According to the Norwegian Regulation on Medicinal Products "legemiddelforskriften" §3-22A a registration of a homeopathic medicinal product in another EEA country may be the ground for registration in Norway. The registration in the other EEA country should comply with the requirements in Directive 2001/83/EC. The applicant is required to have the documentation that makes the basis for registration in the other EEA country available for the NoMA. The NoMA may on particular grounds, require that the applicant submit the documentation that makes the basis for the registration.
Application form including annexes and mock-ups should be submitted, see point 2 and 3 above.
If an assessment report from another EEA country is available, the NoMA encourages the applicant to enclose the report.
The applicant will be requested to submit all documentation, when the NoMA is in doubt if the registration is within the scope of Directive 2001/83/EF. For homeopathic stock of biological origin it is mandatory to submit all documentation according to the Norwegian Regulation on Medicinal Products "legemiddelforskriften" § § 3-21 and 3-22.
Some countries has had transitional arrangements and national adjustments before implementing the simplified registration procedure. Homeopathic medicinal products placed on the market should comply with the requirements in the current Directive regarding safety, quality and homeopathic tradition. A registration granted according to previous arrangements and lower requirements than stated by the current directive will not be considered sufficient.
The NoMA will as a starting point accept the lowest dilutions registered in another EEA country. If you apply for a lower potency/dilution in Norway then registered in the EEA, the NoMA will require that the applicant submit safety documentation.