Parallel importation
If someone different from the MAH or his local representative wishes to import for distribution a medicinal product with an MA in Iceland he must apply for a permission for a parallel import. Parallel import is movement of medicinal products between countries with the European Economic Area (EEA) based on a marketing authorisation granted by authorities in the import country. Authorities in the importing countries verify that the product is identical to or have no significant therapeutical differences from the one allready on the market. Only those with appropriate licences for wholesale distribution of medicinal products (according to Regulation No 699/1996) can apply for permission for parallel import.
Parallel import of medicinal products to Icelandi is based on regulation 340/2016 on granting license for parallel importation of medicinal products.
- Marketing authorisation of a directly imported medicinal product is a prerequisite for parallel import of a medicinal product.
- The parallel imported medicinal product needs to have a valid marketing authorisation in the export country.
- The medicinal product contains the same active substance and has the same therapeutic effect as the directly imported medicinal product.
- The importee has a license for importation and wholesale distribution of medicinal products in Iceland.
- The wholesaler in the export country has valid license for wholesale distribution in the export country.
The application needs to include the following:
- Cover letter
- Names of the directly imported medicinal product and parallel imported in the export country.
- Name and address of marketing authorisation holder for the directly imported medicinal product as well as the representative for that product. Name and address of the marketing authorsation holder of the parallel imported medicinal product as well the name of the producer which certifies batch release.
- Name and address of the wholesaler in the export country.
- Documentation from the company(s) that perform the re-labeling/repackaging on their valid manufacturing authorisation, granted by the regulatory authorities in the country/countries where the re-labeling/repackaging are performed.
- Name, social security number and address of the applicant.
- Example of the labeling (mock-ups) of the inner and outer packaging from the export country in digital format.
- Draft of the labeling (mock-ups) on the product to be sold in Iceland.
- Report on any deviation from the directly imported medicinal product.
- Other information requested on the application form
Homeopathic medicines
Homeopathy is a system of complementary medicines in which disease is treated by minute doses of substances that in large quantities would produce symptoms of the disease.
Application for importation, distribution and sale of homeopathic medicine
Traditional herbal medicines
Herbal medicines contain one or more active ingredients which are prepared by treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation from cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried form, but sometimes fresh. Pure substances isolated from nature are not considered to be herbal medicines.
Herbal Medicines are only to be used orally or as a localised treatment on skin or mucosa. It is not allowed to mix prescription based medicines with herbal medicines.
Detailed information on how to register traditional herbal medicines is available in „Notice to Applicants" in volume 2A, chapter 1 under Procedure for trational herbal medicinal products (traditional-use registration) on the European Commission site.