The European Medicines Agency (EMA) has updated guidance on good manufacturing and distribution practices (GMP/GDP), adding questions and answers on the basic requirements for active substances used as starting materials. EMA added two questions about third-party audit reports clarifying that manufacturers may contract with third parties to undertake relevant audits. Ultimately, it explained that the Qualified Person is responsible for ensuring audit reports are properly evaluated when the audit is performed by a third party'. The written final assessment text should provide a 'comprehensible summary' of the evaluation. EMA said assessments should include 'all expected elements of the auditing process and audit report(s) identified before, during, and after the audit'. 'This includes verification of contractual arrangements, scope and appropriate duration of audit, adequate competence of auditors considering the scope of the audit, planned audit frequency, and CAPAs whether adequate and how these are to be followed up' the Q&A states. also, any conflicts of interest identified should be discussed.​

Construction analysis: In the recent case of Severfield (UK) Ltd v Duro Felguera UK Ltd, the Technology and Construction Court (TCC) refused a summary judgment application. It held that, in a contract that included both construction operations under section 105 of the Housing Grants, Construction and Regeneration Act 1996 (HGCRA 1996) and excluded operations, the claimant could not subsequently alter the amount it had claimed in its original payment notice to make a new claim under HGCRA 1996—it could not therefore rely on the previous lack of a pay less notice when the new sum claimed for construction operations was not identified in the original payment application. The court also reiterated the importance of clear and unambiguous payment notices following recent TCC authorities.

The Crown Commercial Service (CCS) has announced a collaborative effort with the Department for Transport (DfT) and the Local electric vehicle infrastructure fund (LEVI) support body to streamline the procurement process for public electric vehicle (EV) infrastructure. This initiative has resulted in the creation of draft configurable templates designed to facilitate the deployment of public EV infrastructure through a concession contract approach. The templates aim to significantly reduce the time, cost, and resources required for public bodies to procure such infrastructure. While these documents are provided as guidance, the CCS emphasises that independent legal and professional advice should be sought before use, and explicitly disclaims any liability arising from the utilisation of these resources.

This document provides general guidance regarding the protection of home rights. Your family lawyer will be able to provide specific advice based on your circumstances. Home rights During the course of a marriage or civil partnership where one of you is entitled to occupy a property, if your name is not registered on the title to the property at HM Land Registry (HMLR), you are entitled to register home rights (formerly known as matrimonial home rights) at HMLR as a charge against the property. The provisions regarding home rights are set out in the Family Law Act 1996 (FLA 1996). Home rights permit occupation of the property, they do not give any right of ownership of any kind in the family home, nor do they act to exclude anyone else from the property—they are rights personal to you not to be evicted or excluded without leave of the court, and the right, with leave of the court, to enter and occupy the property if you are not already in occupation of the home. Your family

Arbitration analysis: In November 2024, the Court of Appeals of the State of São Paulo (TJSP) ruled that it lacks jurisdiction to hear an annulment action seeking to set aside a partial arbitral award rendered in New York, even though the parties had agreed, in the underlying contract, that any such actions would be filed before São Paulo state courts. Relying on the premise that, under Brazilian law, foreign arbitral awards (ie, awards rendered outside of Brazil) can only be enforced in the country after being recognised by the Brazilian Superior Court of Justice (Brazil’s highest court for non-constitutional matters—STJ), the TJSP held that the judicial review of those foreign awards can only occur within the scope of those recognition proceedings. Moreover,contracting parties cannot alter this jurisdictional structure or otherwise transfer this jurisdiction to Brazilian lower courts through forum selection clauses. Written by Renato Stephan Grion, partner at Pinheiro Neto Advogados, and Guilherme Piccardi, senior associate at Pinheiro Neto Advogados.

Arbitration analysis: This case involved an application to Commercial Court of the City of St Petersburg and Leningrad Region (the ‘Russian Court’) to prohibit continuation of legal proceedings in a foreign court and in the international arbitration, seated outside RF. The claimant, a Russian company, commenced proceedings in the Russian Court against the respondent, a German bank, for breach of contract, despite the existence of the valid ICC arbitration agreement between the parties. The respondent, who commenced an ICC arbitration against the claimant, obtained an anti-suit injunction from the English court. However, the Russian Court proceeded to uphold the claimant’s claim, and, furthermore, awarded the claimant its application for an anti-suit injunction against the respondent, as well as ordered the respondent to pay punitive damages to the claimant in the event of non-compliance with the Russian Court’s order. Written by Irina Tymczyszyn FCIArb, arbitrator and counsel, Tymczyszyn Arbitration.

