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.

Rules - Parallel-imported products

Conditions for granting permission for parallel import for a nationally authorised medicinal products or a medicinal product with an MA based on Mutual recognition(MR) / Decentralised( DC) ) .

• The Icelandic-market product must have an MA in Iceland
• The product must have an MA in the respective exporting country
• The product must contain the same active pharmaceutical ingredient(s) as the Icelandic-market product with no difference in efficacy. If the equivalence of the medicine cannot be proven the application can be declined.
• The importer must have a licence for import and wholesale distribution according to Chapter XII of the Medicines Act No. . 93/1994, as amended and in accordance with provisions of Regulation No 699/1996.
• The distributor in the exporting country must have appropriate licences for wholesale distribution of medicinal products.
• The manufacturing licence of the administrator of the labelling and/or re-packaging of the parallel-imported products.

Data/documentation to be submitted with the application

• The name of the medicinal product in Iceland and in the exporting country.
• The name and address of the party or firm responsible for the marketing of the product in Iceland along with corresponding information concerning the exporting country as well as name of the manufacturer.
• Information on repackaging and/or amended labelling and who will be responsible for it as well as a copy of a manufacturing licence (confirming that the party concerned has a manufacturing licence within the EEA.
• The name, ID number and legal residence of the importer.
• Sample of the product and a mock-up of the packaging from the exporting country. Outer and inner packaging.
• Proposed labelling of the packaging.
• Proposed PIL. Information on the PIL must be in line with information for the Icelandic-market product, but need not be identically worded. Information on the manufacturer and the one responsible for the parallel import and labelling and/or repackaging must also be stated.
• Explanation of any deviations from the medicinal product already on the market in Iceland..

Packaging, labelling etc.:

• Name of importer/MAH of the parallel-imported product, i.e. the one granted permission to place on the market the parallel-imported product along with the name of the one responsible for repackaging and/or labelling (“Samhliða innflutningur og umpökkun/merking:...”)
• New MA number (e.g. : IS/1/YY/XXX/01/SA)
• New Nordic Product ID (Nordic Number) .
• Bar code is preferred.
• IMCA can require labelling of inner packaging if needed..
• Labelling of packaging in a foreign language is permitted provided the information does not contradict the Icelandic labelling..
• Labelling in Icelandic can be affixed onto the foreign text.
• During repackaging not too close a similarity should be observed; thus black/white packaging should be avoided.

Placing on the market:

• After an MA has been granted pricing must be applied for to the Medicinal Product Pricing Committee before the product is placed on the market.

Changes in the parallel-imported product:

• Importer/MAH must observe changes in the PIL and all other changes to e.g. appearance of the product and must then apply for a variation for the product to IMCA accordingly, which assesses the need for amended labelling of the packaging.
• The parallel-imported medicine can stay on the market although the reference product is withdrawn from the market, unless it has been done for safety reasons. It should be noted that the parallel-importer then takes on the responsibility for updating the information on the product in Iceland in line with changes in the exporting country, including SPC and PIL.

Other obligations of the MAH:

The parallel-importer must tend to pharmacovigilance, i.e. report side effects which come to his attention and withdraw batches if defects appear. The importer is not however required to report on risk/benefit of the medicinal product, since he does not have access to such data..

Medicinal products with EU MA:

• An application must be submitted to IMCA, since Iceland is not an EU member. A fee need not be paid to EMEA, nor the parallel import to be reported to EMEA. The product receives new MA number as other parallel-imported products, i.e. only the original EU number on the packaging shows that that the product has been centrally authorised MAH/importer can after having been granted permission for parallel import of a medicinal product with a central marketing authorisation, import the corresponding product from whichever EU country without any additional application, but IMCA must be informed where the product comes from.
   

Parallel import from Estonia, Latvia, Lithuania, Poland, Slovakia, Slovenia, Czech Republic and Hungary.

• If parallel import of a proprietary medicinal product is planned from the above-mentioned countries, the MAH of the product already on the market in Iceland must be notified at least 30 days prior to submission of the application to IMCA, in the eventuality of the product being protected by a patent. 

Notification to the MAH.:

According to information from the EU Commission (Communication from the Commission) dated  30.12.2003, the parallel importer must notify the local representative or the MAH of the medicinal product. The agent/MAH can then request mock-ups for the packaging foreseen (intended) to be used for the parallel-imported product. It is appropriate to submit such reports at least 15 days before the product is intended to be placed on the market.

Application Form: Parallel Import