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Norway welcomes registered homeopathic medicines

09 Dec 2016

On 11 November, the Norwegian Medicines Agency (NoMA) announced its new requirements for the registration of homeopathic medicinal products in Norway under the simplified registration scheme.

For homeopathic medicinal products which fulfill the provisions for simplified registration and which are already marketed in Norway, companies have until 12 January to submit applications in order for the products to stay on the market either until the product is registered or the application refused. Products for which applications are sent to the agency later than 12 January may not stay on the market until the registration is granted.

It is the intention of the regulation to duly take into account products that comply with Directive 2001/83/EC or 2001/82/EC and are already registered in another EEA country. Since there must already be a registration dossier in these countries in accordance with Directive 2001/83, it is not necessary to submit a complete dossier but only the application form and its annexes to NoMA. A quality part, non-clinical part or justification of homeopathic use does not have to be submitted. NoMA will accept as a starting point without additional safety documentation the lowest dilution already registered in another EEA country. In the case of homeopathic stocks of biological origin, safety information will have to be given. NoMa will also accept applications in the old format (pre-CTD), if this was the original basis of the application in another EEA country.

In the first instance, packaging text may be in Norwegian, Danish, Swedish or English, or multilingual including one of those languages. A Norwegian sticker can also be used on existing packaging for other countries to hide the foreign language. Norwegian packaging, or multilingual packaging with Norwegian as one of the languages, will be required within three years.

The registration fee for a homeopathic medicinal product is NOK 1000 (€110), covering all dilutions of each pharmaceutical form of a product.

Once NoMA has made a list of the received applications, it will publish the list of homeopathic medicinal products allowed to be placed on the market in Norway. This list will be updated on a regular basis. Products already on the Norwegian market but not on this list may stay on the market with the same conditions for three months after the list is published.

ECHAMP very much welcomes this simplified and suitable approach to registration in Norway, that takes account of and is proportionate to the type of medicinal products and the size of the sector and the market.

Information on the registration provisions is available in English on the NoMA website. For a copy of the NoMA letter in English, giving further details on how to apply and some practical information on the implementation, please contact pk@noma.no