Marketing Authorisation meaning

Medicinal products cannot be marketed without prior approval in place. This Flowchart sets out the steps and requirements to obtain approval, referred to as a marketing authorisation (MA), through the EU decentralised route. The decentralised pathway allows marketing authorisations for medicinal products to be granted concurrently across EU Member States in parallel and simultaneously...

This decision tree outlines a logical route for deciding whether you can carry out live telephone marketing and, if permitted, who you may contact. For guidance on other forms of marketing, see: Direct marketing decision tree—postal—data protection and Direct marketing decision tree—email and other electronic mail marketing—data protection. Direct marketing refers to the communication (by any means) of advertising or promotional material directed at specific individuals. Live or automated telephone calls? This decision tree is not intended for automated calls, as the rules governing automated calls are far more stringent than those for live calls. You must not make automated marketing calls to an individual unless they have given explicit consent to receive that precise type of call from you. General marketing consent, or consent applicable only to live calls, is insufficient—it must expressly include automated calls. Consequently, there is little value in a decision tree for automated marketing calls—this tree covers live marketing calls only. See Practice Note: Direct marketing compliance—Automated calls. Claims management services ...

Flowchart No pharmaceutical product can be marketed without prior authorisation. This Flowchart describes the steps to obtain such approval, termed a marketing authorisation (MA), via the EU centralised route as set out by the procedure...

In this issue: Post-market Intellectual property Pharmaceuticals—regulatory framework Research and development Medical devices Daily and weekly news alerts New and updated content Trackers Useful information Post-market What’s next for UK product liability? Andrew Austin, partner; Harriet Hanks, counsel; and Rachel Duffy, senior associate at Freshfields LLP, examine the UK Law Commission’s review of the domestic product liability framework for defective goods, with a particular lens on emerging technologies such as artificial intelligence, and set against notable recent developments in the EU. See News Analysis: What’s next for UK product liability? EMA updates pharmacovigilance requirements and ends EudraVigilance pilot phase The European Medicines Agency (EMA) has released guidance following adoption of Commission Implementing Regulation (EU) 2025/1466, which amends Regulation (EU) No 520/2012. This change formally concludes the EudraVigilance signal detection pilot for Marketing Authorisation Holders (MAHs), and requires all MAHs with authorised medicinal products in the EEA, including Northern Ireland, to monitor EudraVigilance...

In this issue: Intellectual property Medicines advertising Medical devices Data protection in life sciences Pharmaceuticals—regulatory framework Research and development Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Intellectual property Ian Jones, partner at Gill Jennings & Every LLP, reviews upcoming changes to UK marketing authorisations (MAs) and supplementary protection certificates (SPCs) following the UK Intellectual Property Office’s statutory guidance on SPCs for medicines, set to apply from 1 January 2025. On 31 October 2024, the UK IPO issued guidance detailing significant updates to MAs for medicines in the UK, grounded in the Windsor Framework, which will come into force on 1 January 2025. These reforms will influence existing and prospective SPCs, as well as the types of authorisation used to support SPC applications. See News Analysis: Changes to marketing authorisations and SPCs in the UK. The Patents Court has revoked two mRNA patents related...

In this issue: Energy Environment Life sciences TMT LexTalk®EU Law: a Lexis®Nexis community Daily and weekly news alerts Trackers New and updated content Energy Consultations open on FuelEU Maritime verification and monitoring requirements The European Commission has opened three consultations on the FuelEU Maritime Regulation, intended to advance the decarbonisation of the shipping sector. The first examines the technical specifications for verification activities that will apply to shipping companies’ emissions. The second presents a template for the plans that companies must submit, explaining how their ships will be verified and how their emissions will be monitored. The third details the methods and criteria for accrediting ‘verifiers’ who will oversee compliance with the monitoring plan and the verification of FuelEU reports and documentation. The deadline for responses is 24 April 2024. See: LNB News 28/03/2024 80. Environment ECHA announces project to check poison centre notifications ECHA has indicated that its Enforcement Forum has...

