The European Commission launched a public consultation on 1 March 2022 inviting all interested parties to comment on two drafts revised Horizontal Block Exemption Regulations on Research & Development and Specialisation agreements and the draft revised Horizontal Guidelines.
Baker McKenzie’s Sanctions Blog published the alert titled “Russia imposes a ban on foreign aircraft flights from 36 states” on 1 March 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Hungary has amended laws on clinical trials to adjust them to CTR requirements. In addition, new provisions have been adopted to regulate non-commercial trials, patient recruitment and patient cards.
In March 2021, the EU approved new reporting rules in a directive known as DAC7. The directive will require the operators of online platforms for the sale of goods and certain services, to collect, verify and share data on their sellers and their transactions concluded on the online platform. EU member states have until 31 December 2022 to implement DAC7 into national law. Certain platform operators will become a reporting platform and will need to start collecting and verifying data points in compliance with the DAC7 reporting requirements. The collected data points must be reported to the tax authorities of the relevant EU member state annually.
The National Institute of Pharmacy and Nutrition (“OGYÉI”) issued a Guidance on 20 September which contains useful information on the OGYÉI’s interpretation of the recent legislative amendments of Act XCVIII of 2006 concerning medicine promotion, events and contracts with HCPs.
Recent amendments of Act XCVIII of 2006 („Medicine Economy Act”) have significant impact on medicine and device promotion, interactions with healthcare professionals as well as the pricing and reimbursement of medicinal products. The amendments blur the distinction between promotional and professional/scientific activities and communication which will require assessment of the types of events organized and HCP engagements concluded by pharma companies.
Recent amendments of Act XCVIII of 2006 („Medicine Economy Act”) have significant impact on medicine and device promotion, interactions with healthcare professionals as well as the pricing and reimbursement of medicinal products.
In brief The National Institute of Pharmacy and Nutrition (“OGYÉI”) has issued new decisions on its webpage concerning…
In brief On October 14, 2020 the Hungarian Parliament adopted Act C of 2020 on Healthcare Service Relationship…
The pandemic has impacted our lives in many ways, but for many of us, one of the most affected areas has certainly been work. COVID-19 has indeed led to an unprecedented need and demand for remote working. In recent months, many people have been forced or have chosen to work…