Total revision of MPLO and Falsified Medicines Directive

Legislative changes in connection with the implementation of the Medicrime Convention and the provisions of the revised Ordinance on Licensing in the Medicinal Products Sector (MPLO) entered into force on 1 January 2019. This will improve the safety of medicinal products.

At its 14 November 2018 meeting, the Federal Council set 1 January 2019 as the date on which the adjustments to the Swiss Criminal Procedure Code (CrimPC) and the Therapeutic Products Act (TPA) relating to the implementation of the Medicrime Convention enter into force, with the exception of the new Article 17a of the TPA concerning the voluntary placing of safety features to medicinal product packaging.
The Federal Council also decided that part of the implementing regulations, i.e. the total revision of the Ordinance on Licensing in the Medicinal Products Sector (MPLO), would enter into force on the same date.
The legislative amendments equip Switzerland with the tools necessary to step up the fight against counterfeit medicines, and help enhance the safety of medicines in Switzerland.

Implementing regulations: 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.
Among other things, the approved modifications will improve medicine control and traceability in the distribution chain. This will particularly affect intermediaries, who will assume greater responsibility in the medicines market. Under the new MPLO, it will also be possible to improve the supply of medicines, particularly vaccines, which doctors will be able to obtain by a more direct route and at lower cost. Furthermore, drugstores will be able to import small quantities of medicines. Finally, it will be possible to administer experimental medicines for a limited period in carefully defined cases.

Implementing regulations: European “Falsified Medicines Directive”

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, on 29 September 2017 the Federal Parliament made provision in the TPA (new Article 17a) for safety features to be added to medicinal product packaging (analogous to the features provided for by EU Directive 2011/62/EU “Falsified Medicines Directive”, FMD).
These safety features fall into two categories. The first makes it possible to verify that medicines are authentic and to identify individual boxes (unique identifier), the second to detect whether packages have been opened (anti-tampering device). This is a preventive measure intended to prevent counterfeit medicines from entering the legal supply chain.
Switzerland intends to make it optional to add and verify safety features – unlike the European Union (EU), where it is mandatory. 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 is scheduled to take place in the second half of 2019.

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 10.05.2019

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