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What does dispensing category B mean?

Dispensing category B means the medicine may only be supplied against a medical or veterinary prescription, and the prescription may be dispensed repeatedly if the prescriber says so. Roughly half of all medicines authorised in Switzerland sit in this category.

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The legal definition

Category B is defined in Art. 42 of the Therapeutic Products Ordinance (TPO): medicines that may only be supplied against a prescription, without the stricter conditions of category A. Swissmedic sets the category in the authorisation decision, per strength rather than per product.

Classification follows a set of criteria: substance profile, known risk, need for a diagnosis, interaction potential and experience in Switzerland and abroad. A medicine with a new active substance almost always starts in category B or A; reclassification to category D becomes possible only after years of market surveillance and must be applied for by the authorisation holder.

Who may supply category B?

Pharmacies may supply against a prescription, and doctors may dispense directly where the canton allows it. In addition, pharmacists may supply certain category B medicines themselves without a prescription under Art. 24 para. 1 lit. a TPA, provided they document the supply.

  • Pharmacy with a valid prescription: the standard case, repeatable if the prescriber notes it.
  • Pharmacy without a prescription: only for the substances and indications on the Swissmedic list under Art. 45 TPO, with a documentation duty.
  • Direct dispensing by doctors: governed by cantonal law, permitted in most German-speaking cantons, heavily restricted in Geneva, Neuchâtel, Vaud, Basel-City and Ticino.
  • Hospital pharmacy: supply to its own patients as part of treatment.

B compared with A, D and E

A, B, D and E differ along two axes: prescription status and point of supply. A and B are prescription only, D and E are not. Category A prescriptions may not be repeated, category B prescriptions may. D requires specialist advice in a pharmacy or drugstore, E requires none.

B compared with A, D and E
CategoryPrescriptionPoint of supplyExamples in the directory
Ayes, not repeatablePharmacyNarcotics, strong opioids
Byes, repeatablePharmacy, direct dispensingAntibiotics, antidepressants, statins
Dno, advice requiredPharmacy, drugstoreIbuprofen generics, decongestant nasal sprays
EnoAll points of saleGlucose tablets, some herbal teas

The former category C (pharmacy supply without a prescription) was abolished by the revision of the Therapeutic Products Act on 1 January 2019. Swissmedic reclassified the roughly 500 affected products into categories B or D by 2022. If an older source still mentions category C, it is out of date.

Where to check the category of a medicine

The authorisation decision is binding, and three sources make it verifiable in practice: the monthly Swissmedic list of authorised medicines, the product information on swissmedicinfo.ch, and the pack itself, which carries the category in print.

  1. This directory: open the medicine's detail page and read the dispensing category field in the facts table.
  2. Swissmedicinfo: open the product information and read the dispensing category section at the end of the document.
  3. Pack: the category is printed next to the authorisation number.

Watch out for products with several strengths: the category can differ per strength. In the Swissmedic export that appears as the combination B/D. A familiar pattern is proton pump inhibitors, where the low strength sits in D and the high strength in B.

Frequently asked questions

Does dispensing category B require a prescription?

Yes. Category B medicines may only be supplied against a medical or veterinary prescription. The prescription is repeatable if the prescriber notes it. Exception: medicines on the list under Art. 45 TPO may be supplied by a pharmacy after specialist advice without a prescription.

What is the difference between dispensing categories A and B?

Both are prescription only. A category A prescription may not be dispensed repeatedly, a category B prescription may. Category A covers medicines with a raised misuse or safety risk, such as narcotics and strong opioids.

Why does dispensing category C no longer exist?

The revision of the Therapeutic Products Act abolished category C on 1 January 2019, to strengthen the role of the pharmacy and simplify the classification. Swissmedic reclassified the affected products into categories B or D.

Can an authorisation holder apply for reclassification?

Yes. The holder may ask Swissmedic for a reclassification, for example from B to D. The application needs a safety rationale for self-medication, market surveillance data and revised patient and product information. The procedure carries a fee.

Sources

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