What we do
Technical and regulatory support;
Notification of homeopathic products that don’t have therapeutic indications under a pharmaceutical presentation and dosage that don’t present risk to the patient;
MIA (Market Introduction Authorization) request for homeopathic products that have a therapeutic indication or are commercialized under a presentation that may cause any risk to the patient.
Homeopathic medicinal product is “any medicinal product prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may also contain a number of principles.Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001