UST-21 version 7

Reporting of Selected Medicinal Products and Batch Release onto the Market

This Guideline supersedes the previous version 6 of Guideline UST-21 as of 01 April 2021.

The Guideline is published on the basis of and in compliance with the provision of Section 102(1) of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended.

The Guideline is legally binding.

UST-21_version7_Reporting of Selected Medicinal Products and Batch Release onto the Market.pdf, file type pdf, (111.18 kB)

Annexes:

• Batch Release Request UST-21_version7_Annex1_Batch Release Request.docx, file type docx, (19,65 kB)
• Marketing Information Form (MIF) UST-21_version7_Annex2_Marketing information form.doc, file type doc, (37,5 kB)