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Attention Parallel Importers! New PLPI Post


The new PLPI Post is now out, dated September 2019.


GTIN

Information and advice is given on reusing Global Trade Identification Numbers (GTIN). Due to patient safety and other issues, companies should not be reusing these - links to further information has been provided.


FMD – Italy and Greece

Further guidance has been issued on the checking of Italian and Greece stock with regards to FMD, as they have yet to implement the 2d barcode UI system. This is a ‘must read’, but if you’re still not clear or need further advice, please get in touch with us.


Emollients

There is a risk of severe or even fatal burns with emollients containing more than 50% paraffins. It’s been concluded that the benefits of these products outweigh the risks, however, the outer packaging and leaflets need to be updated to highlight the fire hazard risks. Variations must be submitted ASAP – if you need help with preparing these variations, give us a call.


Reminders

  • Leaflet variations – sections 5 and 6 should reflect currently granted information only.

  • Opioids – All warnings must be in place now, so any products that do not have these warnings must not be used. If you require assistance in submitting these variations, we can help.


Suppliers Declaration

Regardless of whether you’ve submitted a supplier declaration, the MHRA are requiring lists of suppliers to be submitted twice a year, with the first one due by the end of October 2019.

Not adequately checking your suppliers will result in you having to update and submit supplier lists as is currently being done for Company Functions lists – this means you will not be able to buy from a supplier until it’s approved!!

Supplier checks are vital – so if you’re having trouble with this, get in touch and we can help you.


More detailed information is given in the PLPI Post, but if you need help or advice with the above requirements or anything else Parallel Import - call us today.

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 #parallelimport #plpi #plpipost #fmd #supplierqualification #variations


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+44(0)7894 712912 
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