Parallel import

If a party other than the marketing authorisation holder, or a party acting on its behalf, wishes to import for distribution a medicinal product that has a marketing authorisation in Iceland, that party shall apply for a parallel import licence. Parallel import is the movement of medicinal products between countries within the European Economic Area (EEA) under a licence issued by the authorities of the importing country.

The authorities of the countries involved in the import verify that the medicinal product is the same as the one already on the market. Only those who hold a licence for the import and wholesale distribution of medicinal products (under Regulation No. 699/1996) can apply for a parallel import licence.

Conditions for granting a parallel import licence for a medicinal product

Parallel import of medicinal products into Iceland is based on Regulation No. 340/2016 on the granting of parallel import licences for medicinal products.

• The reference medicinal product (the originally imported medicinal product) has a valid marketing authorisation in Iceland when the application for parallel import is made.

• The medicinal product has a marketing authorisation in the exporting country.

• The medicinal product contains the same active substance(s) and is the same pharmaceutical form as the reference medicinal product, and there is no difference in therapeutic effect. If it is not demonstrated that the medicinal product is equivalent, the application shall be refused.

• The importer holds a licence for the import and wholesale distribution of medicinal products under Chapter VII of the Medicinal Products Act, No. 100/2020, as amended, and in accordance with the provisions of Regulation No. 699/1996.

• The distributor in the exporting country must hold the required licences for the wholesale distribution of medicinal products.

Documents/information to accompany the application

The documents listed below shall accompany the application. If the application is incomplete, the Icelandic Medicines Agency (IMA) will request updated or additional documents as appropriate, and these shall be sent to IMA within 30 days. If the requested documents have not been received within that time limit, IMA may dismiss the application.

The application shall state the following:

• The name of the medicinal product in Iceland, i.e. the name of the reference medicinal product, and the name of the medicinal product in the exporting country, i.e. the name of the medicinal product for which parallel import is being applied for.

• The name and address of the marketing authorisation holder of the reference medicinal product, together with information on its Icelandic local representative, and the name and address of the marketing authorisation holder in the exporting country, as well as the name of the manufacturer responsible for batch release.

• The name and address of the seller (wholesaler) in the exporting country.

• Information on repackaging (including changes to labelling) and who will carry it out, together with a copy of the manufacturing licence (confirmation that the party concerned holds a manufacturing licence in the EEA).

• The name, ID number and registered address of the applicant (parallel importer).

• Other information required by the application form.

Other documents:

• Samples of the outer and immediate packaging from the exporting country in electronic form.

• A proposal for the labelling of the packaging.

• A statement of any deviations from the reference medicinal product already on the market in Iceland.

IMA will request a sample of the medicinal product when necessary.

Labelling on packs of parallel imported medicinal products when placed on the market

• The name of the licence holder of the parallel imported medicinal product, i.e. the party that has obtained (or is applying for) a licence to market the parallel imported medicinal product.

• The name of the party responsible for repackaging and/or labelling. (Parallel import and repackaging/labelling: ….)

• The licence number of the parallel imported medicinal product issued by IMA when the licence is granted (IS/1/ÁÁ/XXX/01/SA).

• A specific Nordic article number for the parallel imported medicinal product.

• Barcodes are permitted.

• In exceptional cases, IMA may grant an exemption from the requirement for Icelandic labelling on the immediate packaging.

• Labelling in a foreign language is permitted on the packaging provided the information does not conflict with the Icelandic labelling.

• Icelandic labelling may be affixed over foreign text.

Placing on the market

After the parallel import licence has been granted and before the product is placed on the market, an application shall be made for publication in the Medicine Price Catalogue.

Changes to the parallel imported medicinal product

• If changes are made to the Summary of Product Characteristics, labelling or package leaflet of the reference medicinal product, IMA issues new texts for the parallel imported medicinal product and sends them to its licence holder. IMA also sends the licence holder an invoice for the changes in accordance with IMA's tariff of fees.

• The parallel imported medicinal product does not need to be withdrawn from the market even if the reference medicinal product is withdrawn from the market, unless this is done for safety reasons. Please note that the parallel import licence holder is thereafter responsible for updating the information on the medicinal product in Iceland in line with changes in the exporting country, including the SmPC and package leaflet.

