21 September 2017 - Authored by:Erin Currie
A number of position papers have recently been published as negotiations continue on the UK’s withdrawal from the EU. One such position paper from the UK is the Continuity in the availability of goods for the EU and the UK, published on 21 August 2017, which sets out proposals that will be applicable to the regulation of medicines, medical devices and agricultural products. The UK’s proposal for the continuity of the availability of goods is set against the backdrop of the common regulatory systems and “the ambition for a close future relationship”. This paper focuses on the following four principles:
- Goods placed on the market should continue to circulate freely without additional requirements or restrictions;
- Businesses should not be required to duplicate compliance activities undergone before the withdrawal date;
- There should be the facilitation of continued oversight of goods in circulation to ensure that such goods continue to comply with legislation;
- Where goods are supplied with services, there should be no restriction on the provision of these services.
Overall, the UK is proposing that for goods placed on the market before the withdrawal date, things should continue largely as they are to provide legal certainty and avoid disruption for businesses and consumers. This includes ensuring that there are no requirements to change labelling for products that are already in circulation and that the validity of approvals, registrations and authorisations that have been issued by third parties continue to be recognised. To ensure the continued monitoring of such goods, such as adverse event reporting for medicines, the UK proposes that there be continued recognition of assessment bodies and an ongoing exchange of data.
The continued recognition of approvals is proposed to extend to compliance activities that have been undertaken prior to the withdrawal date, as well as those that are ongoing commitments. For example, where a manufacturing facility has been approved to ensure production is in accordance with Good Manufacturing Practice before the withdrawal date, there should be no additional requirement for re-inspection, and any further compliance activity should be conducted as originally intended. Additionally, where there is a person responsible for compliance (such as an Authorised Representative for medical devices), that person should be able to continue to carry out that responsibility for goods placed on the market prior to withdrawal, regardless of whether they are based in the UK or EU.
These proposals are in line with the recommendations of experts and industry groups in the UK; they have been well-received as a pragmatic approach that would avoid disruption for businesses and customers during the transition period.
As negotiations continue, further such position papers will undoubtedly follow. The full list of documents published by the UK government in relation to Article 50 negotiations can be found here.