Homeopathic medicines can access the following procedures to obtain a marketing authorization:
1. Simplified registration procedure
Access to this procedure is allowed only if the medicine meets the following requirements (Article 16) of Legislative Decree 219/2006:
a) it is intended to be administered orally or externally;
b) it does not bear specific therapeutic indications on the label or within information of any kind referring to the product;
c) it has a degree of dilution such as to guarantee safety; in any case the medicinal product cannot contain more than one part per ten thousand of mother tincture, nor more than 1/100 of the smallest dose possibly used in allopathy for active substances whose presence in an allopathic medicinal product entails the obligation of a medical prescription.
Law no. 190/2014 extended the possibility of accessing the simplified procedure also to medicines used for administration routes other than oral/external and in weight concentration (i.e. the substances used are analytically detectable).
2. Procedure for renewal of the ope legis authorization (Law no. 190/2014)
This procedure applies only to products already on the market under the transitional provisions, in the absence of therapeutic indications.
For these products the possibility was provided of:
- submitting the dossiers according to the requirements defined by AIFA (AIFA determination no. 365 of 31 March 2015);
- paying an ad hoc fee applicable only to these products and for the terms identified by the legislation;
- simplifying the documentation relating to Module 4 of the dossier (part of the registration dossier relating to the preclinical documentation, necessary to document the safety of the product), or the possibility of presenting, as an alternative to Module 4, a self-certified declaration signed by the legal representative of the owner company, bearing evidence of the safety of the product, having regard to its composition, pharmaceutical form and route of administration; consumer sales data for the last 5 years, and any Pharmacovigilance reports pursuant to the provisions of Title IX of Legislative Decree 219/2006.
The possibility was not granted of self-certifying the safety documentation for homeopathic medicines of biological origin, preparations for injectable use and preparations with weight concentrations of the homeopathic strain, in fact the obligation to submit Form 4 is confirmed.
In any case, the application of Pharmacovigilance is provided for homeopathic medicines which do not meet all the requirements of Art. 16, paragraph 1 of the Legislative Decree 219/2006.
AIFA has already issued numerous MAs for homeopathic medicines on the basis of this procedure. The authorized products are present in the Agency's Medicine Database.
For all dossiers under evaluation according to the procedures described above, AIFA establishes whether to issue specific warnings or restrictions on use for population groups.
In any case, since these are medicines with no therapeutic indications, it is recommended to consult your doctor or pharmacist before administration, when used in pregnancy and breastfeeding or in the paediatric age.
3. Ordinary authorization procedure (Art. 18, paragraph 1, first sentence, Legislative Decree 219/2006)
Homeopathic medicines which do not meet the requirements listed in Article 16 of Legislative Decree 219/2006, undergo a procedure similar to the one provided for allopathic medicines (Articles 8, 10, 11, 12, 13 and 14 of Legislative Decree no. 219/2006), which provides for the presentation of documentation relating to quality, safety and efficacy.
In this case, the authorization dossier must contain clinical studies supporting the therapeutic indications requested. Therefore, the homeopathic medicinal product authorized with this procedure will have therapeutic indications.
Currently, no medicine authorized by AIFA falls under this type of procedure.
4. Authorization procedure on the basis of homeopathic medicine practiced in Italy (Art. 18, paragraph 1, second sentence, Legislative Decree no. 219/2006)
Homeopathic medicines which do not meet the requirements listed in Article 16 of Legislative Decree 219/2006, may take advantage of an authorization procedure based on the homeopathic tradition recognized and practiced in Italy. In this case, specific rules for preclinical and clinical tests may be provided (by decree of the Ministry of Health after consulting AIFA), in line with the principles and characteristics of homeopathic medicine practiced in Italy.
At present this procedure has not been activated.