The following Life Sciences practice note provides comprehensive and up to date legal information covering:
This Practice Note deals with key issues that are likely to affect the life sciences sector as a result of the UK’s withdrawal from the EU. It briefly considers the relevance of EU law and the Withdrawal Agreement to the sector and the respective roles of the EU and UK regulators. It outlines the impact of the Withdrawal Agreement on marketing authorisations (MAs) and medicinal products regulatory framework, medical devices, clinical trials, research and development, data protection, and import-export.
The life sciences sector is one of the most highly regulated and globally harmonised industry sectors. A large amount of the regulation originates from the EU in the form of directives or regulations and is supplemented by guidance issued by the European Commission and the European Medicines Agency (EMA), the decentralised agency of the EU responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
The Withdrawal Agreement, which was approved by the UK Parliament by way of the European Union (Withdrawal Agreement) Act 2020 (EU(WA)A 2020), includes provisions for a transitional period (known in the UK as the implementation period) which is set to last until 31 December 2020. During the transition period, the UK maintains access to the UK single market and customs union and is bound by EU law as if it were a Member
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On 29 August 2015, the Prudential Regulation Authority (PRA) published the PRA Rulebook (Rulebook). The transition from the Handbook to the Rulebook was intended to benefit PRA-authorised firms, to access clearer and more concise rules. Alongside the Rulebook, supervisory statements and statements
What is quia timet relief?Injunctions are generally awarded where a party has already suffered a wrong. For guidance on injunctions generally, see Practice Note: Injunctions—guiding principles. However, an injunction may be sought before a party's rights have been infringed on the basis that they
This Practice Note provides guidance on the interpretation and application of the relevant provisions of the CPR. Depending on the court in which your matter is proceeding, you may also need to be mindful of additional provisions—see further below.Note: this Practice Note does not deal with the
What is recklessness?In respect of some statutory offences and common law crimes the prosecution are required to prove a mental element of recklessness on the part of the defendant.Recklessness means unjustified risk taking on the part of the accused.Prior to the House of Lords decision in Re G
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