Review of EU medicines legislation (''2001 Review'')

Background
In October 2001, the Commission published its proposals to amend the body of legislation covering the EU medicines regulatory regime (Regulation 2309/93 and Directives 2001/82/EC and 2001/83/EC). Regulation 2309/93 established a centralised authorisation procedure for human and veterinary medicinal products and established the European Medicines Agency  (EMEA). Directives 2001/82/EC and Directive 2001/83/EC set out the Community codes for medicinal products for veterinary and human use. The Directives lay down provisions governing the marketing authorisation, manufacture and distribution of such products. Following detailed negotiations between the Council of the European Union and the European Parliament, agreement on the proposed legislative amendments was reached in early 2004.

The agreed texts were adopted by the Council and the European Parliament on 31 March 2004 as:

• Regulation (EC) No. 726/2004 (replacing Regulation 2309/93).
• Directive 2004/27/EC (amending Directive 2001/83/EC on human medicines).
• Directive 2004/28/EC (amending Directive 2001/82/EC on veterinary medicines).

The following Regulation was adopted on 14 June 2007 and complements Regulation 726/2004 by providing an EU penalties regime in respect of failures to comply with various aspects of the regulation:

• Regulation (EC) No. 658/2007

Links to copies of these Regulations and Directives are available under 'Related information (other sites)' at the right of this page.

Implementation of the new EU legislation
Regulation 726/2004 is directly applicable in national law and its main provisions have applied in the UK from 20 November 2005. The provisions of Directive 2004 had to be transposed into national law by 30 October 2005. The four Statutory Instruments listed below were made and laid before Parliament using the negative procedure, in order to implement the provisions of Directive 2004/27/EC.  They came into force on 30 October 2005. 

› The Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005 (SI 2005/2753) (100Kb)
› The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (SI 2005/2759) (102Kb)
› The Medicines (Advertising Amendments) Regulations 2005 (SI 2005/2787) (63Kb)
› The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005/2789) (164Kb)

SI 2005/2789 also revises the existing provisions of UK legislation which implement the provisions of Directive 2001/83/EC and Commission Directive 2003/94/EC relating to the manufacture and wholesale distribution of medicinal products. The instruments also introduce or amend a number of offences related to the Directive, and make amendments to various enactments as a consequence of the coming into force on 20 November 2005 of the remaining Titles of Regulation (EC) No. 726/2004, which establishes the European Medicines Agency (Title IV came into force on 1 May 2004).

MHRA documents and guidance
We have issued the following documents and guidance on the EU review of medicines legislation:

› MLX 309: Implementation of revised EU medicines legislation - published 29 July 2004
› MLX 317: Consultation on the Review of EU Medicines Legislation (the '2001 Review') - published 22 March 2005

User testing of patient information leaflets - published 27 June 2005
We issued the following  documents on the implementation of the new medicines legislation in relation to patient information:
› Guidance on the user testing of patient information leaflets (33Kb)
› Questions and answers to support the MHRA guidance on user testing of patient information leaflets (37Kb)
› New provisions concerning Braille on labels and in the patient information leaflet of all medicines - published 21 October 2005
› New medicines legislation: guidance on national marketing authorisation renewal applications - published 27 October 2005

EMEA documents and guidance
Guidance documents produced by the EMEA in relation to Regulation (EC) No. 726/2004 are available on their website:

› EMEA Implementation of the New EU Pharmaceutical Legislation (external link)

Public Assessment Reports

Articles 21(3) and 21(4) – transparency and Public Assessment Reports (Article 1(19) of Directive 2004/27/EC)
A new provision in Directive 2004/27/EC obliges competent authorities to make publicly available without delay the marketing authorisation, Summary of Product Characteristics, and assessment report, and reasons for the opinion after deletion of commercially confidential information. 

The MHRA uses website publication in order to fulfil these obligations. The working definition of commercially confidential information (for deletion) closely follows that used by the EMEA for products authorised in the Centralised Procedure and is consistent with the exemptions set out in the Freedom of Information Act. Applicants are given the opportunity for pre-publication comment. This provision applies to new products and significant variation applications submitted after 30 October 2005.
› Public Assessment Reports