ECAmendment object
Any substantial amendments
Sponsor
Investigator
Yes
Available in Polish: "wzór wniosku o wydanie pozwolenia na wprowadzenie zmian w badaniu klinicznym"
35
Yes
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)).
This document includes a standard application form for the submission of amendments provided in Annex 2. This template is also available for download on the URPL website (pl) in section: Produkty lecznicze » Badania kliniczne » Formularze.
Art 37x Pharmaceutical Law 2001 (en)
Order of the Minister of Health 2 May 2012 (Dz.U. 2012 poz.491)
Amendments to be authorized: Any amendments to the clinical trial protocol or to the investigational medicinal product, being substantial and likely to have an impact on the safety of the clinical trial subjects.