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Information requirements under the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013—checklist

Information requirements under the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013—checklist FORTHCOMING CHANGE: On 24 May 2024, the Digital Markets, Competition and Consumers Bill received Royal Assent, becoming the Digital Markets, Competition and Consumers Act 2024 (DMCCA 2024) and coming partly into force on that date. DMCCA 2024, s 251 (which is not yet in force) will revoke the Consumer Protection from Unfair Trading Regulations 2008 (CPUTR 2008), SI 2008/1277. Once revoked, the provisions presently contained in the CPUTR 2008 will be replaced by Part 4 of DMCCA 2024 (which largely replicates the requirements of the CPUTR 2008). The DMCCA 2024, Part 4, Chapter 2 (which is not yet in force) removes subscription contracts from the scope of the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013, SI 2013/3134 (CCR 2013). This Checklist will be updated for these changes in due course. For further information on the DMCCA 2024, including a detailed comparison of the CPUTR 2008 and Part 4 of DMCCA 2024, see Practice Note:...

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Marketing authorisations: EU decentralised procedure—flowchart

Marketing authorisations: EU decentralised procedure—flowchart No medicinal product may be placed on the market unless it has been approved. This Flowchart outlines the procedure for obtaining an approval known as a marketing authorisation (MA) through the EU decentralised procedure. The decentralised procedure is used to obtain MAs for medicinal products in more than one EU Member State in parallel. A medicine may only be authorised in individual Member States in parallel if it is not mandated to be authorised via the centralised procedure (ie products containing new active substances; products which constitute a significant therapeutic, scientific or technical innovation or products for which the granting of an EU authorisation would be in the interest of patients or animal health at EU level) and medicines that have not received an MA in any Member State already at the time a decentralised application is

EU centralised marketing authorisation procedure—flowchart

EU centralised marketing authorisation procedure—flowchart No medicinal product may be placed on the market unless it has been approved. This Flowchart outlines the procedure for obtaining an approval, known as a marketing authorisation (MA) through the EU centralised procedure. Under the centralised authorisation procedure, pharmaceutical companies submit a single MA application to the European Medicines Agency (EMA) and successful applicants receive a centralised MA which is granted by the European Commission. This Flowchart should be used in

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What does IP completion day mean for Life Sciences? [Archived]

What does IP completion day mean for Life Sciences? [Archived] ARCHIVED: This Practice Note has been archived and is no longer maintained. 11 pm (GMT) on 31 December 2020 marked the end of the implementation period put in place to enable the UK to transition away from the EU’s laws and institutions. At this point in time (referred to in this document as ‘IP completion day’) there was an immediate and significant change in the UK’s legal regime. This Practice Note explains the implications of this change in relation to the following life sciences areas: • Overview—what happened on 31 December 2020 • How does Brexit impact the life sciences sector? • EU-UK Trade and Cooperation Agreement—life sciences provisions • Medicinal products • Medical devices • Clinical trials For a tracker of key life sciences Brexit legislation and guidance, see Practice Note: Life sciences—Brexit tracker 2020–2022 [Archived]. For the impact of the end of the implementation period on patents and supplementary protection certificates (SPCs), see Practice Note: What does...

Pharmaceutical trade marks and parallel imports

Pharmaceutical trade marks and parallel imports Pharmaceutical trade marks: regulation and naming procedures In most fields of business, trade mark owners have a relatively free hand in selecting the brands they use to market their goods or services. In general, where there is no risk of confusion on the part of the relevant consumer with an earlier brand, a trade mark will be free for use. This is not the case with respect to trade marks for pharmaceutical products, which are subject to an extra layer of regulation in order to protect public health. Pharmaceutical trade marks can only be put into commercial use once they have been granted a marketing authorisation (MA). In determining whether to grant an MA, the competent authorities will decide whether the trade mark poses a risk to public health. This decision is not reached through a classical trade mark infringement assessment, but instead centres on the potential for medication errors which could lead to serious health risks. The various considerations...

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Medicinal products due diligence questionnaire

Medicinal products due diligence questionnaire Introduction This medicinal products regulatory due diligence questionnaire relates to the proposed purchase by [insert buyer name] (the Buyer) of the [entire share capital of [insert name of target company] Limited incorporated in England and Wales under number [insert company number] (the Company) OR [insert description of the business to be acquired] (the Business) as a going concern, together with certain assets used in the Business] from [insert seller name] (the Seller) (the Proposed Acquisition). This questionnaire is designed to enable the Buyer, the Buyer’s solicitors and other professional advisors to obtain the legal information relating to the medicinal products UK and EU regulatory compliance of the [Company OR Business] which the Buyer requires to assist in the valuation of the [Company OR Business] and with the negotiation of the Proposed Acquisition. Please answer every question fully. Please provide your answers in italics underneath each question and provide copies of all relevant documentation, ensuring...

