Life Sciences - Regulation

Recent Articles

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  26/06/2025

  Hungary

  Hungary to implement new laws on registration and termination procedures of legal entities in 2027

  On 1 January 2027, Hungary will replace the current laws regulating the registration, supervision and termination of legal entities with new legislation. These new laws will streamline and centralise the registration and oversight of legal entities, introducing new procedures and mechanisms to ensure their increased level of compliance.Hungary’s parliament has just adopted two acts implementing these systematic changes, the most important elements of which are the following:Unified registration system: the registration of all legal entities (i.e. all types of business associations, the Hungarian...

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  25/06/2025

  Hungary

  Hungary amends FDI regime by adjusting deadlines and extending the scope of preemption rights

  The amendment extends the deadline provided to the Hungarian minister of domestic economy for the examination of transactions falling within the scope of the FDI Decree from 30 business days to 45 business days starting from the date of notification. This deadline may be further prolonged three times by 30 business days if the minister deems it necessary for the clarification of the transaction’s facts ahead of its decision on acknowledgement or prohibition of the transaction.In addition, if the minister prohibits a notified transaction, Hungary can exercise the right of pre-emption over...

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  24/06/2025

  United Kingdom

  New post-market medical device surveillance regulations take effect in Great Britain

  Medical device manufacturers with products on the market in Great Britain now need to actively track and assess the safety and performance of their products after they have been released to the market. The Medicines and Healthcare products Regulatory Agency’s (MHRA) has confirmed that new Post-Market Surveillance Regulations (PMS Regulations) are now in force following a six-month implementation period.The PMS Regulations took effect on 16 June 2025, and apply to medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices. The PMS Regulations apply...

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  23/06/2025

  Ukraine

  Ukraine expands funding for MEAs to enhance patient access to innovative therapies

  On 18 June, the Ukrainian parliament adopted Draft Law # 13135, which includes amendments that empower the Medical Procurement of Ukraine (MPU) with diversified funding sources for Managed Entry Agreements (MEAs). These changes secure broader patient access to innovative medicines by pooling state, regional, municipal and public-hospital budgets while formally embedding the Health Technology Assessment (HTA) into primary law.Additionally, after rigorous parliamentary debates, the Tax Code amendments (Draft Law # 13134) introducing corporate and personal tax exemptions for in-kind transfers of innovative...

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  23/06/2025

  EU, China

  Commission has restricted China’s access to the EU’s public procurement market for medical devices

  On 20 June 2025, the European Commission (the "Commission") announced its decision to exclude Chinese companies from EU public procurements of medical devices exceeding 5 million euros (net of VAT), with certain exceptions (as further detailed below). This decision follows the conclusions of the first investigation under the International Procurement Instrument (“IPI”).The Commissioner for Trade and Economic Security said in the Commission’s press release on the decision “Our aim with these measures is to level the playing field for EU businesses.  We remain committed...

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  19/06/2025

  Ukraine

  Ukraine extends Bolar provision paving the way for faster access for generics

  Section 1: Extension of Bolar ProvisionOn 5 June 2025, the Law on Amendments to Certain Laws of Ukraine Regarding the Implementation of the Bolar Provision, which the Ukrainian parliament adopted in May came into force.The Bolar provision is defined as legislative norms enabling faster access to the market for generic pharmaceuticals and biosimilars by allowing manufacturers to conduct R&D using the original patented medicines and apply for marketing authorisation of their generic alternatives or biosimilars before the expiry of the patents protecting the original reference medicine. This means...

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