Germany

Germany: Reimbursement of Digital Health Apps – A “World First”

Eda Zhuleku

The Digital Healthcare Act (Digitale-Versorgung-Gesetz DVG) was published in the German Federal Law Gazette (Bundesgesetzblatt) on 18 December 2019 and entered into force on 19 December 2019, having been passed by the German Parliament (Bundestag) in November 2019. Among other regulations intended to expand the digitalisation of the healthcare system, the law will allow the Read More

German courts confirm sales bans on CBD containing food

Eda Zhuleku

According to the latest version of the EU Novel Food Catalogue, EU regulators consider that CBD-containing foods and dietary supplements are classified as novel foods. The Novel Foods Regulation (EU) 2015/2283 defines as “novel” any food which has not been used for “human consumption” to a significant degree within the EU before May 1997. As Read More

Germany Improves Patients’ Access to Medical Cannabis

Eda Zhuleku

The new Law for More Safety in the Supply of Pharmaceuticals in Germany (Gesetz für mehr Sicherheit in der Arzneimittelversorgung- GSAV) which has been in force since 16 August amends the law regarding the prescription and sale of medical cannabis in Germany. Since 10 March 2017, it has been possible for medical cannabis to be prescribed Read More

New German Appointment Service and Supply Act: Implications for investors in the dental industry

Eda Zhuleku

On 14 March 2019, the German Parliament (Bundestag) adopted the German Appointment Service and Supply Act (Terminservice- und Versorgungsgesetz; TSVG), which will come into force in May 2019, as the German Federal Council (Bundesrat) did not veto the law. During the legislative process, it was feared that the Act would have significant impact on the Read More

New legislative proposals in Germany to encourage the use of biosimilars

Eda Zhuleku

The German Federal Ministry of Health recently released draft legislation on the safety of medicinal products – “Gesetz für mehr Sicherheit in der Arzneimittelversorgung” – GSAV In the wake of several recent safety issues, for example,  the release of contaminated pharmaceuticals with potentially carcinogenic substances in 2018, the government aims to improve the safety of medicines by stricter Read More