Post-implementation Review of the Human Medicines Regulations 2012 (MLX 391)
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.
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:
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the Pharmacovigilance Directive (Directive 2010/84/EU (amending Directive 2001/83/EC) (Section 1 of the questionnaire)
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cross Border Prescriptions (Section 2 of the questionnaire)
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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 respondTell 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.