Medicinal products formerly in dispensing category C, which was discontinued as of 1 January 2019, are officially being reallocated to categories D or B. Each month, Swissmedic publishes a list of the medicinal products reallocated from C to B for which the new classification has taken legal effect.
Revision of therapeutic products legislation: list of medicinal products reallocated from dispensing category C to dispensing category B
As part of the revision of the Therapeutic Products Act, the government decided to abolish dispensing category C. Authorised medicinal products which were in this dispensing category until 31 December 2018 are required by law to be reallocated to either category D or category B.
Medicinal products which, for reasons of medical safety, require consultation with a healthcare professional (doctor or pharmacist) are being reallocated to dispensing category B. In accordance with Art. 45 para. 1 let. c of the Therapeutic Products Ordinance (TPO; SR 812.212.21), however, these medicinal products can still be obtained at pharmacies without a doctor's prescription, but only after a personal consultation with a healthcare professional.
Each month as of June 2019, Swissmedic publishes a list of the medicinal products which, in accordance with Art. 45 para. 3 of the Therapeutic Products Ordinance have been reallocated from C to B and for which the new classification has taken legal effect.
Where a medicinal product is allocated to dispensing category B, Swissmedic may only publish the reallocation decisions in the Swissmedic Journal after the decisions have entered legal force and, in particular, must wait until the 30-day period for objections has elapsed. Once these reallocations have been published in the Swissmedic Journal, the stipulations of the revised therapeutic products legislation are applicable.
Authorisation holders of co-marketing medicinal products are required to implement the decisions relating to the basic authorisation.
Co-marketing medicinal products
In terms of therapeutic products legislation, co-marketing medicinal products are directly subject to the rules applicable to the basic product, and are thus not being reclassified by Swissmedic. The authorisation holder of a co-marketing medicinal product is required by law to adopt all changes to a basic product for the co-marketing medicinal product (cf. Art. 38, para. 2 of the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Therapeutic Products and the Licensing of Therapeutic Products by the Notification Procedure [TPLO, SR 812.212.23]).