This Practice Note examines core aspects of the UK framework for money market funds (MMFs) that stems from Regulation (EU) 2017/1131 (the EU MMF Regulation). It also looks at suggested changes to the framework, with the Financial Conduct Authority (FCA), HM Treasury and the Bank of England (BoE) working jointly to bolster its resilience and align it with post‑Brexit regulatory objectives. For background on the EU MMF Regulation, see Practice Note: EU MMF Regulation—essentials. What is an MMF? Money market funds (MMFs) are investment funds that invest in short‑term debt instruments and so play a significant role in the short‑term financing of the economy. In particular, MMFs are open‑ended, liquid investment funds that invest in fixed income through short‑term debt, for example money market instruments issued by banks, governments or companies (including treasury bills, commercial paper and certificates of deposit) which pay interest. They therefore form an important connection between demand for, and the supply of, short‑term debt. Further information on the eligible assets of an MMF is...

This Practice Note examines unlicensed medicines and the routes by which they can reach patients across the EU and the UK, such as via the UK Specials regime. It then looks at deploying authorised medicines beyond the scope of their licence (commonly termed off-label use). Lastly, the Practice Note addresses liability questions linked to using medicines without a licence. The UK’s regime governing unlicensed products is largely rooted in EU legislation. Numerous EU-derived principles and obligations remain in UK domestic law, save where particular measures provide otherwise. The Note surveys both EU and UK frameworks: analysis of EU requirements should be treated as relevant to the UK system unless distinct UK rules departing from EU law are set out separately. It also summarises pertinent EU case law; for guidance on the extent to which UK courts and tribunals are bound after the Brexit implementation period, see Q&A: Are UK courts and tribunals bound by decisions of the Court of Justice of the European Union post-Brexit? The discussion covers availability routes,...

(OMPs) are medicines that help prevent, identify or treat rare illnesses and medical conditions. Because the number of people affected is very small, without incentives, pharmaceutical companies may doubt whether sales would cover the research and development (R&D) costs of medical products to detect, prevent and treat such disorders. In the relevant EU law, 'rare' is defined as affecting fewer than five in 10,000 people in the EU. Yet most rare conditions impact fewer than one in 100,000 people. Although each individual rare disease is uncommon, they carry major public health importance and significance. There are thought to be more than 6,000 distinct rare diseases; so, while each is infrequent on its own, together they account for a substantial patient population, roughly one in every 12 people in the EU (all rare diseases combined). In the absence of incentives, it is frequently not commercially feasible for pharmaceutical companies to develop and market OMPs, and only about 5% of rare diseases currently have an authorised treatment option available...

This Agreement is entered into on [ date ] Parties [ Insert the company name ], a company incorporated in [ England and Wales ] under company number [ insert registered number ], whose registered office is at [ insert address ] (the Sponsor); and [ Insert the company name ], a company incorporated in [ England and Wales ] under company number [ insert registered number ], whose registered office is at [ insert address ] (the CRO) Each of the Sponsor and the CRO is a party and, collectively, the Sponsor and the CRO are the parties. Background The Sponsor is supporting a series of clinical trials to obtain marketing authorisation for the IMP and intends to retain the CRO to carry out certain services. The CRO possesses the requisite knowledge and experience in the design, oversight and conduct of clinical trials and agrees to provide such services to the Sponsor in accordance with the...

1 Client details Client’s name [ insert client name ] Client reference [ insert client number ] Matter ref [ insert matter number ] Matter summary [ insert matter description ] Responsible fee-earner [ insert fee earner ] Supervisor [ insert supervisor ] Has this client approached us following a joint marketing initiative with the separate business? ☐ Yes ☐ No If yes, you must exercise additional care at section 3 to ensure the client appreciates the distinction in regulatory status between our firm and the separate business and the implications of those distinctions, particularly if the matter is to be shared with the separate business. 2 The separate business and proposed introduction Name of separate business [ insert name ] Describe the services the separate business will deliver to the client [ insert description of services ] 3 Transparency Is the client acting in the course of their...