Guidance on renewal applications for parallel import authorisations

The marketing authorisation is valid for five years from the date of issue of the first marketing authorisation for parallel import (hereinafter referred to as “parallel import authorisation”) of the concerned medicinal product. It may be renewed for further periods of five years.

Renewal of parallel import 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 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 parallel import 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.

The application form “Application form for renewal of parallel import authorisations” (in Danish only) and information regarding submissions, is available on the Danish Medicines Agency website.

Contents of the application

The application must include the following documents:

• Application form, duly completed.
• Outer and inner labelling in the applicable QRD template and package leaflet in the applicable QRD template.
• High quality photos of the specimen package from the export country/ies, bearing the name of the applicant, date of application and name of export country. Photos must comply with the following requirements:

• All photos must be of high quality and reflect colours correctly
  • Text and symbols must be legible
  • All parts of the outer packaging must be visible.
  • All parts of the inner packaging must be visible. Both sides of blister cards must be visible.
  • All sides of the medicinal product, e.g. the tablet must be visible. Size, print/marking, scoreline, colour etc. must be clearly visible on the photos, e.g. by using a caliper and enlargement
  • The complete package leaflet must be legible.
• Please note that, the Danish Medicines Agency will have the right torequest an original specimen package from the applicant, so this may be assessed. This may prolong the assessment time.

• Regarding medicinal products where the directly distributed medicinal product has been deregistered, a proposed revised summary of product characteristics, if relevant. All proposed changes should be indicated via tracked changes.