What is a marketing-authorisation holder?
Zulassungsinhaberin
The legal or natural person in whose name Swissmedic grants the authorisation of a medicine. It carries the legal responsibility for quality, safety, product information and market surveillance of the product in Switzerland. In French: titulaire de l'autorisation. In Italian: titolare dell'omologazione.
The marketing-authorisation holder is the person who files the application and to whom Swissmedic grants the authorisation. It answers to the agency for the product, not the foreign manufacturer. Under art. 10 and 11 HMG it must document quality, safety and efficacy with a complete dossier.
Article 11 HMG lists what the application contains: designation and composition, manufacturing process, details of the manufacturing site, analytical, pharmacological, toxicological and clinical tests, drafts of the professional information and the patient information, and packaging texts. Article 10 sets out the substantive conditions, among them the licences of the sites involved.
The decisive point for foreign companies: art. 10 para. 1 let. b HMG requires the applicant to have a domicile, a registered office or a branch office in Switzerland. An address care of a law firm is not enough; a registered branch or a Swiss company is.
Which licences and named persons does it need?
The authorisation alone only means the product is authorised. As soon as the holder itself imports, wholesales or releases batches, it additionally needs an establishment licence from Swissmedic and a fachtechnisch verantwortliche Person. These are two separate procedures with separate fees.
The Betriebsbewilligung is granted per activity: import, export, wholesale, manufacture and batch release for the market are each listed individually. Swissmedic inspects the site before the first grant and periodically afterwards, as a rule every two to three years, against GDP rules and, depending on the activity, GMP rules.
The fachtechnisch verantwortliche Person must be professionally qualified, have relevant experience and be employed by the site at a level that genuinely covers the job. She decides independently on technical matters and cannot be overruled by management. A part-time arrangement is possible; a purely nominal appointment is not.
- Authorisation per product from Swissmedic, in the name of the marketing-authorisation holder
- Betriebsbewilligung per site and per activity: import, wholesale, batch release, manufacture
- Fachtechnisch verantwortliche Person with qualification, experience and a real workload
- Quality system to GDP, plus GMP where manufacture or batch release is involved
- Swiss domicile, registered office or registered branch under art. 10 para. 1 let. b HMG
Which duties apply after the authorisation?
The grant is where the recurring work starts. The holder maintains the product information, publishes it electronically, runs pharmacovigilance with a contact person in Switzerland, notifies variations, submits periodic safety reports and pays an annual fee per authorisation.
The Arzneimittelinformation consists of the Fachinformation for healthcare professionals and the Patienteninformation in the pack. Both must exist in the three official languages German, French and Italian. The holder is obliged to feed the texts approved by Swissmedic into the AIPS portal, from where they are published publicly on swissmedicinfo.ch. Every approved change has to be carried through there.
Pharmacovigilance requires a contact person responsible for Switzerland whom Swissmedic can reach, a reporting system for suspected adverse reactions with the statutory deadlines for serious cases, a risk management system and the periodic safety reports. Safety signals from abroad must be assessed for their relevance to the Swiss authorisation.
- Keep Fachinformation and Patienteninformation current in German, French and Italian
- Publish through AIPS and therefore on swissmedicinfo.ch with every approved change
- Pharmacovigilance contact person based in Switzerland and reachable by Swissmedic
- Report suspected cases and quality defects within the statutory deadlines
- Annual fee per authorisation plus fees for every variation and renewal
Which Swissmedic procedures and timelines apply?
Swissmedic does not run one procedure but several. Which one fits depends on the active substance, on whether a foreign authorisation exists and on the data available. Realistically the range runs from two months in the notification procedure to around eighteen months in the ordinary procedure with question rounds.
Before filing, a Voranfrage to Swissmedic pays for itself: it settles the type of procedure, the scope of the dossier and the Abgabekategorie. The ordinary procedure has a net review time in the order of 330 days, on top of which sit the periods where the clock stops while the applicant answers questions. Those clock stops are the main reason calendar time regularly comes to 14 to 20 months.
