Good Distribution Practice of Medicinal Products

The Federal Department of Home Affairs has adapted the Guidelines on Good Distribution Practice of Medicinal Products according to EU law. This move increases quality requirements for the distribution of medicinal products and strengthens patient protection.

Background and content of the GDP Guidelines

In 2011 the European Union (EU) enacted a new directive named “Falsified Medicines Directive” (Directive 2011/62/EU) with the aim of preventing counterfeit medicines from entering the legal supply chain. The Guidelines on Good Distribution Practice of Medicinal Products for Human Use (GDP Guidelines, 94/C 63/03 of 1 March 1994) were subsequently revised. The amended Guidelines (2013/C 343/01) came into force in the EU in September 2013. They aim to ensure the quality of all activities connected with the distribution of medicinal products (storage and transport conditions, etc.). However, some of the requirements specified in these new guidelines are stricter than before (as regards, for example, transport, outsourced activities, IT systems, etc.).

Revision of the Medicinal Products Licensing Ordinance

The GDP guidelines are part of the bilateral agreements between Switzerland and the EU (SR 946.526.81). By amending Appendix 2 of the Medicinal Products Licensing Ordinance (MPLO), Switzerland adopts the new guidelines and aligns its provisions with the stricter EU requirements. The equivalent requirements for the distribution of medicinal products aim to avoid trade obstacles for the Swiss exporting industry, while at the same strengthening patient protection. The revisions came into force on 1 July 2015, with a six-month implementation period until 1 January 2016.

Analysis report GDP, corrected (in German) (PDF, 510 kB, 15.08.2018)

Korrigendum Analysis report (in German) (PDF, 136 kB, 15.08.2018)

GDP Guidelines (2013/C 343/01), 05.11.13

Falsified Medicines Directive (2011/62/EU), 08.06.11

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CC 812.212.1 Verordnung über die Bewilligungen im Arzneimittelbereich (in German, French and Italian)

CC 946.526.81 Abkommen zwischen der Schweizerischen Eidgenossenschaft und der Europäischen Gemeinschaft über die gegenseitige Anerkennung von Konformitätsbewertungen (in German, French an Italian)