The Federal Council has approved Therapeutic Products Ordinance Package IV (TPO IV). Swissmedic and the FOPH publish the revised documents.
With the ordinary revision of the Therapeutic Products Act, the legislator aims to improve public access to medicines and the general environment for biomedical research and industry. The National Council and Council of States adopted the core elements of the Federal Council's draft, with certain changes, and approved the revised Therapeutic Products Act in the final vote on 18 March 2016.
Because of the numerous legislative amendments, the relevant ordinances also had to be comprehensively amended. Individual provisions (national recommendations on dosages of paediatric medicinal products, definitive arrangements for medicinal products approved by cantons) and the corresponding ordinance terms already entered into force at the beginning of 2018.
Adapted documents and their entry into force
The majority of the revised implementing ordinances (Therapeutic Products Ordinance Package IV; TPO IV) for the ordinary revision of the Therapeutic Products Act (TPA 2) will come into force on 1 January 2019.
TPO IV comprises the ordinances both of the Federal Council and of the Swissmedic Agency Council. The Agency Council approved five ordinances on 7 September 2018. On 21 September 2018, the Federal Council passed resolutions on three additional ordinances.