Information about completion of applicant, contact person and representative in the application form

Updated 29 January 2021

This guide specifically concerns the completion of sections 2.4.1, 2.4.2 og 2.4.3 in relation to new applications and the correspondence from the Danish Medicines Agency (DKMA) in relation to granting of the marketing authorisations.

Completion

In general, these sections must be filled in with either
- one name regarding all the countries included in the procedure or
- one name regarding x number of countries and one name regarding y number of countries etc. or
- one name regarding each country.
Thus, do not state any alternative or additional names for a country.

(We also refer to the explanation text at the top of each section in the application form)

Section 2.4.1

The name must be identical with the name of the applicant stated on the first page (= marketing authorisation holder/MAH).

Section 2.4.2

The name of the person with whom the DKMA is to communicate with during the procedure.

Section 2.4.3

The name of the person/company, which the MAH has designated to be their representative.

Note!
According to the explanation text at the top of this section in the application form, the section should only be filled in, if the representative is different from the person with whom the DKMA is to communicate with during the procedure - that is the person stated in 2.4.2.
But if 2.4.3 is left blank, several previous cases have shown that it was unclear whether the applicant wanted the person stated in 2.4.2 as representative or the applicant in fact did not want any representative.

Thus, 2.4.3 should always be filled in, as one of the three following options:

  • If the applicant wants the same person/company as their representative, as stated in 2.4.2, please note "same as 2.4.2".
  • If the applicant wants another person/company as their representative than stated in 2.4.2, please state the name of this other person/company.
  • If the applicant does not want a representative, please note "no representative".

Summary of product charcteristics
The representative, if any, should be stated in section 7, below the MAH, in the Danish summary of product characteristics.

Granting of the marketing authorisation

The marketing authorisation and accompanying summary/ies of products characteristics are submitted to the MAH.

  • For addresses in Denmark via Digital Post.
  • For addresses outside Denmark via a Eudralink package and, therefore, the applicant must state a valid email address in 2.4.1.

If the marketing authorisation holder or the representative is changed during the procedure

If any changes are made regarding the MAH og representative during a procedure, a fully updated application form (and not only the changed pages) must be submitted to the DKMA - before a marketing authorisation can be granted.

 

After granting of the marketing authorisation

For all procedures after granting of the marketing authorisation - e.g. variations, notifications and renewals - DKMA will submit approval- or rejection letters to the contact person stated in the application form.

  • For addresses in Denmark via Digital Post.
  • For addresses outside Denmark via a Eudralink package and, therefore, the applicant must state a valid email address.

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