Swissmedic Guidnce: A Closer Look at Marketing Authorisation Transfers, DHPC, and RMP Submissions
- Sharan Murugan
- Jul 9
- 2 min read
As the Swiss life sciences sector grows increasingly global and collaborative, Switzerland’s regulatory authority, Swissmedic, continues to refine its processes to uphold patient safety and ensure regulatory clarity for the pharmaceutical industry.
This blog explores three recently updated Swissmedic guidance documents that highlight crucial aspects of the Swiss therapeutic product lifecycle:
Transfer of Marketing Authorisation (MA)
Direct Healthcare Professional Communication (DHPC)
Risk Management Plan (RMP) submissions aligned with ICH E2E
Key Insights
A Transfer of Marketing Authorisation (MA) is the official handover of the rights and responsibilities for a medicinal product from one Marketing Authorisation Holder (MAH) to another.
The transferring MAH must submit a signed transfer agreement that clearly states the product(s) covered.
The new MAH must demonstrate its operational capability, including pharmacovigilance responsibilities and compliance systems.
Supporting documents include:
Updated product information reflecting the new MAH.
Evidence of Good Distribution Practice (GDP) compliance if applicable.
Swissmedic outlines a clear procedural checklist and timelines to minimize administrative gaps.
A Direct Healthcare Professional Communication (DHPC) is a targeted safety communication sent by MAHs to healthcare professionals to inform them of new, urgent information about a medicinal product’s safety profile.
The DHPC must be concise, clear, and medically accurate.
It must explain:
The new safety concern.
The impact on prescribing or patient management.
Required actions for healthcare professionals.
DHPCs must be approved by Swissmedic before distribution.
Distribution must cover:
Relevant target groups (e.g., GPs, pharmacists, specialists).
Use of appropriate channels to guarantee prompt delivery.
Swissmedic also outlines the process for publication to ensure transparency with the broader healthcare community.
A Risk Management Plan (RMP) is a detailed document required under ICH E2E guidelines that describes a medicinal product’s known and potential safety risks, with plans to monitor, minimize, and communicate these risks during its lifecycle.
RMPs must follow ICH E2E structure:
Product safety profile
Pharmacovigilance plan
Risk minimization measures
Summary of post-marketing data
New submissions, renewals, or significant safety updates must be accompanied by an updated RMP.
RMPs must be aligned with the Swiss context, referencing Swiss-specific data if applicable.
Sponsors should clearly outline local responsibilities, including safety data collection and reporting mechanisms.
Swissmedic’s updated guidance documents demonstrate its commitment to clear, predictable regulatory frameworks that support safety, transparency, and operational efficiency for MAHs in Switzerland.
Whether transferring a marketing authorisation, preparing a DHPC, or submitting an ICH-compliant RMP, companies benefit from robust procedural clarity. Click ths LINK to know more on these guidances.
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