Safety Features Newsletter - 30 November 2017

November 2017

 

 Implementation Advisory Board meeting moved to January

 

Unfortunately, due to circumstances outside of our control, the Implementation Advisory Board has been postponed until January 2018.

 

We will continue to progress work with stakeholders here in the UK as well as the work we are doing with colleagues at a European level to ensure consistency and to address implementation challenges.  We recognise the importance of clarity and certainty over the UK’s approach to implementation and will be continuing to work collaboratively with stakeholders to identify issues and develop solutions together.

 

European Commission Q&A

 

Version 8 of the European Commission Q&A on safety features for medicinal products for human use has been published on their website. The link is here.

 

 

Secondary Care FAQ

 

NHS Improvement and Specialist Pharmacy Service colleagues have prepared an FAQ document to help raise awareness and understanding across secondary care. The link is here.

 

SecurMed UK Update

 

SecurMed UK has published an outline implementation plan giving target milestones for the UK Medicines Verification System.  We understand in early Q1 2018, SecurMed UK will publish UK Funding Model, setting out the fee structure and contracting model for Marketing Authorisation Holders. SecurMed UK request all manufacturers and parallel distributors pre-register with SecurMed UK.   Please refer to the SecurMed UK website at www.securmed.org.uk for more details.

 

For further information on SecurMed, the FMD implementation and how to register for the IT System Solution Provider toolkit please visit www.securmed.org.uk For questions to SecurMed please email info@securmed.org.uk

 

Questions relating to FMD process or compliance should be addressed to FMD.safetyfeatures@mhra.gov.uk

 

Wholesaler guidance

 

We have been asked by wholesaler dealers when they might need to verify stock which is received into their warehouse.  A document has been prepared which addresses a number of different scenarios and which you may find helpful.  We are looking to host this on our website, however in the meantime if you do not find the answer to your question here please contact us via the mailbox.

 

Mailbox

 

MHRA will continue to answer your questions about FMD through our dedicated mailbox, FMD.safetyfeatures@mhra.gov.uk Please send queries to this mailbox rather than other MHRA email addresses.

 

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).

 

 

Best regards,

MHRA Safety Features team

 

Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London SW1W 9SZ, UK

gov.uk/mhra

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