Pink Sheet is part of the Business Intelligence Division 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

Batch testing requirements lifted by U.S.-EU GMP agreement signed in late June.

This article was originally published in The Tan Sheet

Executive Summary

EUROPEAN BATCH TESTING REQUIREMENT TO BE DROPPED IN THREE YEARS under the final mutual recognition agreement on Good Manufacturing Practices signed by the U.S. and European Union June 20. Under the agreement, companies will not be required to conduct point-of-entry batch testing, "provided that these controls have been carried out in the U.S. and that each batch/lot is accompanied by a batch certificate...issued by the manufacturer certifying that the product complies with the requirements of the marketing authorization."
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS087282

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

Cancel