Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Updated EU Guide On Unique Identifiers May Impact Drug Distribution Strategies Post Brexit

Executive Summary

The European Commission's updated guidance on the unique identifiers that are required under the Falsified Medicines Directive contains new information on several areas. It clarifies that the “decommissioned status” of an exported medicine that is brought back into the EU from a third country cannot be reversed and that such medicines should be fitted with a fresh identifier.

You may also be interested in...



Updated EU Guide On Safety Features Addresses Parallel Trade Repackaging

The EU guideline on complying with the requirement to affix safety features on medicine packs has been updated to address specific aspects of parallel trade, such as re-sealing of medicine packs that are legally opened to replace patient information leaflets.

EU’s Medicines Authentication System Hits Implementation Problems At National Level

The EU’s new medicines verification system, which is due to come into operation in February 2019, is experiencing delays, partly as a result of differences in member state approaches to the implementation of safety features on product packs. The European association representing generic and biosimilar firms has warned that any delays in setting up the system could lead to product shortages.

COVID-19 Vaccine Dosing: Pharma Says Follow The Science As It Gathers Data

The UK’s deployment of COVID-19 vaccines has left vaccine manufacturers worried about emerging discussions on dosing strategies that may not be supported by authorized labeling or published clinical data.

Topics

UsernamePublicRestriction

Register

OM006051

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel