KLH-21 version 7

Reporting Adverse Reactions to Medicinal Products for Human Use in a Clinical Trial and to Medicinal Products without Marketing Authorisation

KLH-21-version7.pdf, soubor typu pdf, (416.91 kB)

The guideline is being issued on the basis and in compliance with the provisions of Section 56, point 13) Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended (hereinafter referred to as the “Act on Pharmaceuticals“). The quideline is legally binding.

With effect from the date of issue (effective date 20th July 2018), this guideline supersedes guideline KLH-21, version 6.