Co-Marketing Medicinal Products in Switzerland
Short answer
A co-marketing medicinal product is identical to an already authorised base product and is marketed only under a different name and by a different marketing authorisation holder. It is authorised through the notification procedure, receives its own authorisation number, and shares the fate of the base authorisation.
What requirements apply?
The base product must be authorised in Switzerland, and the base marketing authorisation holder must consent to the co-marketing in writing. The co-marketing product must be completely identical: the same composition, the same manufacturing sites, the same specifications and the same medicinal product information.
- Valid authorisation of the base product in Switzerland.
- Written consent from the marketing authorisation holder of the base product.
- Identity in composition, manufacturing, testing and dosage form.
- Its own name that creates no risk of confusion and is not misleading.
- Its own marketing authorisation holder with Swiss domicile and the appropriate licence.
- Disclosure of the co-marketing status to healthcare professionals.
How does the notification procedure work?
Co-marketing is handled through the notification procedure under Art. 15 TPA. Swissmedic checks identity with the base product and the formal documentation, rather than re-assessing quality, safety and efficacy. Processing time is significantly shorter than for an ordinary procedure.
- Obtain and document the base marketing authorisation holder's consent.
- Submit the notification referencing the base authorisation number, with a declaration of identity.
- Enclose the medicinal product information and packaging drafts under the new name, identical in content.
- Receive the decision with its own authorisation number.
- Keep track of variations to the base authorisation on an ongoing basis.
How does co-marketing differ from a generic and a parallel import?
A generic is an independent product with its own bioequivalence assessment. A parallel import is the same product from another market, brought into Switzerland through a simplified authorisation. Co-marketing is the same product from the same source, simply under a different name.
| Feature | Co-marketing | Generic | Parallel import |
|---|---|---|---|
| Legal basis | Art. 15 TPA, Art. 15 TPO | Art. 12 TPA | Art. 14 para. 2 TPA |
| Bioequivalence study | no | yes | no |
| Base holder's consent | yes | no | no |
| Own authorisation number | yes | yes | yes |
| Dependency on another authorisation | complete | none | partial |
| Typical processing time | short | long | medium |
What is co-marketing used for in practice?
Co-marketing opens up additional distribution channels: a manufacturer distributes a product itself and simultaneously has a partner offer it under a different name, for example targeting a different audience or a different price position in the Specialities List. Contractually, it needs clear rules on pharmacovigilance, recalls and variations.
Frequently asked questions
Does a co-marketing product need its own studies?
No. Since the product is identical to the base product, Swissmedic does not assess separate quality, safety or efficacy data, only the identity and the formal documentation.
Can the co-marketing product have a different dispensing category?
No. Since the medicinal product information is identical, the same dispensing category applies as for the base product.
Who bears the pharmacovigilance obligations?
Both marketing authorisation holders, each for its own product. In practice this is governed by a pharmacovigilance agreement that sets out reporting channels and deadlines.
Can a co-marketing product be included in the Specialities List?
Yes, via its own application to the FOPH. The price can differ from that of the base product but is subject to the same rules on foreign price comparison and therapeutic cross-comparison.
Sources
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