Submission options for applications regarding parallel import and parallel trade

Parallel import

Application for authorisations

Applications for marketing authorisations for parallel import (hereinafter referred to as “parallel import authorisations”) may be submitted electronically via DKMAnet at dkmanet.dk (see the guidance “Introduction to electronic applications for parallel import” on the Danish Medicines Agency).

Notification of changes

Notification of changes to parallel imported medicinal products may be submitted via CESP (see below) or via EudraLink/email to Send an email. The following must be stated in the “Comment” field for CESP submissions or in the subject line for EudraLink/email submissions: “Underretning om ændring – product name – marketing authorisation number(s)”

The submission should include a completed “Form for notification or application of changes to parallel imported medicinal products” together with relevant documentation. The application form specifies which documentation should accompany the submission.

Variation applications

Applications for variations to parallel imported medicinal products may be submitted via CESP (see below) or via EudraLink/email to Send an email. The following must be stated in the “Comment” field for CESP submissions or in the subject line for EudraLink/email submissions: “Variation – product name – marketing authorisation number(s)”.

The submission should include a completed “Form for notification or application for changes to parallel imported medicinal products” together with the relevant documentation. The application form specifies which documentation should accompany the submission.

Renewal of parallel import authorisations

Applications for renewal of parallel import authorisations may be submitted via DKMAnet, CESP (see below), or EudraLink/email to Send an email. The following must be stated in the “Comment” field for CESP submissions or in the subject line for EudraLink/email submissions: “Forlængelse – product name – marketing authorisation number(s)”.

The submission should include a completed “Application form for renewal of parallel import authorisations” together with relevant documentation. “Guidance on renewal applications for parallel import authorisations” is available on the Danish Medicines Agency website and describes which documentation should accompany the submission.

Parallel trade

Application for authorisations

Applications for authorisations for parallel trade should be submitted via CESP (see below) or via EudraLink/email to Send an email.

An original specimen package must be submitted together with the application. The physical specimen package should be sent to: Danish Medicines Agency, Axel Heides Gade 1, 2300 Copenhagen S, Denmark.

Application and notification of changes

Applications and notifications of changes concerning parallel traded medicinal products should be submitted via CESP (see below) or via EudraLink/email to Send an email.

The following must be stated in the “Comment” field for CESP submissions or in the subject line for EudraLink/email submissions: “Ændring (VET) – product name, pharmaceutical form and strength(s) – marketing authorization number(s) – country X”.

The submission should include a completed “Application form for a parallel traded authorisation for notification of changes to veterinary medicinal products that are parallel traded” together with the relevant documentation. The application form specifies which documentation should accompany the submission.

Submission of a specimen package / high quality photos of a specimen package

An original specimen package from the exporting country is required as supporting documentation for most parallel import applications, cf. the Guidance on Parallel Import and the various notification/application forms and renewal guidance mentioned above.

For applications where a physical specimen package is submitted, it should be sent to:

Danish Medicines Agency, Axel Heides Gade 1, 2300 Copenhagen S, Denmark. Photos may be submitted via CESP (see below).

For applications where high-quality photos are submitted, these may be submitted together with the application form via DKMAnet, CESP, or EudraLink/email. In applications for parallel import authorisations, photos should be attached in DKMAnet using the field “Eventuelt transportbeskrivelse som vedhæftet fil”. For renewal applications submitted via DKMAnet, photos should be attached as “Bilag”.

For applications submitted through DKMAnet, photos may also be submitted separately via EudraLink/email to Send an email. The case number must be included in the subject line.

Specific requirements for submissions via CESP

For submissions via CESP relating to applications for parallel imported or parallel traded medicinal products, “Parallel Import” must be selected as the “Regulatory Activity”.

A brief guide is available here. For general guidance on the use of CESP, please refer to cespportal.hma.eu.

Overview of submission options

The table below provides an overview of the available submission routes for parallel import and parallel trade.