ECSubmissionOfApplication object
Responsible for study submission
Sponsor
Investigator
Guidance on study submission
The application process is described in detail in a regulation issued by the Minister of Health (Order of the Minister of Health 2 May 2012 (Dz.U. 2012 poz.491).
The supporting documentation of application is specified in Art 37m of the Act on Pharmaceutical Law of 6 September 2001 (en).
Applicable national legal framework/ Reference
37r-37x of the Pharmaceutical Law 2001 (en)/ Dz.U. 2008 nr 45 poz. 271 (pl)
Order of the Minister of Health 2 May 2012 (Dz.U. 2012 poz.491)
