Medicrime Convention - legislative changes and implementing provisions

Legislative changes in connection with the implementation of the Medicrime Convention and the provisions of the revised MPLO have applied since 1 January 2019. Article 17a of the TPA will come into force at a later date.  

In November 2018, the Federal Council decided to enact per 1 January 2019 the amendments to the Swiss Criminal Procedure Code and to the Therapeutic Products Act (TPA) relating to the implementation of the Medicrime Convention - with the exception of the new Article 17a of the TPA, concerning the voluntary placing of safety features to medicinal product packaging.
On 1 January 2019, part of the implementing legislation also came into force, namely the fully revised Medical Products Licensing Ordinance (MPLO).
These changes to the law give Switzerland the instruments necessary to boost the fight against counterfeit medicines, and increase the safety of medicines in our country.

Implementing provisions: total revision of the MPLO

The MPLO aims to ensure that only high-quality, safe and effective medicines are manufactured and placed on the market in Switzerland, in accordance with the principles of appropriate quality assurance and in compliance with the TPA.
The total revision project entails certain amendments ensuing from the ordinary revision of the TPA (Stage 2), as well as certain adaptations resulting from new knowledge gained in practice.
The approved amendments improve medicine control and traceability in the distribution chain. This particularly affects intermediaries, who now assume greater responsibility in the drugs market. The new MPLO also facilitates the supply of medicines, particularly of vaccines, enabling doctors to obtain them by a more direct route and at lower cost. Furthermore, drugstores are now allowed to import small quantities of medicines and it is possible to administer experimental medicines for a limited period in carefully defined cases.

Implementing provisions - Article 17a TPA

In its ongoing efforts to protect patients against counterfeit medicines, and in addition to the legislative changes related to the ratification of the Medicrime Convention, in 2017 the Federal Parliament made provision in the TPA (new Article 17a) for safety features to be placed on medicinal product packaging (analogous to the features provided for by EU Directive 2011/62/EU “Falsified Medicines Directive”, FMD).
Switzerland intends to make it optional to add and verify safety features – unlike the European Union (EU), where it is mandatory. The delegated regulation that specifies the implementation details of the FMD entered into force in the EU on 9 February 2019; Switzerland is not bound by this date.
The implementing provisions relating to the new Art. 17a TPA are being drawn up. The consultation procedure for the new ordinance has been opened on 22 October 2019 and will last until 5 February 2020. The draft ordinance and all associated documents can be accessed under Links.

Legislation

Medicinal products and medical devices legislation

The legislation on therapeutic products comprises the Federal Act on Medicinal Products and Medical Devices (TPA) and the associated ordinances. It is regularly aligned to the state of scientific and technical knowledge.

Last modification 06.11.2019

Top of page

Contact

Federal Office of Public Health FOPH
Division of Biomedicine
Therapeutic Products Law Section
Schwarzenburgstrasse 157
3003 Berne
Switzerland
Tel. +41 58 463 51 54
E-mail

Print contact

https://www.bag.admin.ch/content/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/ratifizierung-medicrime-konvention.html