The Act on Pharmaceuticals does not stipulate any special form of application. An application lodged in compliance with Section 34, paragraph 3 of the Act on Pharmaceuticals must therefore meet the requirements of the Administrative Code. These are provided in Section 45, in compliance with Section 37, paragraph 2 of the Administrative Code.
Requirements governing an application pursuant to Section 37, paragraph 2 of Act No 500/2004 Coll., the Administrative Code, as amended, are attached in the annex - Requirements governing applications pursuant to Section 37.pdf, (612.46 kB).
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