New Marketing Authorisation for a Medicinal Product at Swissmedic

What requirements must the applicant meet?

Under Art. 10 TPA, it must be shown that the medicinal product is of high quality, safe and effective, that a valid manufacturing, import or wholesale dealing licence is in place, and that the applicant has its domicile, registered office or a branch in Switzerland (Art. 10 para. 1 let. c TPA). Without that Swiss presence, the application is formally inadmissible.

• Quality: GMP-compliant manufacturing, specifications, stability data covering the requested shelf life.
• Safety and efficacy: preclinical data and clinical trials, benefit-risk assessment, risk management plan.
• Licences: manufacturing licence for Swiss production, import licence for imports from third countries.
• Domicile: commercial register extract or equivalent proof for the future marketing authorisation holder.
• Medicinal product information: prescribing information and patient information in German, French and Italian.

How does the procedure unfold step by step?

The procedure runs in five phases: submission via the Swissmedic Portal, formal review, scientific assessment with one or two rounds of questions, preliminary decision and final decision. Each round of questions stops the regulatory clock and starts a response period for the applicant, usually 30 to 90 days.

1. Submit the application electronically via the Swissmedic Portal, including Module 1 with the current forms and the fee invoicing address.
2. Formal review: Swissmedic checks completeness and admissibility. Missing documents lead to an extended deadline, not a refusal.
3. Assessment: quality, preclinical, clinical data and medicinal product information are evaluated in parallel. The outcome is the List of Questions.
4. Response phase: you answer the questions in a consolidated response. A second round of questions is the rule rather than the exception in the standard procedure.
5. Preliminary decision: Swissmedic communicates the intended decision and gives an opportunity to comment.
6. Final decision: authorisation with an authorisation number, approved medicinal product information, dispensing category and conditions, or refusal.

What timelines apply in the standard procedure?

Swissmedic works with timelines that count only regulatory time. The standard procedure for a new active substance provides for around 330 days, split across formal review, two assessment phases and the decision. The applicant's response times sit outside this timeline.

Why do applications fail in practice?

On substance, applications rarely fail for lack of studies but for unsubstantiated bridges: a bioequivalence study using a reference product not authorised in Switzerland, stability data that does not cover the requested shelf life, or an indication worded more broadly than the study population.

• The reference product of a bioequivalence study is not authorised in Switzerland and no bridging data exists.
• The requested shelf life is not covered by stability data under ICH conditions.
• The indication wording is broader than the studied population, without a justification for extrapolation.
• Missing or outdated GMP certificates for the manufacturing sites involved.
• Medicinal product information not aligned with the current Swissmedic template.

What happens right after authorisation?

With the decision you receive an authorisation number and approved medicinal product information, published via AIPS. The authorisation appears in the Swissmedic Journal. The marketing authorisation holder's obligations then begin: pharmacovigilance, variation notifications, renewal after five years, and market access via the Specialities List if reimbursement is sought.