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Biopharmaceutical products or products containing a PBT substance

Clarification about applications for biopharmaceutical products or products containing a persistent bio accumulative and toxic (PBT) substance to the environment


Work is currently being undertaken by the CVMP to provide greater clarity on the authorisation of products containing substances designated as persistent bio accumulative and toxic (PBT) to the environment.

The potential for PBT substances to have harmful effects on the environment will form part of the benefit:risk evaluation where the overall need for the product will be considered against potential risks.

The outcome of this evaluation has to be positive for a Marketing Authorisation (MA) to be granted. Therefore, it is important that the PBT aspects of a product are considered early in product development.

During product development, should you discover or have concerns, that a product you are developing contains a PBT substance, we advise you to come in for a company meeting before applying for a MA. Likewise for biopharmaceutical products, it would be helpful to meet with you prior to the submission of your application.

Biopharmaceuticals are outside the usual type of application and a meeting beforehand will help the VMD to better understand your product and assign the appropriate assessors.

To arrange a company meeting please contact Chris Abbott:

Published 15 April 2015