Rules for formatting changes to the text of the labelling?

Medicinal products that are registered, re-registered:

In accordance with the Procedure for conducting expert evaluation of registration materials for medicinal products submitted for state registration (re-registration), as well as expert evaluation of materials on amendments to registration materials during the validity of the registration certificate (Order of the Ministry of Health of Ukraine 26.08.2005 No. 426 (as amended by the order of the Ministry of Health of Ukraine dated 04.01.2013 No. 3)

Annex 1

A title page to the amendments to the "Labelling to the registration certificate" is envisaged

Medicinal products that are registered, re-registered:

in accordance with the Procedure for conducting expert evaluation of registration materials for medicinal products submitted for state registration (re-registration), as well as expert evaluation of materials on amendments to registration materials during the validity of the registration certificate (Order of the Ministry of Health of Ukraine 26.08.2005 No. 426 (as amended by the order of the Ministry of Health of Ukraine dated 23.07.2015 No. 460)

Annex 2