2 Amendments of Daniël van der STOEP related to 2012/0192(COD)
Amendment 13 #
Proposal for a regulation
Recital 21
Recital 21
(21) It should be left to Member States to establish the language requirements for the application dossier. To ensure that the assessment of the application for authorisation of a clinical trial functions smoothly, Member States should consider accepting a commonly understood language in the medical fieldEnglish as the language for the documentation not destined to the subject.
Amendment 14 #
Proposal for a regulation
Recital 55
Recital 55
(55) In order to carry out the activities provided for in this Regulation, Member States should be allowed to levy fees. However, Member States should not require multiple payments to different bodies assessing, in a given Member State, an application for authorisation of a clinical trial.