SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang and Djamila Batache, Bär & Karrer Ltd
tiveness, safety concerns, or the absence of an established standard treatment (see Section 14.2 of Swissmedic guidance document “Fast-Track Authorisation Procedure”). • The new medicinal product must offer a signifi- cant improvement based on new clinical evidence. To provide a comparative basis, applicants must evaluate efficacy and safety data against existing authorised medicinal products available in Swit- zerland (see Section 14.2 of Swissmedic guidance document “Fast-Track Authorisation Procedure”). Medical Devices For medical devices, Switzerland currently does not explicitly provide a fast track registration route, mean- ing there is no expedited conformity assessment pro- cedure. However, in exceptional cases, Swissmedic may – upon a duly justified request – authorise the placing on the market and use of a specific medical device in the interest of public health or patient safety, even if the full conformity assessment has not been completed (eg, because the device has not under- gone a complete conformity assessment procedure or the certificate for a device for the device has been declared invalid) or the language requirements are not met (Article 22 paragraph 1 of the MedDO and Article 18 paragraph 1 of the IvDO). Article 22 paragraph 2 of the MedDO and Article 18 paragraph 2 of the IvDO permit the placing on the market and use of individual devices without valid certificates in an individual case if the following con- ditions are fulfilled: • the device serves to avert life-threatening condi- tions or to prevent the permanent impairment of a bodily function or, in the case of in vitro diagnostic medical devices, is used to test samples with the aim of averting or treating life-threatening condi- tions or permanent impairments of a body function; • no conforming device is available for this specific intended purpose; • the device is used exclusively by HCPs either directly on an individual patient or in a laboratory setting for patient-specific sample testing; • the HCP using the device or providing treatment has informed the patient about the non-conformity of the device and the associated risks; and
• the patient concerned has provided consent for the use of the device. The decision to use a non-conforming device must be based on a thorough risk–benefit assessment for the specific case. A Swissmedic authorisation is not required for these cases (see Swissmedic information sheet “Derogation MEP”). However, the exemption is limited to the manufacturer or importer making the device available to the user for the first time. Devices authorised under these exceptional provisions must not be traded or made widely available on the market. To ensure compliance with Article 22 paragraph 2 of the MedDO and Article 18 paragraph of the IvDO, the responsible HCP must document compliance with the specified conditions and retain all relevant records for regulatory verification. 4.2 Regulatory Reliance Medicinal Products Swissmedic may expedite the approval process for certain medicinal products if they have already been authorised by internationally recognised regulatory bodies, such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), or others. Applicants seeking authorisation, an extension, or a variation for a medicinal product or procedure that has already been approved in a country with a compara- ble regulatory system may benefit from Swissmedic’s reliance on foreign assessment results (Article 13 of the TPA) – provided the following conditions are met. • The submitted foreign authorisation documents, including all variations, must be no older than five years and reflect the product’s current approval status abroad (Article 16 paragraph 1 lit a of the OMP). Minor deviations from the foreign submis- sion are permissible if they are justified (Article 16 paragraph 2 of the OMP). Such differences may, in particular, concern a different name for the medici- nal product, a different pack size, or a different secondary packaging. • The full and final assessment reports from the foreign regulatory agency must be available (Article 16 paragraph 1 lit b of the OMP).
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