How a medicine reaches the Swiss market

The procedure in nine steps

The authorisation route follows a defined sequence of submission, formal validation, scientific review, questions and answers, preliminary decision and final decision. The FOPH reimbursement procedure is separate and may partly run in parallel; only final SL listing requires Swissmedic authorisation.

1. Pre-submission meeting with Swissmedic: clarify the procedure type, the indication wording and any dossier gaps before money goes into a submission.
2. Submission of the dossier in CTD format, Modules 1 to 5, with a Swiss-specific Module 1: application forms, product information texts in the official languages, details of the authorisation holder.
3. Formal validation: Swissmedic checks completeness and competence. An incomplete dossier is rejected before any scientific assessment starts.
4. Scientific review of quality, non-clinical and clinical data and of the product information, usually by several units in parallel.
5. List of questions to the applicant, with a deadline for answers. That answering time runs on the applicant's clock, not on the Swissmedic clock.
6. Preliminary decision (Vorbescheid): the provisional assessment. The applicant has the right to comment on it, including when the tendency is negative.
7. Authorisation decision with the approved product information, the patient information leaflet, the dispensing category and the authorisation number.
8. Batch release by Swissmedic where prescribed, in particular for vaccines and blood products.
9. Optional: application to the Federal Office of Public Health for listing on the specialities list, so that basic insurance reimburses the medicine.

An initial authorisation is generally valid for five years. After renewal it is normally valid without a time limit; time-limited authorisations and notification procedures follow separate rules. Changes to the indication, manufacture or product information are submitted separately.

How long does the standard procedure take?

For a standard human-medicine application, Swissmedic's time-limit guidance allocates 330 days to the authority and up to 210 days to the applicant, totalling 540 calendar days in the planned process. Interruptions, additional requests and other procedures can change the actual elapsed time.

The Swissmedic clock stops while questions are outstanding. Answering a list of questions quickly and completely shortens the total duration more than any process improvement on the authority's side. Incomplete answers trigger a second list of questions and typically cost several months.

Accelerated, foreign-decision and temporary routes

Alongside the standard route the Therapeutic Products Act provides several variants: the accelerated authorisation procedure, the procedure with a prior foreign authorisation under Art. 13 TPA, the temporary authorisation under Art. 9a TPA, and simplified routes for well-established substances and complementary medicines.

• Accelerated authorisation procedure: for medicines against serious, disabling or life-threatening diseases where a major therapeutic benefit is expected and no or only inadequate alternatives exist. The applicant must request and justify it.
• Procedure with a prior foreign authorisation under Art. 13 TPA: Swissmedic may take account of the assessment results of comparable foreign authorities such as EMA or FDA where the requirements are equivalent. It does not replace the review, but it reduces its scope and duration.
• Temporary authorisation under Art. 9a TPA: available for life-threatening diseases with an incomplete data set, combined with conditions and the duty to submit the missing data.
• Simplified authorisation for medicines with well-established active substances, for complementary and herbal medicines, and for medicines for rare diseases with orphan drug status.

The authorisation holder needs a registered office, branch office or domicile in Switzerland

Under Art. 10 TPA the applicant must have a registered office, a branch office or a domicile in Switzerland. A manufacturer with no Swiss presence cannot hold an authorisation itself and therefore has to appoint a Swiss authorisation holder.

That rule created a business model of its own: companies that act as authorisation holder for foreign manufacturers. The role is not a letterbox. The holder carries regulatory responsibility for the product information, the variation applications, pharmacovigilance, the reporting duties and all contact with Swissmedic.

This is why the Swissmedic export, and this directory with it, names a Swiss company as authorisation holder for every medicine, even where development and manufacturing happen entirely abroad.

What the procedure costs

Fees follow the Swissmedic fee ordinance and, for an authorisation application with a new active substance, run in the tens of thousands of francs. On top of that come annual fees for maintaining the authorisation and separate fees for every variation application.

The authority fee is rarely the largest item in an authorisation project. Writing and maintaining the dossier, translating the product information into the official languages, packaging artwork and setting up pharmacovigilance usually cost considerably more. The rates in force are set out in the fee ordinance.