CASubmissionOfApplication object
Responsible for study submission
Sponsor
Entitled to study submission
Sponsor
Investigator
Guidance on submission of application
The documentation of application is specified in Art 37m of the Act on Pharmaceutical Law of 6 September 2001
The application process is described in detail in a regulation issued by the Minister of Health (The Order of the Minister of Health 2 May 2012 (The Official Journal, Dz.U. 2012, item.491))
Applicable national legal framework/ Reference
Art 37m of the Act on Pharmaceutical Law of 6 September 2001