CASubmissionFormat object

Standard application form available

Yes

Standard application form

A standard application form (in Polish) is provided in Annex 1 of the Order of the Minister of Health 2 May 2012 (Dz.U. 2012, item.491).
The template is also available for download on the CA website (in Polish) in section: Produkty lecznicze » Badania kliniczne » Formularze.

Guidance on submission format

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))

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