Homeopathic Medicinal Products
According to the §1 (3) of the XCV Medicines Act of 2005 homeopathic medicinal product is a medicine having been manufactured according to the Pharmacopoeia in compliance with the defined homeopathic manufacturing process, from homeopathic mother tincture; the product may contain more than one component.
Issuing the Manufacturing Authorisation of a Homeopathic Medicinal Product falls within the competence of the National Institute of Pharmacy.
The process of marketing auhtorisation and registering starts when the application is submitted to the National Institute of Pharmacy. Application may be made as follows:
1. The Homeopathic Medicinal Product may be authorised through a simplified procedure if the documentation is compiled according to the §9 (1) of Decree No. 52 of 18 November, 2005 of the Minister of Health.
The application has to be submitted in compliance with the Annex I. of Decree No. 52 of 18 November, 2005 of the Minister of Health – in CTD format (Module 1-4). This category refers to the Homeopathic Medicinal Products having been registered as „monocomponent” medicinal products and the ones having been registerd as „complex”medicinal products without therapeutic indication.
2. If the Marketing Authorisation Holder would like to have a therapeutic indication for the Homeopathic Medicinal Product according to the laws and regulations the procedure and fees have to be considered as it is done with the allopathic medicinal products – there is no difference between them.
The application has to be submitted in compliance with the Annex I. of Decree No. 52 of 18 November, 2005 of the Minister of Health – in CTD format (Module 1-5). This category refers to the Homeopathic Medicinal Products having been registered as „complex” medicinal products and have therapeutic indication in the Product Information documentation (Summary of Product Characteristics, Patient Information Leaflet, Labelling).
All criteria regarding the submitted documentation are the same as for Medicinal Products except for Notice to Applicants Volume 2B which should be downloaded for the Homeopathic preparations separately.