Swissmedic Guidance on Controlled Substances Company Meetings

Sharan Murugan
2 days ago
3 min read

This guidance, "Guidance on Controlled Substances Company Meetings", issued by Swissmedic and valid from 06 March 2026, outlines the framework for Controlled Substances Company Meetings. These meetings are designed to support companies handling controlled substances or involved in the cultivation of cannabis for medical purposes, enabling efficient interaction with Swissmedic’s Narcotics Division.

Background

Companies dealing with controlled substances must comply with strict regulatory requirements, particularly when applying for or maintaining an establishment licence.

To support compliance and improve efficiency, Swissmedic facilitates structured meetings that allow companies to clarify regulatory expectations. As described in this guidance, these meetings provide a platform for exchanging information, discussing project-related questions, and addressing issues related to narcotics control.

Purpose of Company Meetings

The purpose of this guidance is to establish a clear and consistent process for organizing and conducting company meetings.

These meetings aim to:

Clarify regulatory requirements in advance
Support project planning and implementation
Enable structured dialogue with Swissmedic experts

However, it is important to note that feedback provided during meetings does not replace formal regulatory review or decision-making.

Scope of the Guidance

This guidance applies to meetings related to:

Applications for new or amended establishment licences
Legal obligations associated with controlled substances
Projects involving narcotics control within Swissmedic’s remit

These meetings complement other regulatory interactions, such as scientific or authorization-related meetings.

Application and Submission Requirements

Companies must submit a written request for a meeting 4 to 8 weeks in advance. The application should include relevant administrative and technical details to allow Swissmedic to assess the request efficiently.

Key elements include:

Company and contact information
Details of the licence or application status
Clearly defined questions and topics for discussion
Proposed meeting dates and format (on-site or virtual)
Supporting documents such as agendas and presentations

The submitted information should be concise, focused, and directly related to the issues to be discussed.

Review and Acceptance of Meeting Requests

Swissmedic reviews each request to determine whether the meeting can proceed. As explained in this guidance, a meeting may be rejected if:

The topic falls outside the defined scope
The issue should be addressed through another regulatory pathway
The company seeks advice without presenting its own proposed solutions

If accepted, Swissmedic confirms the meeting details and may request additional documentation before the meeting.

Conduct of the Meeting

Company meetings may take place either face-to-face at Swissmedic premises or via video conference. Swissmedic representatives lead the meeting and follow a structured agenda.

Typically, the meeting includes:

Introduction of participants
Presentation of the issue by the company
Discussion of submitted questions
Summary and agreement on next steps

Only the questions submitted in advance are discussed, ensuring focused and efficient interactions.

Duration and Documentation

Meetings generally last 1 to 2 hours, depending on the complexity of the issues. Following the meeting, the company is responsible for preparing minutes, which must:

Summarize key discussions and outcomes
Include participant details and agreed actions
Be submitted to Swissmedic within a defined timeline

Swissmedic reviews and finalizes the minutes before archiving them as part of the regulatory documentation.

Fees

As outlined in this guidance, fees are charged based on the administrative and scientific effort involved in preparing and conducting the meeting. These fees are applied in accordance with the Swissmedic Fees Ordinance.