Applicable Laws and Medical Product Law definitions—life sciences

Applicable Laws means: (a) [Medical Product [Law OR Regulation] and ]any law, statute, regulation, by-law or subordinate legislation in force from time to time, and all subsequent amendments thereto, applicable to a Party or any part of the [insert description of the product or activity to which the agreement relates] in any jurisdiction in which the [insert description of the product or activity to which the agreement relates] [is OR are] [supplied OR carried out]; (b) the common law and laws of equity as applicable to the parties from time to time; (c) any binding court order, judgment or decree; (d)

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What is the definition of a monograph under Regulation 251 of the Human Medicines Regulations 2012?

What is the definition of a monograph under Regulation 251 of the Human Medicines Regulations 2012? Please note that monographs also exist for herbal medicinal products (ie herbal monographs) which are not specifically referenced as considered outside the scope of this reply (and our content). Regulation 251 of the Human Medicines Regulations (HMRs 2012), SI 2012/1916 deals with medicinal product compliance with standards ‘specified in certain publications’. The regulation’s reference to monographs refers to drug ‘monographs’ (ie pharmacopoeial monographs) which, although is not defined in the statute, does refer to a term of art for medicinal products. Monographs refer to a written document that contains all of the information about a specific drug, such as its uses, doses, medicinal forms, warnings/safety issues, side-effects and other information, which the British Pharmacopoeia Commission devises and the British National Formulary (BNF) will publish (see: NICE’s BNF website for a definition and monograph listings and the British Pharmacopoeia website for ‘Contribute to monograph development and improvement’) in the UK. In the EU, the European...

Would a gel that contains hydrogen peroxide and is designed to be used subgingival and interproximal to control the pathogens that cause gum disease for the treatment of gum disease be considered as a medical device or a medicinal product?

Would a gel that contains hydrogen peroxide and is designed to be used subgingival and interproximal to control the pathogens that cause gum disease for the treatment of gum disease be considered as a medical device or a medicinal product? Summary The following facts would support the conclusion that a gel that contains hydrogen peroxide and is designed to be used subgingival and interproximal to control the pathogens that cause gum disease for the treatment of gum disease is a medicinal product, as opposed to a medical device: • the product is presented as having a medical claim, namely treatment of gum disease • a judgment of the Court of Justice held that Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code must be interpreted as meaning that, for a substance to be regarded as exerting a ‘pharmacological action’ within the meaning of that provision, it is not necessary for there to be an interaction between the molecules of which it consists and a cellular constituent of the user’s...

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EU Law weekly highlights—5 December 2024

This week's edition of EU Law weekly highlights includes analysis on HSBC losing its challenge to the €32m Euribor rigging fine. In addition, this week the Council of the EU adopted the EU Cyber Solidarity Act and an amendment to the EU Cybersecurity Act and approved conclusions to address labour and skills shortages, the European Data Protection Board approved the certification criteria for EU Data Protection Seal under EU GDPR, the European Commission introduced data specifications for alternative fuels infrastructure rollout, proposed common EV charging and hydrogen rules and opened consultations on implementing regulations for EUDI Wallets, and the European Central Bank published the second progress report on the preparation phase of the digital euro.

Life Sciences weekly highlights—5 December 2024

This week's edition of Life Sciences weekly highlights includes a Law360 analysis on the US FDA’s final guidance on decentralised clinical trials. Also included, is news that the HRA proposed changes to simplify the informed consent process for low-risk clinical trials in the UK, the MHRA announced the selection of five innovative AI technologies for its AI Airlock regulatory sandbox pilot scheme and it issued a final call for marketing authorisation holders to comply with the incoming Windsor Framework arrangements for medicines by 31 December 2024, the ICH launched a consultation on a global multi-regulatory technology platform for the joint assessment of variations to drug licences, MedTech Europe urgently called for reforms to the EU’s medical devices regulatory frameworks, the Association of British HealthTech Industries (ABHI) submitted a comprehensive response to the UK government’s Industrial Strategy Green Paper and news that the EMA revised its Q&A guidance on good manufacturing and distribution practices (GMP/GDP), among other stories.