Published on Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (https://archiwum.urpl.gov.pl)

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NATIONAL PROCEDURE

Submitted by admin on Mon, 19/02/2018 - 10:45

If at least one active substance of the biocidal product is still in the review program
in relevant PT and is not approved yet, then the biocidal product should be authorised in Poland according to the national procedure (during the transitional period). The fees for the registration under the national procedure are presented in the table below.

Application Type

Total fee [PLN]

application for authorisation for placing of a biocidal product on the market

1 000

application for  data modification of  the authorisation

500

application for  change of the authorisation holder

100

 


Source URL: https://archiwum.urpl.gov.pl/en/national-procedure