Generics Bulletin 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


EU Commits To Flexibility On EPI

EU Regulators Adopt Key Principles On Electronic Product Information

Executive Summary

EU regulators have adopted key principles for using electronic product information for human medicines, which are now expected to be followed by all parties involved in developing and implementing ePI.

You may also be interested in...

Pharma Wary Of Over-Flexible EU Plan For Electronic Product Information

The pharmaceutical industry is concerned that too much flexibility may result in a “fragmented and cost intensive implementation” of the EU electronic product information framework.

EU Explores Key Principles For Using Electronic Leaflets, SmPCs

A multi-stakeholder workshop this month is expected to result in draft EU proposals on how to start disseminating product information in electronic formats.

PIC/S Supplements GMP Guidance On Cross Contamination In Shared Facilities

The international group of pharmaceutical inspectorates, PIC/S, has issued an aide-memoire and a Q&A document to support its 2018 guideline on using health-based exposure limits to assess the risk of cross contamination in shared manufacturing facilities.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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