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Advice of BfArM regarding the use of electronic application forms (eAF) as of 1 January 2016

Since 1 January 2016 important changes have to be observed by applicants. BfArM wishes to call pharmaceutical companies' attention to the following essential modifications.

  1. According to the eSubmission Roadmap of 1 October 2014, agreed upon jointly by HMA and EMA, the electronic application forms (eAF) have to be used as of 1 January 2016, for

    - marketing authorisation applications and traditional herbal product registrations
    - renewal applications for authorised and registered products
    - variations

    for all application types. These rules are applicable to all DCP/MRP applications and following regulatory activities as well as for purely national procedures and following regulatory activities.

    After 1 January 2016, the previously provided forms in MS-Word format will no longer be available. Also after this date, BfArM will accept applications only if entirely completed eAFs are part of the submission.

  2. So far exempted from these rules are:

    - registration applications according to Section 38 AMG
    - marketing authorisation applications and renewal applications for parallel imports und
    - renewal applications for registrations according to Section39 sub-section 2c AMG.

  3. In addition, after 1 January 2016, BfArM will no longer provide MS-Word forms for “Änderungsanzeigen” according to Section 29 AMG. After this date, the compilation of such national variations according to Section 29 AMG, i.e. changes and notifications regarding products not subject to the variation regulation, will only be possible using the PharmNet.Bund-Portal.

  4. The PharmNet.Bund-Portal will further be used to announce new use of so-called "Standardzulassungen" according to Section 67 sub-section 5 AMG and any notification of changes thereafter.

Date 2016.02.09