Guideline on the excipients warnings to be included in the printed of homeopathic medicines (12/12/2
Guideline on the excipients warnings to be included in the printed (label and package leaflet) of homeopathic medicines.
The elaboration of the guide line is intended to ensure a correct information for the user.
It is the guideline to be used for the inclusion of warnings in the printed (label and package leaflet) of homeopathic medicinal products applies:
the applications for renewal of the marketing authorization of homeopathic medicines in art. 20 of Legislative l.gs. n. 219/2006;
the simplified registration of art. 16 of D.l.gs. n. 219/2006 (art. 14 of Directive 2001/83 / EC) and of homeopathic medicines approval procedures in art. 18 of the same decree, if applicable;
instances of variation for homeopathic medicinal products marketed under the transitional provisions of art. 20, paragraph 1, of D.l.gs. n. 219/2006, with impact on the printouts, where, for security reasons, must be included warnings about excipients.
Attached:
Communication of Guideline
Guideline on the excipients warnings to be included in the printed (label and package leaflet) of omeopa medicines
