Medicines regulatory news
On 1 July 2011 the European Commission published the Falsified Medicines Directive (FMD) 2011/62/EU (external link) in the Official Journal of the European Union. The FMD amends Directive 2001/83/EC in a number of places, and amongst others, places new obligations on:
- manufacturers, distributors and brokers of medicinal products
- manufacturers, importers and distributors of active substances.
The first of the changes introduced by the FMD will need to be in force in UK legislation from 2 January 2013. Before the formal public consultation on proposals to implement the FMD, the MHRA is seeking information from industry to inform an initial economic Impact Assessment.
This Impact Assessment needs to outline anticipated costs to the UK’s pharmaceutical industry in meeting the regulatory obligations placed by on it by the FMD, where those costs are a change to an established practice. Such practice may be a result of current legislation or guidance.
Below you will find a document describing the background to changes introduced by the FMD. This document also contains a series of questions for different industry sectors. We recommend that you familiarise yourself with the content of the background document, and use this as a base to collate the information requested.
Once you have assembled the information, you can submit the information to us electronically using Surveymonkey (external link).
All information submitted will be treated in confidence.
We would appreciate it if responses to the questionnaire could be submitted before close of business on Friday 3 February 2012.
We will continue to accept information submitted after this date, although we cannot guarantee that it will be used in the preparation of the initial Impact Assessment.
If you have any further questions about the questionnaire or survey, please contact:
Alan Bentley (Regulatory Advice Unit, I,E&S Division)
Tel: 020 3080 6813
Email: alan.bentley@mhra.gsi.gov.uk
Pre-consultation Industry Questionnaire 
