April 23, 2010
Regulatory Deadline Approaching for CLP Compliance
The EU classification, labeling and packaging of substances and mixtures regulation (“EU CLP”) requires that:
Although the European Registration, Evaluation, Authorization of Chemicals (“REACH”) regulation exempts pharmaceutical substances from registration, evaluation and authorization, CLP will require a regulatory submission (notification) of all pharmaceutical substances being “placed on the market”.
Important Questions about the Applicability and Requirements of CLP and Pharmaceuticals
What does “placing on the market” really mean?
Which substances have to be notified to the Classification and Labeling (C&L) Inventory?
Will medicinal products need to be classified and notified to the C&L Inventory?
Note: There are currently NO exemptions from notification to the C&L inventory for quantity, research compounds, or active pharmaceutical ingredients. Although non-EU manufacturers are not subject to the requirement, it is reasonably certain that your European customers will be looking to you to help them with the notification, if not perform the notifications for them.
SafeBridge Can Provide:
The “SafeBridge Advantage” is that we understand the regulations as they apply to pharmaceuticals and related compounds, we have a staff of trained toxicologists and industrial hygienists and we have offices in both the US and Europe. For more information on these services, contact: Allan Ader, Ph.D., DABT at email@example.com or Todd Davidson, Ph.D., DABT at firstname.lastname@example.org.<< go back