Reclassification of medicinal products: status update

Projekt zur Umteilung von Arzneimitteln in andere Abgabekategorien im Rahmen der Heilmittelgesetzrevision


Work on the project to reclassify medicinal products in other dispensing categories is progressing as planned. Following pre-evaluation by Swissmedic specialists, the committee held four full-day meetings with external specialists representing dispensing outlets in the period up to the end of April 2018. The meetings discussed the categorisation of 640 medicinal products currently in dispensing category C as well as some 400 in category D. Discussions on the latter centred on the possibility of dispensing them without expert advice (reclassification from dispensing category D to category E).

Representatives of the Swiss Medical Association FMH, Swiss Pharmacists’ Association Pharmasuisse, Swiss Druggists’ Association SDV, the complementary medicine umbrella organisation Dakomed, the Swiss association for complementary medicinal products SVKH, the Association of the Swiss Self-Medication Industry ASSGP, patient organisations and cantonal pharmacists took part in the expert dialogue. Everyone involved contributed energetically, which resulted in valuable and in some cases controversial discussions, as well as in supplementary written statements. The next meeting of the external specialist committee is scheduled for the end of June 2018 and will focus on developing further work packages involving medicinal products in dispensing category D.

Next steps
In the next few months, Swissmedic will assess and make a decision on the future categorisation (dispensing category D or B) of all medicinal products in dispensing category C. Its decisions will take account of the feedback received from the external expert committee. The lists showing the new dispensing categories are due to be published as preliminary information in November 2018.

The actual reclassification of the medicinal products will take place in early 2019, once the revised Therapeutic Products Act has entered into force and in the course of normal administrative procedures. The industry was given a preliminary briefing on the process during the Regulatory News 2017 information event held last December. The process is currently being fleshed out. Swissmedic will brief the industry at the regulatory roundtables that have already been planned and at the information events on TPO IV and MPLO/Medicrime that it has scheduled for autumn 2018.

New or ongoing applications for authorisation or a change in dispensing category
Swissmedic points out to companies that the criteria defined for reclassifying medicinal products in other dispensing categories also apply to new applications or applications for changes. They also apply to ongoing applications for authorisation of a medicinal product in dispensing category C.

Companies are requested to take account of these criteria and not to submit any new applications for approval of medicinal products in dispensing category C.

As part of the revision of the Therapeutic Products Act, the government has decided to simplify self-medication and make fuller use the specialist competencies of the dispensing outlets (druggists and pharmacies). Dispensing category C is therefore being withdrawn. Swissmedic informed the representatives of the affected professional associations and the designated external specialists about the project to reclassify medicinal products in other dispensing categories and about their intended role in the project on 6 April 2017.