Arbitration analysis: The case at hand provides useful clarification regarding the coordination between the arbitration clause and the mediation clause in cases where the contract makes it explicit that arbitration is subjected to prior mediation. The Cour de cassation rule that the requirement of initiation of the mediation before arbitration is not a matter of jurisdiction of the arbitral tribunal but of admissibility of the claim presented to it. Therefore, non-compliance with the preliminary mediation clause does not justify the setting aside of the arbitral award under Article 1492, 1° of the French Code of Civil Procedure (the ‘CCP’), which allows a party to apply to annul a domestic arbitral award before French courts on the ground that the arbitral tribunal wrongfully upheld or declined its jurisdiction. Written by William Kirtley, partner, and Zuzana Vysudilova, senior associate at Aceris Law LLC.

Arbitration analysis: The Supreme Court of Victoria held that, on an application to appoint an arbitrator under s 11(3)(b) of the Commercial Arbitration Act 2011 (Vic), the court need only be satisfied on a prima facie basis that an arbitration agreement exists. Contested questions concerning formation or validity should ordinarily be determined by the tribunal under the Kompetenz-Kompetenz and separability principles, rather than through jurisdictional mini-trial at the appointment stage. Practitioners resisting appointment should therefore distinguish challenges directed specifically to the arbitration agreement from those concerning the substantive contract and plan any jurisdictional challenge under s 16, while ensuring legacy arbitration clauses contain effective appointment machinery. Produced in partnership with Cameron Ford SC of William Forster Chambers.

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: Court specific guidance below. Scope of this Practice Note Civil fraud encompasses a broad range of potential causes of action, at the heart of which are allegations of dishonest conduct. It is an interesting and challenging area of law that English courts and practitioners are used to encountering. The courts are well-equipped to deal with these cases and have jurisdiction to grant a range of remedies that can assist parties to achieve an effective resolution of their disputes. This Practice Note is intended to be a practical guide for lawyers acting on behalf of claimants in civil fraud cases. Since civil fraud encompasses so many different causes and can arise in a multitude of different contexts, this Practice Note is not intended to cover all aspects of law and practice that may be relevant in civil fraud

Defined terms: This Precedent clause uses the additional defined terms ‘Agreement’, ‘Business Day’, ‘Disclosing Party’, ‘parties’, ‘person’ and ‘Receiving Party’, which are not specific to data processing and which it is assumed are separately defined (or will be adapted) as appropriate in the relevant agreement. It is assumed that references to ‘Disclosing Party’ and ‘Receiving Party’ will be conformed as appropriate to reflect the relevant defined term for each party used in the agreement in which this clause is used. 1 Data protection 1.1 In this clause 1: Communication • means a complaint, request or other communication (but excluding any Data Subject Request) relating to either party’s obligations under any Data Protection Laws in connection with this Agreement and/or the processing of any of the Shared Personal Data, including any compensation claim from a Data Subject or any notice, investigation or other action from a Data Protection Supervisory Authority relating to the foregoing (and Communicator means the Data Protection Supervisory Authority, Data Subject or other person initiating or conducting a Communication); Consent • means a freely given, specific, informed and

This Agreement is made on [insert date] Parties 1 [Insert supplier name] a company incorporated in [England and Wales] whose registered company number is [insert company number] and whose registered office is at [registered office address] (Supplier); 2 [Insert customer name] a company incorporated in [England and Wales] whose registered company number is [insert company number] and whose registered office is at [registered office address] (Customer), each of the Customer and Supplier being a party and together the Customer and Supplier are the parties. Background (A) The Customer operates [a website OR certain websites]. (B) The Supplier offers internet marketing and website optimisation services. (C) The Customer agrees to engage the Supplier to provide certain services in relation to the Customer’s website[s], and the Supplier agrees to provide the same, on the terms and conditions of this Agreement and in each Order Form (as defined below) agreed by the parties from time to time under this Agreement. The parties agree: 1 Definitions and interpretation 1.1 In this Agreement: Acceptance Criteria • means the criteria to be satisfied to demonstrate that the Acceptance Tests for the Deliverables have been met, as determined pursuant to Schedule 2; Acceptance

In the judgment of the Court of Appeal in Street v Derbyshire Unemployed Workers’ Centre, which was also referred to by Jackson LJ in Mid Essex Hospital NHS Trust v Compass Group UK and Ireland Ltd, it was held: ‘The words “in good faith” have a core meaning of honesty. Introduce context, and it calls for further elaboration…The term is to be found in many statutory and common-law contexts, and because they are necessarily conditioned by their context, it is dangerous to apply judicial attempts at definition in one context to that of another.’ With respect to commercial transactions, although English courts have traditionally shown hostility towards implying a duty of good faith in this context, the way to approach giving meaning to ‘good faith’ is now reasonably clear. In Mid Essex Hospital Services, Beatson LJ applied an objective test; ‘when given the wording of the contract