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

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