Application for authorisation to conduct toxicological and pharmacological trials (non-clinical trials)

Here you can find guidelines and application forms for authorisation to conduct toxicological and pharmacological trials with a view to assessing the safety of medicinal products (non-clinical trials).

Please see Company authorisations and registrations for general guidance on applications for company authorisations, including the requirements and deadlines to be observed.

Guidelines

Requirements and deadlines for applications for company authorisations

Guidelines on application for authorisation to conduct toxicological and pharmacological trials with a view to assessing the safety of medicinal products (non-clinical trials) (PDF file, opens in a new window)

Form

Application form for authorisation to conduct toxicological and pharmacological trials with a view to assessing the safety of medicinal products (non-clinical trials) (Word file, opens in a new window)