Homeopathic and anthroposophic preparations

(Articles 14 and 16 of Directive 2001/83/EC; Articles 17 and 19 of Directive 2001/82/EC)

Section 5 b of the Medicines Act defines a homeopathic preparation as a medicinal product that has been manufactured from homeopathic stocks using the homeopathic manufacturing procedure described in the European Pharmacopoeia. If the description is not in the European Pharmacopoeia, the official pharmacopoeia of a member state may be used. A homeopathic preparation may be manufactured from several homeopathic stocks. Provisions on homeopathic preparations also apply to other products that have been manufactured using homeopathic manufacturing procedures. Anthroposophic preparations are considered to be such products.

Further information can be found in the Finnish Medicines Agency administrative regulation 3/2015 ‘Application for marketing authorisation and registration of a pharmaceutical product and their renewal’: 3.8 Homeopathic and anthroposophic preparations

Products that may be registered in accordance with Article 14 of the human medicines directive 2001/83/EC or Article 17 of the veterinary medicines directive 2001/82/EC:

Art. 14: Only homeopathic medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure:

  • they are 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 either more than one 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.

Art. 17: Without restricting the application of the provisions of the Regulation (EEC) No 2377/90 on the establishment of maximum residue limits of pharmacologically active agents for production animals, only homeopathic veterinary medicinal products which satisfy all of the following conditions may be subject to authorisation by means of a special, simplified registration procedure:

  • they are administered by a route described in the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States,
  • no specific therapeutic indication appears on the labelling of the veterinary 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 one part per 10,000 of the mother tincture.

Products for which a marketingauthorisation application is required in accordance with Article 16 of the human medicines directive 2001/83/EC or Article 19 of the veterinary medicines directive 2001/82/EC:

Article 16:

Homeopathic medicinal products other than those referred to in Article 14(1) shall be authorised and labelled in accordance with Articles 8, 10, 10a, 10b, 10c and 11.

A Member State may introduce or retain in its territory specific rules for the toxicological and pharmacological tests and clinical trials of homeopathic medicinal products other than those referred to in Article 14(1) in accordance with the principles and characteristics of homeopathy as practised in that Member State. In this case, the Member State concerned shall notify the Commission of the specific rules in force.

Article 19:

Homeopathic veterinary medicinal products other than those referred to in Article 17(1) shall be authorised in accordance with the provisions of Articles 12, 13a, 13b, 13c, 13d and 14.

A Member State may introduce or retain in its territory specific rules for the pharmacological and toxicological tests and clinical trials of homeopathic veterinary medicinal products intended for pet animals and exotic species which are non food-producing other than those referred to in Article 17(1), in accordance with the principles and characteristics of homeopathy as practised in that Member State. In this case, the Member State concerned shall notify the Commission of the specific rules in force.

Requirements for documentation

Quality

According to the provisions, the quality and manufacture of each product must be detailed separately in all cases, as with other medicinal products.

Safety and efficacy

  • Products for which an indication is not suggested

Either the safety of the product must be demonstrated through original studies, or else it must be shown on the basis of published literature that the dilution concerned is safe in relation to the method of administration in question.

An expert statement on the safety of the product should be presented.

No specific demonstration of effect is required, but the homeopathic use of the product must be presented e.g. on the basis of the literature.

  • Provisions on pharmacovigilance must have been taken into account.

Products for which an indication for use is suggested

For safety, the same documentation as for products for which an indication is not suggested should be presented. Provisions on pharmacovigilance must also have been taken into account.

Efficacy must be proven as for other medicinal products.

If it is unclear whether the product to be placed on the market is a medicine or not, the Finnish Medicines Agency will, on request, classify the product. Information on the product should be submitted to the Pharmacovigilance Activities unit of the Finnish Medicines Agency for the decision on classification. The decision is subject to a fee. For more detailed instruction on the classification process, see ‘Classification and list of medicines’ on the Finnish Medicines Agency website.

Instructions on labelling and package leaflets, including specific instructions

Detailed instructions on the administrative regulations and normative guidelines relating to homeopathic and anthroposophic preparations can be found in the Finnish Medicines Agency administrative regulation 3/2013

The following matters should also be taken into account: An invented name may be used as the trade name of a combination product; the scientific name of the mother tincture is given as the active name and the degree of dilution as the strength; the marketing authorisation number follows the format R xxx FI; obligatory additional labelling ’HOMEOPAATTINEN VALMISTE – HOMEOPATISKT MEDEL’ [Homeopathic preparation] or ’ANTROPOSOFINEN VALMISTE – ANTROPOSOFISKT MEDEL’ [Anthroposophic preparation].