Implementing regulations in the therapeutic products area: Start of consultation procedure for Federal Council and Agency Council Ordinances

As a result of numerous amendments to the revised Therapeutic Products Act, the relevant ordinances (Therapeutic Products Ordinance Package IV) also need to be comprehensively amended. The consultation procedure on the corresponding ordinances of the Federal Council and the Swiss Agency for Therapeutic Products, Swissmedic will last until 20 October 2017. These amendments affect ordinances issued both by the Federal Council and the Agency Council of Swissmedic.

The National Council and the Council of States approved the revised Therapeutic Products Act on 18 March 2016. Individual provisions (national recommendations on off-label dosages of paediatric medicinal products, or definitive arrangements for medicinal products approved by cantons) and the corresponding ordinance terms will enter into force ahead of schedule at the beginning of 2018. The Federal Council is conducting a consultation procedure for most of the implementing provisions (Therapeutic Products Ordinance Package IV), which are scheduled to apply from 2019.

The primary objectives of the revision of the Therapeutic Products Act (2nd stage), with the proposed amendments in implementing regulations are as follows:

Facilitate market access, provide simpler access to medicines

The authorisation of certain medicinal product categories (especially medicinal products approved in an EU or EFTA country, medicinal products with traditional uses, and medicinal products already approved in a canton, as well as various medicinal products used in complementary medicine) is to be simplified. At the same time, self-medication is to be made easier, making better use of the expertise at dispensing outlets for medicinal products (drugstores, pharmacies).

Improve drug safety

In order to enhance drug safety, the legal bases for market surveillance will be adapted to international developments (introduction of a Pharmacovigilance Plan, application of Good Vigilance Practice, extension and more detailed explanation of the scope of reporting obligations) and minimum requirements will be defined for the prescribing of medicinal products.

Promote medicines for children

In order to improve the provision of safe paediatric medicines, the safety of medication in paediatrics will be increased and an incentive system introduced for the pharmaceutical industry (publication of a list of off-label dosage recommendations for medicinal products used in paediatrics, creation of new obligations and incentives for the pharmaceutical industry to promote the development of paediatric medicines).

Increase transparency

In numerous areas the Swiss Parliament and Federal Council want to increase transparency, for example by allowing Swissmedic to publish additional information on medicinal products submitted to it for assessment and their marketing authorisation holders, or by amending the regulations on pecuniary benefits.


Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for the control of therapeutic products throughout Switzerland and, as the authority for implementing the Therapeutic Products Act at federal level, is responsible for the ordinances issued by the Agency Council.

The Ordinary Revision of the Therapeutic Products Act (Stage 2) is part of the Confederation's master plan for strengthening biomedical research and technology.

Address for enquiries
Swissmedic, Swiss Agency for Therapeutic Products
+41 58 462 02 76
media@swissmedic.ch

Supplementary information
FOPH Media Release 

Documents on the consultation procedure
FOPH, Legislative Projects Therapeutic Products Ordinance Package IV  

Last modification 21.09.2018

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