Are you ready for Brexit?
We are! Diapharm is here to help pharmaceutical companies from the United Kingdom retain easy market access to the European Union even after Brexit. We look for pragmatic solutions and, if needed, can take over responsibility as a marketing authorisation holder (MAH) or European Authorized Representative (EC REP), among other roles.
Following Brexit, the United Kingdom and the EU27 will be separate legal jurisdictions. For British manufacturers and distributors of medicinal products and medical devices, this means that the UK will be a third country for the EU27. In the event of a hard Brexit, this might immediately be the case. In all other scenarios, companies would have a brief grace period to prepare for the transition.
This third-country status will at some point apply under all Brexit scenarios, even under what is known as the “Norway-plus” model. If the British government gets its way, the United Kingdom’s membership in the European Free Trade Association (EFTA) or the European Economic Area (EEA) would only be temporary for a transitional period. The Norway-plus model involving EFTA membership therefore does not provide legal certainty for MAHs.
A legal and sales organisation in a European jurisdiction is required to market medicinal products in the EU. For more than a decade, Diapharm has been successfully helping manufacturers from third countries market medicinal products in full compliance with EU Directive 2001/83/EC. Depending on the situation, we can also take on:
To market medicinal products in the EU27, the marketing authorisation holder must be domiciled within the European Union. British companies will therefore be unable to hold medicinal product marketing authorisations in the European Union following Brexit, necessitating a transfer to a new marketing authorisation holder based in the EU. Please refer to CMDh/361/2017 for more information. Batch release testing of medicinal products may take place either in the EU or in a country that has signed a mutual recognition agreement (MRA) with the EU. To date, however, the United Kingdom is not on the EMA’s list of MRAs. Certain processes, such as EU market release (batch release), must be performed in the European Union, not the EEA. As a result, even British membership in the EEA – commonly known as the Norway-plus model – would not be sufficient.
Manufacturers and distributors of medical devices or IVDs who do not have a registered office in Europe, or no longer have a seat within the community, need to appoint an European Authorized Representative (EAR or EC REP). According to the Medical Device Regulation (MDR 2017/745), the EC REP is responsible for the products on the market in the name of the manufacturer. The representative acts as a contact for the authorities and bears third-party liability for the use of these products. Diapharm can take on this responsibility on your behalf.
Manufacturers of (substance-based) medical devices have successfully relied on our model for over ten years now. Diapharm currently acts as an European Authorized Representative or legal manufacturer for more than 30 million packs of medical devices on the market in Europe. We offer a wide range of additional functions to round out this service:
Distributors based in the EU that market medical devices from the United Kingdom should remember that once the Brexit process has been completed, the EU will consider the UK to be a third state, turning EU distributors into importers! This can have a tremendous impact with regard to issues such as product liability (85/374/EEC). Please inform yourself ahead of time.
For ten years now, Diapharm’s Hälsa model has allowed it to meet a wide range of individual requirements for medicinal products and medical devices alike. While some clients outsource every mandatory role to us in order to access the European market securely and as quickly as possible, others make use of a separate legal entity based on our Hälsa blueprint, or they take advantage of selected individual services only, such as our EC REP or QP options.
We would be happy to help you decide which model is the right fit for your Brexit needs. Contact us!