Consultation outcome

Post-implementation Review of the Human Medicines Regulations 2012 (MLX 391)

From:
Medicines and Healthcare products Regulatory Agency
Published
15 June 2017
Last updated
5 December 2017 — See all updates
This consultation has concluded

Download the full outcome

Post-implementation Review (PIR) - final report

PDF, 1.77 MB, 99 pages

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Detail of outcome

The main conclusion of the review was that on balance the 2012 Regulations represent a sound consolidation of fragmented and complex medicines legislation in one place, and in a simplified form to improve the coherence of the regulatory framework. The report contains four recommendations for some areas where further work is required.

Original consultation

Summary

We are reviewing the impact of the Human Medicines Regulations 2012 (‘the 2012 Regulations’). This is part of a wider exercise within government to test the impact of legislation five years after implementation.

This consultation ran from
to

Consultation description

We want to know what you think

We would appreciate your help in understanding the impact of the 2012 Regulations. In particular, the aspects of the 2012 Regulations that, in our view, introduced the most significant changes.

These include:

  • the Pharmacovigilance Directive (Directive 2010/84/EU (amending Directive 2001/83/EC) (Section 1 of the questionnaire)

  • cross Border Prescriptions (Section 2 of the questionnaire)

  • the repeal of Section 10(7) of the Medicines Act 1968 on Pharmacy wholesale dealing (Section 3 of the questionnaire)

Please answer those sections of the questionnaire on the above changes that are relevant to you. In addition, we encourage all respondents to answer the general questions on the 2012 Regulations in Section 4 of the questionnaire.

Ways to respond

Tell us your views using the on-line version of the questionnaire.

Alternatively, please tell us your views by completing the MS Word version of the questionnaire (see Annex B in the documents section above). Information on where to submit your completed questionnaire is shown at the bottom of the questionnaire.

This consultation closes at 23:45 on Thursday 6 July 2017.

Documents

Annex A: Post-implementation Review (PIR) - consultation

PDF, 453 KB, 10 pages

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Annex B: Post-implementation Review (PIR) - consultation questions

MS Word Document, 361 KB

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Annex C: Post-implementation Review (PIR) - scope

PDF, 103 KB, 3 pages

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Published 15 June 2017
Last updated 5 December 2017 + show all updates

  1. Detail of outcome and attached report.

  2. First published.