Market Entry

Our solution for market entry

If you are an international company, with no subsidiary in Switzerland, your partner Medius can act on your behalf.

Various options are possible:

Application for the Marketing Authorisation by Medius

Preparation of Swiss specific application file.
Timely submission and liaison with Swissmedic.
Professional support / management of registration procedure from pre-submission, submission to MA approval and post-approval.
Launch support.

Medius is the holder of an establishment license. As your partner we can apply for the Marketing Authorization on your behalf.

Holding of the Marketing Authorisation by Medius
- or -
Medius acts as Operational Site

Provide Responsible Person and deputy according to Swiss law (FvP).
Establishment and maintenance of local Quality Management System and contract management.
Release of batches to Swiss market.
Provide local Responsible Person for pharmacovigilance.
Preparation, attendance and follow-up of Swissmedic Inspections.
Liason with pre-wholesaler.
Supervision of distribution, performing audits.
Professional handling and reporting of adverse events, quality complaints and medical queries.
Drug regulatory affairs Life Cycle Management.

Medius can act as the licence holder on long-term or as interim solution.

Transfer of the Marketing Authorisation by Medius

If Medius acts as the license holder:

transfer of the Marketing Authorization to your subsidiary can be initiated at any time.
Medius prepares the transfer if you buy an existing Marketing Authorization.

Medius can act as the licence holder and transfer the licence any time as required
by your company.

You may profit also from the significant experience in other activities:

We are pleased to support you in developing the best strategy for your products in licensing and new market opportunities.