CATrialAuthorisation object
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)
Ethics committee(s)
Other
CA - Submission for authorisation mandatory for
MD CE-marked, use outside label
MD CE-marked, use outside label + IMP
MD without label
MD without label + IMP
CA - Submission required to
National CA
Additional Information
(1) If GMO involved:
Swedish Gene Technology Authorities (the Authorities responsible for the regulations of activities involving GMOs)
In addition to MPA approval, a notification or application for permit might be necessary to be submitted to the Swedish Work Environment Authority SWEA (LVFS 2004:10). The rules are specified in SWEA Provisions (AFS 2011:2) on contained use of genetically modified micro-organisms.
(2) If ionising radiation is used the following authority shall be additionally involved:
Swedish Radiation Safety Authority
