Pricing: how their fees are built

External providers do not publish fixed prices, because a mandate for one orphan product and a mandate for a twelve-product generics portfolio have nothing in common. What external providers can publish is exactly how the number is built and what moves it.

Last updated: MAH Switzerland

What determines the price of a Swiss MAH mandate?

Six things: how many authorisations, whether a Swiss authorisation already exists, the dispensing category, how many variations the product generates per year, which functions are in scope, and the expected volume of safety cases and orders. Everything else is detail.

The six drivers, and their direction
DriverEffect on the feeWhy
Number of authorisationsUp, but with volume discountEach carries its own annual fee and artwork
Existing Swiss authorisationDownA transfer is cheaper than a new submission
Dispensing category A or BUpMore safety and regulatory work than category D
Variation frequencyUpEach Swiss filing is work and an authority fee
Scope: PV, QA, import, SLUp per moduleEach is a real operational function
Case and order volumeUpPharmacovigilance and logistics scale with volume

Which fee types will appear in your quote?

A quote has at most five lines, and external providers tell you which of them are fixed and which scale. There is no management fee, no percentage of revenue by default and no charge for the quarterly report.

  • Annual holder fee per authorisation. Fixed, invoiced yearly, covers the holder position and routine maintenance.
  • Project fees. Fixed price or hourly for submissions, variations, transfers and SL applications, quoted per project.
  • Pharmacovigilance fee. A base fee plus a per-case component above an agreed volume.
  • Quality and logistics fees. Per batch released, per order, per unit stored, cold chain separately.
  • Authority fees. Swissmedic and FOPH fees passed through at cost, with the invoice attached.

Why no price list?

Because a published price would be either useless or misleading. The same service costs very different amounts for a single category D product with one pack and for a category B portfolio with twenty packs and monthly variations. What external providers guarantee instead is a written fee schedule on a timetable agreed with the selected provider of a scoping conversation.

How to make your mandate cheaper

Most of the cost levers are on your side of the table, and external providers would rather tell you than bill you.

  1. Buy an existing Swiss authorisation rather than filing a new one, where that option exists.
  2. Bundle products into one mandate, because the second file is far cheaper than the first.
  3. Send the providers a complete, current dossier the first time: incomplete files cost review cycles, and cycles cost fees.
  4. Group variations instead of filing them one by one, where the change categories allow it.
  5. Decide the reimbursement strategy before you set European prices, so you do not pay the providers to fight your own price comparison.
  6. Keep pack configurations lean: every pack is artwork, labelling and an SL line.

Contract terms external providers use as standard

  • Annual term with a notice period, not a multi-year lock-in.
  • An exit clause obliging the providers to transfer the authorisation to you or your nominee.
  • A technical or quality agreement as an annex, written to be inspected.
  • Confidentiality in both directions, with conflict checks before signing.
  • Authority fees at cost with documentation, no handling surcharge.

Frequently asked questions

  • Do you work on a percentage of revenue?

    Not as the default. Fee-based pricing keeps the incentives clean and the cost predictable for a small market. Where a client prefers a variable component, for instance in a full commercialisation mandate, external providers agree it explicitly on top of a reduced fixed fee.

  • Are Swissmedic fees included?

    No, and no serious provider includes them, because they are set by federal ordinance and revised periodically. External providers quote them from the current schedule, pay them and pass them through at cost with the invoice attached.

  • How fast do we get a quote?

    Within one working day of having the product list and the dossier status. If the scope needs a call, external providers do the call within that day and send the schedule afterwards.

  • Is there a minimum mandate size?

    One authorisation. Single-product mandates are their most common starting point, and many portfolios began as one product that worked.

Sources

Enquire about Swiss MAH support

Describe your product, dossier status and support needs. Enquiries reach the website operator at info@mahswitzerland.com. Provider qualifications, availability and contracts must be checked separately.

  • Independent information portal
  • Public Swiss sources, independent explanations, and enquiries about external specialist services.

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Get a quote

About 2 minutes. No obligation.

First, a little about your business.

Your answers stay in this page until you send your enquiry.

What would you like to achieve?

Your project

Where can we reach you?

You can go back to review your answers before sending.

* Required fields
Prefer email? info@mahswitzerland.com