Expiry dates

The shelf-life of a medicinal product is determined by the manufacturer on the basis of stability studies. The data are submitted to Swissmedic as part of the authorisation dossier. The Swissmedic authorisation includes a decision on the shelf-life (EXP: ‘The medicinal product may only be used up to the date marked “EXP” on the container’). After the product has been authorised, its shelf-life may be shortened or extended depending on the results of continuing stability studies. This is done either by the pharmaceutical company applying to Swissmedic or Swissmedic ordering the change to be made.

Internationally valid standards

The shelf-life is defined by the international requirements of the ICH (International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and the WHO, not on a country-by-country basis but for entire climatic zones (ICH: climatic zones in the EU, USA and Japan; WHO: allocation of countries to four climatic zones). Switzerland is situated within the European climatic zone and is optimally covered by the ICH and WHO guidelines.

Short shelf-life offers no advantage

Misuse as a result of deliberately short shelf-lives is not in the pharmaceutical industry’s interests. A short shelf-life would have a negative impact on the export, in particular, of a medicinal product. Short shelf-lives can create major logistical challenges or problems in distribution. Shelf-lives that are as long as possible enable more flexible logistics in production and distribution since larger quantities can be manufactured cost-effectively for warehousing. This also reduces the economic risk of having to destroy stored medicinal products because their shelf-life has expired.

Patient safety has priority

Correctly documented shelf-lives determined in compliance with internationally valid guidelines ensure quality and thus patient safety. During the shelf-life of a product, liability remains with the manufacturer (provided the product has been stored and used correctly).