Licenses for Parallel Import

Application Form for Parallel Import

Parallel import - guidelines/information

Conditions for granting permission for parallel import of medicinal products.

  • The Icelandic-market product must have a marketing authorisation (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 is not proven the application will be declined.
  • The importer must have a licence for import and wholesale distribution according to Chapter XII of the Medicinal Products Act No 93/1994, as amended and in accordance with provisions of Regulation (EU) No 699/1996.
  • The distributor in the exporting country must have appropriate licences for wholesale distribution of medicinal products.

 

Data/documentation to be submitted with the application

  • Application form.
    1. The name of the medicinal product that has already received marketing authorisation in Iceland and the name of the intended parallel imported product in the exporting country.
    2. The name and address of the marketing authorisation holder of the product in Iceland and of his Icelandic representative along with corresponding information concerning the exporting country as well as the name of the manufacturer responsible for batch release.
    3. The name and address of the distributor (wholesaler) in the exporting country.
    4. 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).
    5. The name, ID number and legal residence of the applicant (parallel importer).
    6. Other information required in the application form.
  • Sample of the product and a mock-up of the inner and outer packaging from the exporting country. Preferably mock-ups should be sent by email to the address mockups@ima.is. Confirmation of the email should be attached to the application.
  • Proposed labelling of the packaging.
  • Proposed product information Leaflet (PIL) that should contain the same as the PIL for the already marketed product. Information on the PIL should be updated to include manufacturer in the exporting country. Information on marketing authorisation holder should be replaced by information on the parallel importer and on the manufacturer responsible for labelling and/or repackaging of the parallel imported product.
  • Explanation of any deviations from the medicinal product already on the market in Iceland.

 

Labelling of the parallel imported product when placed on the market:

  • Name of importer 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:...Name”).
  • New licensing number (e.g. : IS/1/YY/XXX/01/SA).
  • New Nordic Product ID (Nordic Number).
  • Bar code is accepted.
  • IMA 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.

 

Placing on the market:

  • After a parallel import license has been granted and  before the product is placed on the market, pricing must be applied for at the Icelandic Medicine Pricing and Reimbursement Committee.

 

Changes in the parallel imported product:

  • Parallel importer 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 IMA 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 from then on, the parallel importer takes on the responsibility for updating the information on the product in Iceland in line with changes in the exporting country, including SmPC 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.

 

Special conditions concerning medicinal products with EU MA:

  • An application must be submitted to IMA, since Iceland is not an EU member. A fee need neither be paid to EMA, nor the parallel import to be reported to EMA. The product receives new licensing number as other parallel imported products, i.e. only the original EU number on the packaging shows that the product has been centrally authorised. Parallel 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 IMA must be informed where the product comes from.
  • The PIL of medicinal products with EU MA should not be changed. Only information on the parallel importer and on the manufacturer responsible for labelling and/or repackaging should be added.
     

Parallel import from Estonia, Croatia (from 1 July 2013), 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 IMA, 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 work days before the product is intended to be placed on the market.

Updated 21 November 2013.