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Market Access in Europe: Navigating Pricing & Reimbursement Pathways

In Europe, the regulation of pricing and reimbursement for medicinal products is primarily governed by national policies, as EU-level regulation is limited. Our latest brochure “Market Access in Europe: Navigating Pricing &...more

Turnaround of Medical Cannabis in Germany? – Draft bill by new German Government to address alleged missteps

On June 18, 2025, the Federal Ministry of Health (Bundesministerium für Gesundheit - BMG) published a draft bill proposing severe amendments to the German Medical Cannabis Act (Medizinal-Cannabis Gesetz - MedCanG) – just a...more

The coronavirus (self-)test kits for laypersons – an approach in various steps

Step by step towards self-testing: Due to the Covid-19 pandemic, which continues to impinge upon everyday life, the German Federal Ministry of Health (Bundesministerium für Gesundheit, “BMG”), after approving the distribution...more

Gesundheitsministerium bestätigt Zulässigkeit Abgabe von Probenentnahme-Sets für SARS-CoV-2-Labortest an medizinische Laien

Seit Monaten wird die Frage kontrovers diskutiert, ob Probenentnahme-Sets zur Feststellung einer SARS-CoV-2 Infektion oder entsprechender Antikörper an jedermann abgegeben werden dürfen oder nicht....more

German MoH confirms admissibility of supply of kits for SARS-CoV-2 lab tests to medical laypersons

For months now there has been ongoing controversial debate about whether or not specimen-collecting kits for the detection of a SARS-CoV-2 infection or related antibodies may be furnished to members of the general public. ...more

Additional German guidance on the management of clinical trials during the COVID-19 pandemic

Further to the European Guidance on the Management of Clinical Trials during the COVID-19 pandemic, the German higher federal authorities (the Federal Institute for Medicinal Products and Medical Devices (BfArM) and...more

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