HOMEOPATHIC MEDICINAL PRODUCTS FOR HUMAN USE
A homeopathic medicinal product is any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the EU Member States.
All homeopathic medicinal products may also be placed on the market only after they have been granted marketing authorisation in the Republic of Slovenia.
OBTAINING MARKETING AUTHORISATION
In Slovenia, a homeopathic medicinal product may obtain marketing authorisation:
– under the regular procedure (in accordance with Article 44 of the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/2014; hereinafter: ZZdr-2), if the medicinal product is presented as providing healing effects for specific therapeutic indications;
– under a special, simplified procedure in accordance with the Rules on homeopathic medicinal products for human use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 94/2008), if the homeopathic medicinal product satisfies the following conditions:
- it is administered orally or externally;
- no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto;
- there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product may not contain more than 1 part per 10,000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor’s prescription, unless the European Commission decides otherwise on the basis of new scientific evidence.
A homeopathic medicinal product marketing authorisation may be obtained under the national procedure, mutual recognition procedure or decentralised procedure in accordance with the ZZdr-2 and the Rules on marketing authorisation of medicinal products for human use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 57/2014).
An application for marketing authorisation under the simplified procedure may refer to several degree of dilution and pharmaceutical forms that are prepared from the same homeopathic stock. It must contain:
- a cover letter from the applicant;
- the application form for a homeopathic medicinal product (Form);
- one or more specimens or a mock-up of the outer and immediate packaging of the medicinal product to be registered, in Slovenian language;
- the documentation for obtaining marketing authorisation for a homeopathic medicinal product.
The documentation must include pharmaceutical, chemical, biological, microbiological and pharmaco-toxicological data and documents on the homeopathic medicinal product in accordance with Annex I to Directive 2001/83/EC. The applicant should submit the information and documents in the form of the common technical document (CTD) – modules 1-4 and module 5 (justification of homeopathic use) in accordance with the detailed instructions of the Homeopathic Medicinal Products Working Group (HMPWG), which operates within the framework of the Heads of Medicines Agencies (HMA) (website: http://www.hma.eu/hmpwg.html).
Fees relating to the issuance, variation, renewal, transfer and termination of marketing authorisation for a homeopathic medicinal product are specified in Article 28 of the Rules relating to fees in the area of medicinal products (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 9/2018).
It should be noted that in Slovenia there are no specific rules for pre-clinical and clinical trials of homeopathic medicinal products that differ from the rules for testing allopathic medicine (obtaining marketing authorisation for a homeopathic medicinal product in accordance with Article 16 of Directive 2001/83/EC is not possible).
Other important particularities of homeopathic medicinal products
Each homeopathic medicinal product placed on the market should include, in addition to the label “Homeopathic medicinal product”, information in Slovenian on the immediate and outer packaging, as required by Article 17 of the Rules on homeopathic medicinal products for human use.
It is forbidden to advertise homeopathic medicinal products that have obtained marketing authorisation under the simplified procedure by claiming that they have healing properties or therapeutic indications or any information relating thereto.