Information on the Submission of National Variations

Summary

Pursuant to Section 29 AMG a marketing authorisation holders shall immediately notify the competent higher federal authority of any changes in the information and documents referred to in Sections 22 to 24a and 25b AMG and enclose the corresponding documents.

Furthermore any of the following changes of information pursuant to Sections 10 (outer packaging and labelling of the container), 11 (PL) and 11a (Expert information, SmPC) generally requires approval:

• therapeutic indications, except for an addition or modification which is to be classified into another therapeutic area

• posology

• method and duration of administration

• restriction of contra-indications

• restriction of side effects

• restriction of interactions.

Approval is likewise required for a change

• in active constituents (excluding medicinal active substances) (Section 29 (2a) no. 2 AMG)

• in a pharmaceutical form comparable to the authorised one (Section 29 (2a) no. 3 AMG)

• in the treatment with ionising radiation (Section 29 (2a) no. 3a AMG)

• in pack size (Section 29 (2a) no. 5 AMG.

Changes requiring approval cannot be implemented until the competent higher federal authority has granted its approval.

Changes requiring an application for a new marketing authorisation are listed in Section 29 (3) AMG.

For the submission of a National Variation the Online Variation Submission shoud be used.

In the following you will find some useful explanatory remarks and recommendations.

Online Variation Submission - Recommendations and Documents

Further information on the registration for participation in the "electronic notification" is provided in: Online Variation Submission

Frequent errors

• Date of the printout is missed in the electronic submission.

• Variation has not been notified by the MAH or a power of attorney is missing.

• In case of changes to a manufacturer, its function is not mentioned (release, manufacturing steps).

• If a change of an active substance manufacturer is applied for the address of the latter is incomplete.

• The Expert information (SmPC) for several products has been changed but it is provided only for one product.

• A present-proposed-table is missing or the changes are not highlighted in any other appropriate manner.

• In case of changes of pack sizes, indications, manufacturers, active substances or excipients, only the part of information is presented. To allow efficient processing complete information is required (i.e. complete list of pack sizes/manufacturers/qualitative and quantitative composition, complete textual information of the respective chapter).

• Changes in excipients or shelf life are only stated in the documentation. As a consequence, these changes may not be registered in the AMIS data base. If the shelf life will changed, the former should be mentioned as well.