Assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products - Scientific guideline

Guidance on the scientific data/information, parameters, test conditions and default values that should be used for the assessment of persistent, bioaccumulative and toxic or very persistent and very bioaccumulative veterinary medicinal products.

Keywords: PBT criteria, environmental risk assessment, PBT emission, PBT risk management, veterinary medicinal product (VMP)

Current effective version

Guideline on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products

AdoptedReference Number: EMA/CVMP/ERA/52740/2012

Document history

Question and answer document in support of the guideline on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012)

Reference Number: EMA/593989/2019

Guideline on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products

AdoptedReference Number: EMA/CVMP/ERA/52740/2012

Overview of comments received during the second public consultation on 'Guidance on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinar...

Reference Number: EMA/CVMP/ERA/74265/2015

Overview of comments received during the first public consultation on 'Guidance on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary...

Reference Number: EMA/CVMP/ERA/102239/2013Summary:

Overview of comments received during the first round of the public consultation.

Draft guidance on the assessment of persistent, bioaccumulative and toxic or very persistent and very bioaccumulative substances in veterinary medicine

Draft: consultation closedConsultation dates: 27/10/2014 to 27/01/2015Reference Number: EMA/CVMP/ERA/52740/2012Summary:

Persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) are combinations of substance properties which give substances the potential to accumulate in remote environments which is difficult to reverse as cessation of emission will not immediately result in a reduction in chemical concentration due to long half-life. The aim of this guideline is to clarify an assessment strategy for identification of potential PBT veterinary medicines on the basis of the data available within a dossier.

Concept paper on assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicine

Draft: consultation closedConsultation dates: 15/07/2010 to 01/09/2010Reference Number: EMA/CVMP/ERAWP/389867/2010