Establishment of a simplified registration procedure for homeopathic medicinal products for human and veterinary use
The homeopathic medicinal products differ considerably from other medicinal products by containing a very low level of active principles and the difficulties to apply conventional statistical methods relating to clinical trials to these products. In order to include the homeopathic medicinal products in the legislation of the EU directives, the simplified registration procedure has been introduced. An important objective for inclusion of the homeopathic medicinal products in the European legislation was to establish that the legislation for medicinal products also is in force for these products. Harmonized provisions make free movement of goods that are safe and of good quality possible.
In order to apply for a simplified registration, several conditions have to be fulfilled. The first condition is that the medicinal product fulfills the requirements of the definition of a homeopathic medicinal product i.e.:
- The medicinal product is prepared from homeopathic stock(s). A homeopathic stock can consist of a mother tincture or a glycerol maceration if the raw material is of herbal or animal origin or the substance itself if it is of mineral or chemical origin.
- The medicinal product is prepared in accordance with a homeopathic manufacturing method described in the European Pharmacopoeia or, in the absence thereof, in an Pharmacopoeia officially in use in of the Member States (EU/EFTA).
- A homeopathic medicinal product may contain a number of principles.
Other conditions also have to be fulfilled in order to register a homeopathic medicinal product through the simplified registration procedure. More information on these conditions can be found by visiting the following links:
Homeopathic medicinal products that do not fulfill the provisions for a simplified registration procedure
It is not possible to register all homeopathic medicinal products through the simplified registration procedure. This applies for instance to medicinal products that do not meet the requirements for dilution or pharmaceutical form. For these products, a marketing authorization must be obtained to maintain market access in Norway. Further information can be found in Forskrift om legemidler (legemiddelforskriften) i.e. the Norwegian Medicinal Products Regulation.
The anthroposophical products described in an official pharmacopoeia and prepared according to a homeopathic manufacturing method are to be treated, concerning registration and marketing authorization, in the same way as homeopathic medicinal products. Those anthroposophical products that do not fall within the definition of a homeopathic medicinal product and for which the simplified registration procedure cannot be used, have to apply for a marketing authorization in order to maintain market access in Norway.
Applications submitted before the end of the transition period 12.1.2017
The transition period allows homeopathic medicinal products market access in Norway without Norwegian registration on the basis of a marketing authorization or registration in another EEA country, in accordance to Forskrift om legemidler (legemiddelforskriften) §2-1 i.e. the Norwegian Regulation on Medicinal Products. In order to place a homeopathic medicinal product that fulfill the provisions for simplified registration on the market after the transition period ends 12.1.2017, an application must be submitted to the NoMA or the product must be registered by the NoMA. If an application is received within the mentioned date, the homeopathic medicinal product may be placed on the market on the grounds of the submitted application until the product is registered or the application is refused.
Please note that the homeopathic medicinal product must fulfill the provisions for simplified registration in order to be sold on the grounds of submitted application cf. the Norwegian Regulation on Medicinal Products "legemiddelforskriften" § 3-21. In addition these products has to be registered in another EEA country.
NoMA will publish a list of homeopathic medicinal products allowed to be placed on the market in Norway on the NoMA website within the first quarter of 2017. The list will be updated on a regularly basis. This entails that all homeopathic medicinal products currently on the Norwegian market can be sold on the same conditions as today until 3 months after the list is published. Thereafter, only homeopathic medicinal products on the mentioned list published on the NoMA website will be allowed access to the Norwegian market.
Applications submitted after 12.1.2017
For applications received after 12.01.2017 the timelines for assessment as described in the next paragraph applies. If the homeopathic medicinal product is registered by NoMA access to the Norwegian marked will be granted from the date of registration.
Timelines for assessment of applications
The NoMA shall make an initial review on the validity of the application, and whether the application satisfies the legislative provisions or not. If the application does not fulfill the requirements and the provisions for the simplified registration procedure, the NoMA will ask the applicant to provide supplementary information or to withdraw the application.
The assessment of the application has a timeline of 210 days from the date the application for registration is accepted for assessment. Within the frame 210 days the NoMA shall either accept the medicinal product for registration or refuse the application for registration. If NoMA asks the applicant to correct insufficiencies in the application, a clock-stop shall be initiated.
The registration fee for a homeopathic medicinal product is NOK 1000. The fee covers all dilutions of one pharmaceutical form of a product. NOMA will send an invoice based on the received application. The invoice will be directed to the applicant, unless another recipient has been listed in the cover letter of the application. Any invoice references PO number or similar must be stated in the cover letter. Payment is due 30 days from the invoice date.
Measures for manufacturing, import and distribution of homeopathic medicinal products
The provisions regarding manufacturing, import, supply and retail through pharmacy etc applies equally for homeopathic medicinal products as for other medicinal products.