For products already authorised by an EU authority or by the EMA, the simplified authorisation under the VAZV or the procedure with reference to a foreign authorisation under art. 13 HMG come into play. Article 13 obliges Swissmedic to take existing assessment results into account, but it does not replace its own review. Article 9a HMG allows a temporary authorisation subject to conditions where there is an unmet medical need and the data are not yet complete. Certain complementary medicines run through the notification procedure of the VAZV.
| Procedure | Basis | Realistic calendar time |
|---|---|---|
| Voranfrage on the choice of procedure | Swissmedic advice | 1 to 3 months to an answer |
| Ordinary procedure | HMG art. 10, 11 and 16 | 14 to 20 months, about 330 days net |
| Accelerated procedure | Medicinal Products Ordinance | 9 to 13 months, about 140 days net |
| Simplified authorisation | VAZV | 7 to 13 months depending on the dossier |
| Reference to a foreign authorisation | HMG art. 13 | 8 to 14 months |
| Temporary authorisation with conditions | HMG art. 9a | 10 to 14 months, conditions continue |
| Notification procedure, complementary medicines | VAZV | 2 to 5 months |
What does it cost, and what is the faster route?
Fees follow the Swissmedic fees ordinance, the Gebührenverordnung. An application for a new active substance sits in the order of several tens of thousands of francs, simplified procedures markedly below that, and an annual fee per authorisation in the four-figure range comes on top. The current tariff is always the binding figure.
Internal effort exceeds the fee: dossier preparation, translating the texts into three languages, a quality system, the fachtechnisch verantwortliche Person, a pharmacovigilance structure and preparing for the first inspection. A Swiss country organisation of your own with authorisation and establishment licence is a twelve to twenty-four month project, not a three-month one.
That is why transferring an existing authorisation to a new holder is the route that matters in practice. It is a notification to Swissmedic evidencing the domicile, the licences and the assumption of all duties, not a fresh application. The substantive assessment of the product is not repeated, so a transfer is done in weeks to a few months. A market entrant therefore usually takes over or rents a holder instead of building one.
- Define the target product, the Abgabekategorie and the market access you want, including the Spezialitätenliste question
- Settle legal form and domicile: Swiss company, branch office or a service provider under art. 10 para. 1 let. b HMG
- File a Voranfrage with Swissmedic on the type of procedure, the dossier scope and the Abgabekategorie
- Apply for the Betriebsbewilligung and employ the fachtechnisch verantwortliche Person on a binding basis
- Prepare the dossier under art. 11 HMG and produce Fachinformation and Patienteninformation in three languages
- File the application, or notify the transfer of an existing authorisation
- After the grant, publish the texts through AIPS, switch on pharmacovigilance and budget the annual fee
| Route | Cost | Control | Speed | Exit risk |
|---|---|---|---|---|
| Own Swiss subsidiary | High, fixed costs from day one | Complete | 12 to 24 months | Low, the authorisation stays in the group |
| Service provider acts as the holder | Medium, a plannable annual retainer | High, the brand stays with you | 3 to 9 months where an authorisation exists | Low to medium, contract the transfer back |
| Distribution partner holds the authorisation | Low, often with no upfront outlay | Low, the partner owns market access | Fastest, often under 6 months | High, the authorisation does not return automatically on termination |
Frequently asked questions
Does the holder strictly need a Swiss company?
No, but it needs a Swiss connection. Article 10 para. 1 let. b HMG requires a domicile, registered office or branch in the country. That can be your own AG or GmbH, a branch entered in the commercial register, or a service provider that holds the authorisation in its own name.
Is an EU authorisation automatically valid in Switzerland?
No. Switzerland is not an EU member and there is no automatic recognition. Under art. 13 HMG Swissmedic must take existing foreign assessment results into account, which cuts the dossier and the timeline, but a Swiss authorisation procedure of its own remains necessary.
How long does transferring an existing authorisation take?
Usually weeks to a few months. The transfer is a notification to Swissmedic, not a new application: the incoming holder evidences its domicile, its Betriebsbewilligung, its fachtechnisch verantwortliche Person and the handover of pharmacovigilance. The product assessment is not repeated.
What does a Swissmedic authorisation cost?
The amounts are set in the Swissmedic fees ordinance, the Gebührenverordnung. An application with a new active substance sits in the order of several tens of thousands of francs, simplified procedures well below that. An annual fee per authorisation comes on top. The current tariff is the binding figure.
Is authorisation the same as listing on the Spezialitätenliste?
No, these are two agencies and two procedures. Swissmedic grants the authorisation; the Federal Office of Public Health (FOPH) decides on admission to the Spezialitätenliste and therefore on reimbursement by the compulsory health insurance and on the price.