is included in that list..

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