Guidelines for application for renewal of parallel import marketing authorisation

Updated 09 May 2017

The marketing authorisation is valid for five years from the date of issue of the first marketing authorisation for parallel import of the concerned medicinal product. It may be renewed for further periods of five years.

Renewal of marketing authorisations must be applied for no later than nine months before expiry of the authorisation.

The Danish Medicines Agency will usually consider all parallel import marketing authorisations that are issued to the same parallel importer under the same name and D.Sp.No. collectively. This means that renewal applications must be submitted for all pharmaceutical forms, strengths and export countries at the same time, regardless that some of the associated marketing authorisations expire at a later date.

The fee payable by a company for the assessment of an application is charged and invoiced pursuant to the Danish Executive Order on Fees Payable for Medicinal Products, etc. The fee is payable for each medicinal product and includes all pharmaceutical forms and strengths with the same D.Sp.No. and name applied for at the same time.

Please send the application marked: "Application for renewal of marketing authorisation for parallel import" to:

Danish Medicines Agency
Medicines Licensing & Availability, Workflow
Axel Heides Gade 1
2300 Copenhagen S
Denmark

Contents of the application

The application must include the following documents: 

  • Application form, duly completed.
  • Proposed outer and inner packaging in the applicable QRD template and draft package leaflet in the applicable QRD template. The proposals must be prepared in accordance with the current Danish executive order on labelling, etc. of medicinal products. If this material has been approved previously and no changes have taken place, it is sufficient to refer to this in the application.
  • Scanned images of the specimen package (inner and outer packaging) from the export country, bearing the name of the applicant, date of application and name of export country. The scanned images must be good-quality colour images:
    • All text must be legible
    • Outer packaging: all sides of the carton must be scanned
    • Inner packaging like glass, plastic container etc. must be shown and all text on the label must be legible.
    • Blister card: both sides of the card must be scanned.
    • The tablet/capsule/patch must be scanned so that any print, scoreline etc. are visible. If the print, scoreline etc. on the tablet/capsule/patch is not visible, an enlarged image with visible print or scoreline must be submitted.
    • Place a ruler next to the tablet/capsule/patch before you scan to indicate the size.
    • The package leaflet must be legible.
  • Please note that, if needed, the Danish Medicines Agency has to be able to obtain an original specimen package.
  • In respect of medicinal products whose directly distributed medicinal product has been deregistered, a proposed revised summary of product characteristics indicating changes must be submitted.

    Application form

    Application for renewal of marketing authorisation for parallel import of an already approved medicine (e-form in Danish only)

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