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Home / Activities / Registration / Homeopathic Medicinal Products

Homeopathic Medicinal Products

 

Introduction

A homoeopathic medicinal product is defined in European legislation (Article 1 Directive 2001/83/EC as amended) as:

"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 Member States. A homeopathic medicinal product may contain a number of principles".

Homeopathic Medicinal products are distinct from other types of medicines, such as herbal medicinal products or pharmaceutical products, although they can be prepared from these sources. This distinction comes from the methods used in their preparation as well as the principles on which they are prescribed.

Preparation of homeopathic medicines involves the use of minute amounts of substances, which are dissolved, further diluted and mixed in a manner designed to activate their healing potential, while concomitantly eliminating side effects; which would arise from using the original substances.

Authorisation of homeopathic medicinal products

The authorisation of homeopathic medicinal products is based on Directive 2001/83/EC as amended  and Directive 2003/63/EC. Taking into account the unique nature of homeopathic medicines, (high dilution factor),  Directive 2001/83 EC as amended makes provision for a simplified registration procedure for homeopathic medicinal products for human use, to be implemented in Member States. The directive outlines the criteria that must be satisfied in order for a homeopathic medicinal product to be eligible for registration. The articles relevant to homeopathic medicinal products include articles 13 - 16, 68 and 69 of Directive 2001/83/EC as amended.

Manufacturing of homeopathic medicinal products requires a manufacturing licence.  Bringing homeopathic products into Malta and placing them on the market requires a company to have an importer's licence (if being imported from countries outside the EU/EEA) or a wholesale dealer's licence.  More information on requirements for these licences can be found here.

Articles 13 and 14 of Directive 2001/83/EC, as amended, have been implemented into the national legislation as per article 32 of the Medicines Act 2003, as amended.  These articles describe the simplified registration of homeopathic medicinal products that fall under the definition above.

Certain criteria must be met be homepathic medicinal products to be eligible for the simplified registration scheme:

  1. the products must be administered orally or externally
  2. the products must not have any specific therapeutic indication appearing on the labelling and any information or promotional material related to that product
  3. the final product must be sufficiently dilute to guarantee the safety of the medicinal product; the 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
  4. the product must be prepared from homoepathic stocks in accordance with a homeopathic manufacturing procedure described in the European Pharmacopoeia, or in the absence of such a description, by any pharmacopoeia used officially in any EU Member State.
  5. the product must bear the scientific name of the stock or stocks from which it is prepared.  If the product is composed of two or more stocks, the scientific names of the stocks may be supplemented by an invented name.

The Homeopathic application form can be found on the Notice to Applicants website.  Guidance on the Module 3 of the dossier for homeopathic medicines is also published. 

Application form for the Simplified registration procedure

The Homeopathic Medicinal Product Working Group (HMPWG) is a European Group dedicated to the discussion on homeopathic medicinal products for human and veterinary use.  More information and guidance documents for the registration of these products can be found on the HMA website.