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NEWS
The European Parliament’s Internal Market and Consumer Protection Committee (IMCO) has adopted proposals aimed at simplifying and digitalising EU product compliance rules, while retaining paper-based requirements where necessary. The measures promote a ‘digital by default’ approach to product documentation, including EU declarations of conformity (DoC), instructions and contact details. Paper formats will continue to be required in specific cases, in particular for safety-related information. Manufacturers will also be required to ensure that consumers, including people with disabilities, elderly people and those without regular digital access, can request paper information through accessible means, including by phone. The proposals also provide for mandatory electronic exchanges between economic operators and competent authorities.
NEWS
The European Parliament's Internal Market and Civil Liberties Committees have endorsed a provisional agreement on the result of negotiations with the EU Member States on the EU Artificial Intelligence Act (EU AI Act), with a 71-8 vote. The provisional agreement will ensure democracy and the rule of law are promoted and protect fundamental rights by putting obligations on AI based on their potential risks and effects. Oliver Süme, Partner of Fieldfisher LLP, Hamburg and Tom Whittaker, Senior Associate of Burges Salmon provide commentary on the vote.
NEWS
The European Payments Council (EPC) has issued a call for interest, inviting organisations to express their interest in providing services as routing and/or verification mechanisms (RVM) that comply with the verification of payee (VOP) scheme. The EPC developed the VOP scheme to help payment service providers (PSPs) in the European Union (EU) and the European Economic Area (EEA) comply with new regulatory requirements for payee verification, which will take effect on 5 October 2025. Responses are sought by 20 December 2024.
GLOSSARY
Directive 2003/41/EC of the European Parliament and of the Council of the European Union of 3 June 2003 on the activities and supervision of institutions for occupational retirement provision (also known as the IORP Directive).
NEWS
The European Pharmacopoeia Commission (EPC) adopted a new general chapter on cell-based preparations for human use during its March 2025 session. The chapter provides a framework for production and quality control of cell-based preparations, including specific requirements for four types of human cells. While not legally binding, it establishes standardised requirements across Europe. The chapter will be published in European Pharmacopoeia Issue 12.2 in October 2025 and comes into force on 1 April 2026.
NEWS
The European Pharmacopoeia Commission (EPC) has formally endorsed the conclusion of the pilot phase on monoclonal antibodies (mAbs), a type of complex biotherapeutics used to treat conditions like cancer and autoimmune diseases. Since 2014, the goal was to see if it was possible to create official quality standards for these complex medicines. As a result, the EPC and its expert working group developed detailed guidance for two specific mAbs (infliximab and adalimumab), along with general testing methods that apply to many similar medicines. These standards help ensure that mAbs made by different companies are consistently safe and effective. The project involved close cooperation with regulatory authorities, pharmaceutical companies, and academia, using a flexible and science-driven approach.
GLOSSARY
The European Securities & Markets Authority (ESMA) is an independent EU Authority which works to enhance investor protection and promotes stable financial markets. ESMA's responsibilities include assessing risks to investors and markets stability, completing a single rulebook for EU markets and directly supervising credit rating agencies and trade repositories.
GLOSSARY
ESMA is a regulatory agency composed of representatives of the competent national regulatory authorities of the Member States.
GLOSSARY
A network of internationally important sites designated for their ecological status, comprising Sites of Community Importance (SCI), Special Protection Areas (SPAs), Special Areas of Conservation (SACs), candidate Special Areas of Conservation (cSACs), candidate Special Protection Areas (pSPAs) and European Offshore Marine Sites (EOMS). For the purposes of this glossary this term also includes Ramsar sites and potential SPAs.
GLOSSARY
The European Social Fund (ESF) is the EU's financial instrument to support projects in the field of employment. It finances programmes to help EU citizens get better and fairer jobs.
GLOSSARY
The European Standardisation Organisations are officially recognised by Regulation (EU) No 1025/2012 as providers of European standards. European standards are developed through one of the three European Standards Organisations: the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC), and the European Telecommunications Standards Institute (ETSI).
GLOSSARY
The European Supervisory Authorities are regulatory agencies established under the European System of Financial Supervision in order to ensure financial stability.