Other obligations of the licence holder

The parallel import licence holder shall carry out pharmacovigilance in accordance with the rules in force at any given time, e.g. receive reports of adverse reactions to the medicinal product and report them to IMA within 15 days of receipt, and recall batches if defects are discovered. However, the licence holder of a parallel imported medicinal product is not expected to submit benefit/risk assessment reports for the medicinal product, as it does not have access to such data.

Special provisions for centrally authorised medicinal products

• The application shall be sent to IMA because Iceland is not part of the EU. No fee is payable to the European Medicines Agency (EMA), and parallel import does not need to be notified there. The medicinal product receives a new licence number of the same kind as other parallel imported medicinal products, i.e. only the original marketing authorisation number on the packaging shows that it is a centrally authorised medicinal product. After obtaining a parallel import licence for a centrally authorised medicinal product, the licence holder of the parallel imported medicinal product may import the medicinal product concerned from any EEA country without applying separately, but IMA must be notified of where the medicinal product is sourced from.

• The information in the package leaflet of centrally authorised medicinal products may not be changed. Only information on the parallel importer and the manufacturer responsible for labelling/repackaging shall be added.

Parallel import from certain countries

If it is planned to parallel import a proprietary medicinal product from Estonia, Croatia, Latvia, Lithuania, Poland, Slovakia, Slovenia, the Czech Republic or Hungary, the marketing authorisation holder of the proprietary medicinal product already on the market in Iceland shall be notified at least 30 days before the application for parallel import is sent to IMA, as the medicinal product may be subject to patent protection. (from 1 July 2013)

Notification to the marketing authorisation holder

According to the European Commission (Communication from the Commission) dated 30 December 2003, the holder of a parallel import licence shall notify the local representative or marketing authorisation holder of the medicinal product. The local representative/marketing authorisation holder may then request samples of the packs in the form in which the parallel imported medicinal product is intended to be marketed. It is considered appropriate to send such notifications at least 15 working days before the parallel imported medicinal product is planned to be placed on the market.

Last updated in October 2026

Homeopathic medicinal products

Homeopathic medicinal products are medicinal products prepared from products, substances or compositions called homeopathic stocks. They are also sufficiently diluted to guarantee their safety and may, for example, not contain more than 1/10,000 of the mother tincture or more than 1/100 of the smallest dose of a medicinal product used in conventional medicine.

Traditional herbal medicinal products

Some plants contain substances that can be used to treat diseases. Medicinal products made from these substances are called herbal medicinal products. Even though these are naturally derived substances, some of them can be harmful to patients. Such medicinal products therefore fall under the pharmaceutical legislation, which is consumer protection legislation guided by the quality, safety and efficacy of medicinal products.

Some herbal medicinal products have been in use for a long time and are then classified as traditional herbal medicinal products. To fall under this classification, there must be evidence of use for at least 30 years, of which at least 15 years within the European Economic Area. In addition, traditional herbal medicinal products must be suitable for use without medical supervision and may not be administered by injection.

All medicinal products, including herbal medicinal products, must be granted a marketing authorisation by the Icelandic Medicines Agency (IMA) before they can be placed on the market. However, traditional herbal medicinal products have a special position because of how long they have been in use. For this reason, they can be registered in a simpler way than generally applies to medicinal products. Nevertheless, the necessary requirements for quality, safety and efficacy apply to traditional herbal medicinal products.

The difference between registration and a marketing authorisation lies mainly in the fact that it is not necessary to submit the results of safety studies or to carry out clinical trials, which is required when applying for a marketing authorisation for medicinal products. Because traditional herbal medicinal products have been used for so long, the requirements for studies can be reduced, and reference can instead be made to published scientific articles showing that the traditional herbal medicinal product is not harmful when used as recommended and that, in light of long-term use and experience, the intended effect can be expected.

However, long-standing traditional use does not rule out the need to consider the safety of a traditional herbal medicinal product before registration is approved. IMA may therefore request additional information if it is considered necessary to assess safety.

Although the European Medicines Agency is not involved in the registration of traditional herbal medicinal products, it has a special scientific committee, the Committee on Herbal Medicinal Products (HMPC). This committee collects and assesses scientific information with a view to promoting harmonisation within the European Economic Area.

Detailed information on how to register traditional herbal medicinal products can be found in the "Notice to Applicants, Volume 2A, Chapter 1" under "Procedure for traditional herbal medicinal products (traditional-use registration)".