07.12.2015 - In future, applications to change the name or domicile of the authorisation holder must be made at the same time as the application to change the name or domicile stated in the establishment license. If the holder of the establishment license is also the authorisation holder, it must notify the relevant change under point 1 of the Application form for an establishment license – Medicinal products. In addition, Additional sheet F, Application for an establishment license – Medicinal products must be completed and submitted with the application to change the name or domicile stated in the establishment license. No further documents are required for the application to change the name or domicile of the authorisation holder.
In conjunction with this change, the process for transferring authorisations has also been revised.
The following new rules apply to applications to change the name and domicile of the authorisation holder and to transfer the authorisation:
Transitional regulation for packaging elements
If the company makes use of the transitional regulation in the future, it is the company's responsibility to produce an adhesive label and to comply with the transitional period (a maximum of one year). In this case it is no longer necessary to submit labels to Swissmedic.
Change of product name
It is no longer possible to change the product name when an application is made to transfer the authorisation or to change the name of the authorisation holder. A separate application, which is subject to a fee, must be submitted to the Authorisation section at Swissmedic. This submission is governed by the deadlines stated in the Administrative Ordinance "Time limits for authorisation applications".
Modification of the logo or corporate design
Simultaneous modification of the logo or corporate design as part of an application to transfer the authorisation or to change the name of the authorisation holder will in future be the responsibility of the authorisation holder. This means that it is not necessary to submit any documentation to Swissmedic for this purpose provided that the logo or corporate design has already been approved by Swissmedic at an earlier date.
If an application involving the respective packaging elements is subsequently submitted, the accompanying letter must state that the authorisation holder has already implemented the changes on its own responsibility.
If, on the other hand, the future logo or corporate design has not already been approved by Swissmedic, a separate application must be made to the Authorisations division of Swissmedic and this will attract a fee.
Further information is provided in the Guidance Document on "Transferring an authorisation and changing the name or domicile of the authorisation holder" on the Swissmedic website.
The above changes will enter into force on 1 December 2015.
Modification of the procedure for applications to change the name and domicile of the authorisation holder and for transferring authorisation