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Safety Features Newsletter – 4 (April 2017)

April 2017

UK General Election

While Government consultations cannot be published in a pre-election period, we will be seeking to publish the public consultation as soon as possible after the General Election on 8th June – we do understand that stakeholders need the UK’s approach to implementation finalised at the earliest opportunity.  In the meantime, we will continue to advance work where we can and will also be looking to see where time savings can be made to the government’s implementation timetable.

Once published, the UK public consultation will include our draft impact assessment of the costs and benefits of implementing safety features as well as the draft statutory instrument on the UK specific legal changes which will need to be made.  Alongside the public consultation we will also be publishing a guidance document to address practical issues of implementation.

SecurMed UK

SecurMed UK (the not for profit organisation which will deliver the UK Medicines Verification System) will be continuing to work on setting up the repositories IT system, which will enable the verification of prescription medicines.  If you have questions relating to the UK Medicines Verification System, please contact Jerome Bertin, General Manager of SecurMed UK – jerome.bertin@securmed.org.uk – or your industry association (ABPI, BGMA, BAEPD, HDA, CCA, NPA).

European Commission Q&A document

The Commission has prepared a “questions and answers” document to help facilitate implementation; this is updated on a regular basis following discussions with Member States and is available on their website via the link below:

https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/qa_safetyfeature_v5_0.pdf

Mailbox for FMD enquiries

All MHRA email addresses have been amended to remove the .gsi.  Please update your contact list accordingly:

The mailbox for FMD enquires will remain available and can provide factual information.  Please contact us at FMD.safetyfeatures@mhra.gov.uk

The mailbox is monitored daily and you can expect to receive a response within 5 working days.   If you don’t currently receive a copy of the newsletter and would like to, please email by return with the following – your name, your organisation (if applicable) and your title (if applicable).

Please note there will not be a May newsletter – the newsletter will resume in June.

Safety Features Newsletter – 4 (April 2017)
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