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Healthcare & Life Sciences

28 April 2021
Rainer Herzig Court dismisses complaint against limitations on sale of medicinal products

Austria - Preslmayr Attorneys at Law

The Act on Medicinal Products and the Trade and Industry Act set strict rules on the sale of medicinal products. The German-Austrian drugstore chain, dm, brought a constitutional complaint against these limitations. In a decision which is likely to disappoint those in favour of market liberalisation, the Constitutional Court recently dismissed the complaint.

Author: Rainer Herzig
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Fabian Huber COVID-19 pandemic: relief for vaccination damage provided by law

Germany - Simmons & Simmons LLP

Vaccinations represent a ray of hope in the fight against the COVID-19 pandemic. However, in recent months there have been several incident reports regarding vaccinations. These primarily concern cerebral venous thrombosis, which in some cases has caused serious health damage to patients or even death. Against this background, the question arises as to how the law responds to damage to patients caused by vaccinations.

Authors: Fabian Huber, Caroline von Nussbaum
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Joanne van Harmelen Biosimilar regulation FAQs

South Africa - ENSafrica

A biosimilar is a biological medicine that is manufactured to be similar, but – unlike a generic pharmaceutical medicine – not necessarily identical, to its reference medicine. The South African Health Product Regulatory Authority has published several guidelines to assist applicants which wish to register biological and biosimilar medicines. This article answers FAQs about the registration of biosimilar medicines in South Africa.

Author: Joanne van Harmelen
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Sarah Taylor SPCs post-Brexit: where are we now?

United Kingdom - Pinsent Masons

Changes to the processes for obtaining marketing authorisations for medicinal products are one of the many differences brought about as a result of the United Kingdom's departure from the European Union. However, behind the high-profile headlines is the knock-on effect that these changes will have on the regime which governs supplementary protection certificates (SPCs) in the United Kingdom. This article considers the changes to the SPC regime and the SPC manufacturing waiver in the United Kingdom.

Authors: Sarah Taylor, Charlie Davies
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