• Modus

PLPI Post (Aug-19)


The latest PLPI post is now out, dated August 2019.


Guidance updated on converting Parallel Distribution Notices into Parallel Import Licences in the event of a no-deal Brexit

Brexit is still very much an unknown at this time, so it’s impossible to gauge whether the UK will leave with a deal or no-deal, or even if the UK will leave at all on 31st October 2019 - as the leave date may be extended again. Nevertheless, it’s important to plan should the UK leave without a deal in October.

Do you have a comprehensive action plan in place to manage the conversion?


Variation Submissions

The MHRA are noticing a high number of ‘simple’ errors on submissions. It’s essential that care and attention is given to documents and imperative that good document control is used.

What systems do you have in place to control this?


Opioid Addiction Warning

The warning on opioid-containing medicines should be on packs by 15th September 2019.

Are you ready or do you need help with submitting the variations?


Additional information has been given on the FMD (Falsified Medicines Directive) and identifying UK PL Holders.


If you need any further information or help with any of the above topics, please give us a call or email:


Telephone:

+44(0)1233 770 630 (Office)

+44(0)7894 712 912 (Lorna)

+44(0)7403 756 965 (Tom)


​Email:

info@modus-cl.co.uk

lorna@modus-cl.co.uk

thomas@modus-cl.co.uk






#regulatory #plpi #plpipost #mhra #brexit #fmd #variations

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