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21. Is there an application for granting of exemption available on your website?

The Act on Pharmaceuticals does not set out any special form of application. The application submitted pursuant to Section 34a (3) of the Act on Pharmaceuticals shall comply with the requirements of the Act No. 500/2004 Coll., Administrative Code, which are listed in Section  45 pursuant to Section 37 (2) of the Act No. 500/2004 Coll., Administrative Code.

The application should list grounds explaining why the applicant assumes that there be a statutory reason for granting an exemption from the application of the sunset clause pursuant to Section 34a (3). These reasons should be documented by respective evidence, if appropriate.

The requirements for an application pursuant to Section 37 (2) of the Act No. 500/2004 Coll., Administrative Code, as amended, are enclosed in the Annex – application according to the Administrative Code, soubor typu pdf, (123.33 kB).