BREXIT
Case Safety Report (ICSR) is an adverse event report for an individual patient and is a source of data in pharmacovigilance. A Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined points in time post-authorisation.
Online sellers
The EU common logo for online sellers currently allows sale of medicines throughout EU countries and can be issued by the MHRA and other EU competent authorities. In order to sell into the EU, EU-based online sellers have to register, comply with relevant requirements and display an EU common logo linked to the competent authority in which they are based. As they would be outside of the EU, UK-based online sellers would no longer be required to do this. For the UK market, the government proposes to explore requiring the use of new ‘UK logo’ for UK-based online sellers from 2021.
Good X Practice (GxP) Guidelines
GxP refers to guidelines established to ensure that businesses working in regulated industries, such as pharmaceuticals, make products that are safe, fit for use, and which have met strict quality standards throughout the entire process of production. The “x” stands for the particular field, for example manufacturing (GMP) or distribution (GDP) and so on.
In the event of a no deal scenario the UK proposes to continue using, until further notice, the EU Good Manufacturing Practice and Good Distribution Practice guidelines, as issued under Article 47 and 84 of the 2001 Directive.
Parallel distribution and parallel imports
Parallel imports are goods produced genuinely under protection of a trademark, patent, or copyright, placed into circulation in one market, and then imported into a second
The ongoing uncertainty around the eventual Brexit outcome could also diminish the number of foreign workers in the NHS and the wider healthcare sector.
market without the authorisation of the local owner of the intellectual property right.
Brexit does not mean that parallel
imports of medicines will cease. Under the TRIPS agreement – the Agreement on Trade-Related Aspects of Intellectual Property Rights, an international legal agreement which governs international rules around intellectual property and trade - countries may choose their own exhaustion regime (for products that have been sold by an intellectual property owner) which means they can determine whether or not to allow parallel imports. If there’s no deal, the UK will
unilaterally align to the EU/EEA exhaustion regime from exit day to provide continuity in the immediate term for businesses and consumers and ensure that parallel imports of goods, such as pharmaceuticals, can continue from the EU/EEA. The government is considering all options for how the exhaustion regime should operate after this temporary fix. Any substantial changes to the exhaustion regime will occur only after a full research programme and consultation.
The government said that its intention is to convert all currently approved Parallel Distribution Authorisations of CAPs into parallel import licences. In order to grant parallel import licences after exit day the MHRA would also require full product information from the source country competent authority in order to verify the safety of the medicine and that the product is essentially the same as the reference product on the UK market.
Medical devices on the UK market
For a time-limited period, the government would continue to recognise the CE Mark on medical devices, which demonstrates their conformity with EU regulatory requirements. During this period, devices would be accepted on the UK market if they meet all EU requirements, which for all but the lowest-risk devices would include certification by EU NBs. Further detail on the future process after this temporary situation of bringing a medical device onto the UK market will be subject to consultation in due course.
Notified bodies
UK-based NBs would, in a ‘no-deal’ scenario, no longer be able to assess the conformity of medical devices for devices to receive the CE mark and enter the EU market. Therefore, the MHRA will no longer be able to oversee NBs in the way that it does now.
Post market surveillance of devices
Currently, post-market safety data is shared across all members of the European regulatory network for devices (EU, EEA, Turkey and Switzerland), and any disagreement over the marketing of a device can be escalated through regulator forums such as the Medical Devices Coordination Group, and potentially through the European Commission and Court of Justice of the European Union.
If there’s no deal, the MHRA would continue to perform national post-market surveillance of medical devices on the UK market, and able to take a national decision over the marketing of a device in the UK, regardless of the position of the European regulatory network, or any decision of the CJEU.
Clinical trial applications
As clinical trials are currently managed nationally, UK clinical trial applications will continue to be authorised by the MHRA and ethics committees as they are now. The UK ability to participate in multinational trials will also not change.
MHRA will be improving processes to enable closer working with ethics bodies and allowing a single application and a single national decision in the UK. The initial pilot work has started and would continue to be developed post exit.
Legal presence
At present, a sponsor or their ‘legal representative’ should be based in the EU or
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