All clinical investigations requiring authorisation by CA
Available in Polish: "Wzór wniosku o wydanie pozwolenia na wprowadzenie zmian w badaniu klinicznym"
By silent (implicit) approval
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 37 (x) of Pharmaceutical Law 2001/ Dz.U. 2008 nr 45 poz. 271 (pl)
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.