Forms

Vigilance and surveillance of substances of human origin (tissues and cells)

  • Serious adverse reaction reporting form (annex 1, Rules on the vigilance and surveillance of substances of human origin (tissues and cells), Official gazette, No. 47/17),
  • Serious adverse event reporting form (annex 2, Rules on the vigilance and surveillance of substances of human origin (tissues and cells), Official gazette, No. 47/17),
  • Annual report form (annex 3, Rules on the vigilance and surveillance of substances of human origin (tissues and cells), Official gazette, No. 47/17). 

Licences in the field of competences

  • The prescribed form for obtaining a licence for performing the activity of supply of human tissues and cells for treatment does not exist.