Swissmedic’s Guidance: Authorisation of Co-Marketing Medicinal Products

Companies increasingly turn to co-marketing partnerships in today’s highly competitive pharmaceutical landscape to expand product reach, optimise resources, and accelerate market penetration. However, the regulatory complexity of such collaborations requires clear guidelines to ensure product safety, quality, and transparency.

To address this, Swissmedic—Switzerland’s therapeutic products regulatory authority—has released a dedicated guidance document titled “Authorisation of Co-Marketing Medicinal Product.” 

This guidance offers essential instructions for marketing authorisation holders (MAHs) seeking to share commercial rights for identical medicinal products under different brand names.

Co-marketing involves multiple MAHs commercialising the same medicinal product, with identical formulations and manufacturing, under different brand names. Unlike co-licensing, co-marketing allows each company to hold a separate marketing authorisation for the product, provided all regulatory requirements are met.

Swissmedic permits co-marketing for products authorised via either the ordinary or simplified procedures under the Medicinal Products Licensing Ordinance (MPLO), but excludes those authorised via notification or temporary authorisation.

Core Requirements and Procedures

• Mutual Agreements Between MAHs

  Both the original MAH and the co-marketing partner must enter a written agreement confirming the scope of the co-marketing relationship. This agreement is not submitted to Swissmedic but must be made available upon request.

• Application Submission

  • The co-marketing MAH must submit a complete authorisation application, including:

    • A cover letter identifies the co-marketing relationship.

    • A declaration confirming that the product is identical in composition, manufacturing process, and packaging specifications to the reference product.

  • A Module 1 dossier is required, while Modules 2 to 5 can reference the reference product, provided there is access.

• Product Labelling and Information

  While the co-marketed product can use a unique brand name, the product information (e.g., Patient Information Leaflet and Summary of Product Characteristics) must reflect identical content to the reference product, with only minor brand-specific changes.

• Life Cycle Management

  Any changes to the original (reference) product, such as variations, renewals, or safety updates, must be mirrored in the co-marketed product without delay. Swissmedic requires tight coordination between the two MAHs to maintain alignment throughout the product lifecycle.

• Discontinuation of Reference Product

  If the reference product’s authorisation is withdrawn, the co-marketing product may also face cancellation unless an independent dossier is submitted

The transparency and consistency required by Swissmedic demand robust coordination and communication between partnering MAHs. Failure to align lifecycle changes could lead to compliance risks or market disruptions.

For those interested in the full technical details, the official guidance document can be downloaded directly from Swissmedic: Authorisation of Co-Marketing Medicinal Product (PDF)