This Draft Resolution provides for registration, renewal of registration, post-registration changes and notification of industrialized dynamized drugs.

The technical regulation that establishes the minimum requirements for registration, renewal of registration, post-registration changes and notification of industrialized dynamized drugs, in accordance with this Resolution, is hereby approved.

This resolution applies to industrialized dynamized drugs. Homeopathic, anthroposophic and antihomotoxic medicines are considered as dynamized drugs, framed in specific categories according to the criteria set forth in art. 5 of this Resolution.

For the purpose of framing the different categories of dynamized drugs, the following classification should be observed:

I - are classified as homeopathic dynamized medicinal products those whose claim to use is defined based on the fundamentals of Homeopathy and that are elaborated according to homeopathic pharmacotechnical.

II - are classified as anthroposophic dynamized drugs those prepared according to anthroposophic pharmacotechnics or those whose claim and use is defined based on the foundations of Anthroposophic Medicine, even if prepared according to homeopathic pharmacotechnics.

III - anti-homotoxic drugs are defined as those that have their therapeutic indications defined according to the concepts of Homotoxicology and are elaborated in accordance with the homoeopathic or antihomotoxic pharmacotechnics.

The addition of colorings, sweeteners, flavorings and essences to the formulation of energized medicinal products shall not be permitted.

The claim of use of compounded dynamized medicinal products may be given considering the individual indication of each of the components of the drug and the rationale of the association must be proven.

This notification also establishes provisions regarding the restriction on the sale of industrialized dynamized drugs; notification of medicinal products; drug registration; registration and notification; renewal of registration; labelling; medication package; post-registration changes; and final and transitional provisions.

This resolution revokes the RDC nº 26, of 30 March 2007.