Swiss authorisation holder: duties at a glance

Who can be an authorisation holder

Under Art. 10 TPA, an applicant needs a registered office, branch office or domicile in Switzerland and the required establishment licence. A foreign manufacturer without such a Swiss presence cannot hold the authorisation itself and must establish an eligible Swiss presence or appoint a qualified partner.

That is why many internationally known medicines in this directory show a Swiss company as authorisation holder rather than the group that developed the product. The authorisation holder is the legal addressee of every Swissmedic measure.

Duties across the lifecycle

The holder keeps the dossier current, files variations, maintains the product and patient information, runs a pharmacovigilance system, releases batches, notifies market events and pays the annual fee. Each of those duties has its own trigger and its own deadline.

Duties across the lifecycle
Duty	Trigger	Deadline or frequency	Consequence of failure
Variation notification or application	change to dossier, text or manufacture	before implementation, notification or approval depending on class	selling without a valid authorisation basis, Swissmedic measures
Update and publish the product information	new safety data, approved variation	immediately after approval, published on swissmedicinfo.ch	objection, stop of distribution
Report serious adverse reactions	awareness of a case	within 15 days through ElViS	administrative measures, penal provisions of the TPA
Periodic safety reports	grant of the authorisation	at the frequency set by Swissmedic	conditions, suspension
Batch release and quality defects	every batch, every defect	before placing on the market, defects reported immediately	recall, suspension of the authorisation
Notify market events	launch, supply interruption, market withdrawal	as specified by Swissmedic, shortages immediately	objection, official measures where supply is at stake
Annual fee	existing authorisation	yearly	reminder, in extreme cases revocation

An initial authorisation is generally valid for five years and is normally made unlimited after renewal. Swissmedic may still impose a time limit or conditions; notification procedures and authorisations under Art. 9a TPA follow specific rules. The directory shows the published status for each authorisation.

Pharmacovigilance in detail

The holder needs a pharmacovigilance system with a responsible person reachable in Switzerland. For Swiss cases outside notified clinical trials, serious adverse drug reactions are reported within 15 days and non-serious unexpected reactions within 60 days. Periodic reports do not replace these individual-case duties.

A responsible person for pharmacovigilance, reachable in Switzerland.
Standard operating procedures for case intake, assessment and reporting.
Reporting of serious adverse reactions within 15 days.
Periodic safety reports at the frequency set by Swissmedic.
Safety communications to healthcare professionals (DHPC) agreed with Swissmedic.

Authorisation holder and operating licence

Product authorisation and establishment licensing are separate. The licence required depends on the activities actually performed, such as manufacture, import, wholesale or export, and on the contractual allocation of responsibilities. Outsourcing storage does not automatically remove licensing duties; it may instead define a licensed scope that excludes storage.

Every licensable activity requires a responsible person with technical qualifications. Many holders outsource storage and distribution to a logistics partner with its own licence and keep the regulatory responsibility.

Transfer of an authorisation

An authorisation can pass to a new holder. The transfer is notified to Swissmedic, carries a fee and does not change the authorisation number. Product information, packaging material, pharmacovigilance responsibility and all open conditions pass to the new holder with it.

Contractual agreement between the transferring and the acquiring company.
Check that the acquirer meets Art. 10 TPA, including a Swiss registered office, branch office or domicile, the required establishment licence and a pharmacovigilance structure.
Notification to Swissmedic with an effective date and supporting documents.
Update the product information, patient information and packaging material to the new name.
Hand over pharmacovigilance data and ongoing obligations.

In the directory a transfer shows up as the same authorisation number appearing under a different company in the next data export. The authorisation holders index of this directory shows how many authorisations each company holds.

Frequently asked questions

Must an authorisation holder be based in Switzerland?

Yes. Art. 10 TPA requires a registered office, branch office or domicile in Switzerland and the required establishment licence. A foreign manufacturer without such a presence establishes an eligible Swiss structure or appoints a qualified partner to hold the authorisation in its own name.

How fast must adverse reactions be reported?

For Swiss cases outside notified clinical trials, serious adverse drug reactions are reported within 15 days and non-serious unexpected reactions within 60 days. Periodic safety reports are an additional duty and do not replace these case reports.

Is the authorisation holder also the manufacturer?

Not necessarily. The holder is legally responsible for the product, while manufacture may sit with a contract manufacturer in Switzerland or abroad. That manufacturer needs its own operating licence and a GMP certificate.

What does maintaining an authorisation cost?

There is an annual fee per authorisation, plus fees for every variation and for a transfer. The tariffs are set in the Swissmedic fee ordinance. On top of that comes the internal effort for product information, pharmacovigilance and batch release.

What a Swiss authorisation holder must deliver