1. Provisions regarding application for simplified registration

  • ​​The medicinal product is a homeopathic medicinal product as defined in The European Pharmacopoeia.
  • ​The route of administration is described in the European Pharmacopoeia, or if not found there, in a pharmacopoeia officially in use in a Member State.
  • ​No therapeutic indication appears on the labelling of the medicinal product or in any information relating hereto.
  • 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/homeopathic stock.
  • In order to be used in food producing animal species it is required that all the substances included in the manufacturing of the homeopathic stock(s) are found in the list for allowed substances in the “Forskrift om grenseverdier for legemiddelrester I næringsmidler for dyr” (national regulation for maximum residue limits for active substances in food producing animals).

The simplified registration procedure is described in “Legemiddelforskriften” i.e. the Norwegian Medicinal Products Regulation, §3-21 to § 3-22, and Directive 2001/82/EC Art 17-18.

2. Application form with enclosures and Supplementary Declaration Forms

There is no specific application form specific for registration of homeopathic veterinary medicinal products.  The application form «Homeopathic medicinal product for human use» can be used. The applicant shall inform the NoMA that the application concerns a homeopathic veterinary medicinal product, referring to Art 17 Directive 2001/82/EC. In the cover letter of the application or in the application form the specie(s) for which the product is intended shall be named. Use one application form for each pharmaceutical form of the product concerned. An application may consist of several degrees of dilution from the same homeopathic stock. Name all dilutions in the application form. Give information on whether the homeopathic medicinal product is registered, registration is applied for or refused in other countries.

Required enclosures:

  • Documentation showing that the applicant is registered in the Companies Registration Office
    in the country concerned
  • Manufacturing License and GMP Certificate. The Manufacturing License shall include a license to produce of homeopathic medicinal products
  • QP Declaration
  • Flowchart where all companies involved in the production of the homeopathic medicinal stocks and final products are included
  • TSE Declaration, where appropriate
  • Registration in other EFTA countries
  • Labeling for packaging material (mock-up)

In order for the competent authority to get easy access to important information about the product, the applicant has to fill in and submit Supplementary Declaration 1-7 with each application. In some cases a Supplementary Declaration may be used for multiple applications, but all 7 Supplementary Declarations should be submitted with each application. Fill inn Supplementary Declaration 2 for each product. For homeopathic medicinal products based on more than one homeopathic stock, state the degree of dilution for each homeopathic stock.

The applicant has to insure that all information in the application form, enclosures and the Supplementary Declaration is correct. After submission of the application, the applicant shall inform the NoMA about any prohibition and any restriction affecting the products covered by the application. All new information regarding the safety of the product shall be submitted. The applicant shall also inform the NoMA about any refusal and withdrawal of application for registration in other countries.

3. Packaging material and Invented Name

​The packaging material shall be in accordance with “Legemiddelforskriftens” i.e. the Norwegian Medicinal Products Regulation, §3-39 and Directive 2001/83/EC Art 69. Mock-ups of the outer and immediate packaging should be enclosed in the application. For more detailed information see the updated version of the Veiledning til bruk ved utforming av merking (National Guideline for designing of packaging material – available in Norwegian only).
If the homeopathic medicinal product is made of one homeopathic stock, the name of the medicinal product shall be the scientific name of the stock followed by the degree of dilution. An Invented Name can be applied on the package if the homeopathic medicinal product consists of dilutions from more than one homeopathic stock. The Invented Name has to be approved by the NoMA. The national guideline for invented names, “Veiledning ved forslag til navn på legemiddel”, is published on NoMAs homepage.

4. Quality

The quality requirements are applicable to homeopathic medicinal products in equal degree as for other medicinal products. Documentation is necessary in order to ensure that the medicinal product maintains pharmaceutical quality and that the production of the medicinal products is consistent and reproducible. See Annex I of the Directive 2001/83/EC for more detailed explanation of the following:

  • scientific name or other given name of the homeopathic stock in a pharmacopoeia , together with the degrees of dilution, pharmaceutical form and administration route
  • information on the quality and the origin of the raw material
  • dossier describing how the homeopathic stock or stocks is/are obtained and controlled
  • dossier describing the manufacturing and control of each pharmaceutical form including a description of the method of dilution and potentization
  • data concerning shelf life including results from stability tests of the product

If the homeopathic stock is of biological origin it should be documented that precautionary measures are taken during production to ensure that the medicinal product does not contain pathogenic agents. There are standards in the European pharmacopoeia that are specific for homeopathic medicinal products. A detailed information can be found on the website of Homeopathic medicinal products working group (HMPWG) and in Notice to Applicants Vol. 6B. 

5. Safety

​Use the regulation in Module 3, Notice to Applicants. Possible insufficiencies have to be justified. The application for registration of homeopathic medicinal products intended for use in food producing species shall contain a proposition regarding the withdrawal time and necessary documentation supporting this proposition. A condition for using the simplified registration procedure for homeopathic medicinal products for food producing animals is that all the substances included in the manufacturing of the homeopathic stock(s) are found in the list for allowed substances in the “Forskrift om grenseverdier for legemiddelrester I næringsmidler for dyr” (national regulation for maximum residue limits for active substances in food producing animals).

6. Justification of homeopathic use

​A homeopathic medicinal product may consist of one or a series of stocks. The way the stock or stocks is/are obtained and controlled has to be in accordance with their homeopathic use/tradition, and this has to be justified based on an adequate bibliography. 

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Publisert: 27.04.2016