Swissmedic Guidance on Authorisation Renewal, Status Changes and Scientific GMDP Meetings

Sharan Murugan
1 hour ago
3 min read

Swissmedic has issued two guidance documents that provide important regulatory requirements for companies holding medicinal-product authorisations or establishment licences in Switzerland.

One guidance covers renewal, discontinuation, and changes between the main authorisation and the export licence, while the other describes the process for Scientific GMDP Meetings with Swissmedic.

Together, these guidances provide a structured framework for managing authorisation-related activities and discussing GMDP matters with Swissmedic. Both versions are valid from 1 September 2026.

1. Renewal and Discontinuation of Authorisation or Change of Status

The Renewal and Discontinuation of Authorisation or Change of Status (Main Authorisation/Export Licence) guidance, Version 9.0, describes the rules, procedures, rights, and obligations related to renewal and discontinuation of authorisations.

It covers renewal of authorisation, discontinuation of medicinal products, individual dosage strengths and pack sizes, conversion between main authorisation and export licence, and specific requirements for basic and co-marketing medicinal products.

Renewal of Authorisation

Medicinal products are initially authorised for five years. After this period, a once-only application for extension is required. Following successful renewal, authorisation generally continues for an unlimited period, provided the applicable requirements remain fulfilled.

For products requiring renewal, applications should normally be submitted between one year and six months before expiry. The authorisation holder is responsible for ensuring that the application is submitted within the required timeframe.

Renewal applications should use the applicable Swissmedic form. Variations should be submitted separately rather than being included within the renewal application. Swissmedic may request additional documentation or variation applications where necessary.

Discontinuation and Status Changes

Authorisation holders must notify Swissmedic when distribution of a medicinal product is permanently discontinued. The guidance also covers discontinuation of individual dosage strengths and pack sizes.

It further explains the conversion between a main authorisation and an export licence. An export licence does not permit distribution of the medicinal product in Switzerland or Liechtenstein.

Specific provisions are also provided for basic products and co-marketing medicinal products, together with information on processing times, fees, and publication of relevant decisions.

2. Scientific GMDP Meetings for Establishment Licence Holders

The Scientific GMDP Meetings for Establishment Licence Holders guidance, Version 2.0, explains how companies can request meetings with Swissmedic to discuss GMDP-related questions associated with establishment licences and projects.

The meetings are intended to support early discussion of GMDP issues for projects involving new or modified buildings, facilities, systems, manufacturing processes, technologies, or product classes. Examples include continuous manufacturing, robotic filling lines, rapid microbiological methods, AI-based computer systems, and other new manufacturing technologies.

Application and Meeting Preparation

Companies should submit a written meeting request six to eight weeks before the desired meeting date using the specified application form.

The request should provide establishment and licence information, describe the relevant project or change, clearly define the GMDP topic, and list the specific questions for discussion. An agenda, presentation, and participant information should be provided before the meeting.

Swissmedic reviews the request to determine whether the topic is appropriate for a Scientific GMDP Meeting. Requests may not be accepted when the matter is outside the scope of the meeting or when the company has not sufficiently developed its own proposed approach.

Conduct, Minutes, and Fees

Meetings can be held at Swissmedic premises or by video conference and are led by the responsible licence assessor or inspector. The agenda generally follows the submitted questions and includes an introduction, presentation of the issue, discussion, and agreement on further actions.

Company-requested meetings normally last 1.5 to 2 hours, depending on the scope of the discussion.

The applicant is responsible for preparing the minutes in German or English. Draft minutes must be submitted to Swissmedic within two weeks after the meeting. Following Swissmedic review, the applicant finalises and submits the signed minutes for archiving.

Swissmedic charges applicants for the administrative and scientific work associated with the meeting according to the applicable fee requirements.