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

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