Organisations based outside the EU and UK must have the correct legal representation in place before they:
- Undertake clinical trials
- Pursue orphan drug designations
- Secure marketing authorisations
- Receive small and medium-sized enterprise benefits
Appointing legal representation is a crucial step in meeting regulatory requirements and helps reduce the cost and time required to navigate a demanding regulatory landscape. That’s why many organisations choose to work with pharmaceutical consultancies, like MWB Consulting, who can offer specific legal representative services to sponsors.
Choosing sponsor’s legal representation
Navigating EU and UK regulations is demanding and takes considerable skill and resources. So, it’s essential to look for an organisation with in-depth expertise, a proven track record and the right resources to represent you effectively. As with much of the compliance process, it pays to begin early. Starting well before your planned market entry gives you sufficient time to vet potential representatives.
When choosing a pharmaceutical consultancy, it’s advisable to ask questions like:
- Can they provide you with a legal office in the EU and UK?
- Do they have a history of success in both these markets?
- Do they have a specialised team of legal experts they can allocate to your organisation?
- What relationships with regulatory bodies have they built up?
- Do they have the skills and resources required to support you from first entry into these markets right through marketing authorisation and beyond?
- What additional services do they offer? Can they cover everything you may need in the future?
Why choose MWB Consulting?
With UK and EU offices, we can provide an effective legal office for EMA/EU National Competent Authorities (NCAs) and MHRA liaisons. Our dedicated, in-house team of legal consultants and network of senior-level industry specialists have over 20 years of proven success in the industry, covering all aspects of legal representation in global markets for medicinal products, biologics, advanced therapy medicinal products and medical devices. We work to create trusted, collaborative partnerships to minimise risk and quickly and effectively problem-solve.
Over time, we’ve built effective working relationships with the European Medicines Agency (EMA) and Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. We’re experts in seamless communication and can draw on our extensive regulatory know-how to represent your product and development in the best possible way to maximise your chances of regulatory approval.
Need legal representation in the EU or UK?
Contact us today for an initial, free-of-charge discussion with a senior consultant about your project.
Let’s TalkBenefits of appointing a pharmaceutical consultancy
Appointing legal representation is a necessary step for organisations without a legal presence in the EU and UK to ensure they remain legally compliant. But getting the right legal representation in place can also make gaining market authorisation quicker and easier.
Legal representatives, like MWB Consulting, can help identify and address potential compliance issues before they cause delays and extra expense. Additionally, they allow you to simultaneously delegate regulatory responsibilities so you can focus on your core business objectives and tap into specialist skills and keep up to date with local market dynamics and regulatory trends.
If you’re based outside the UK or EU, ensuring you have proper legal representation in these markets is an investment in your product’s future. It helps you meet regulatory requirements and builds a foundation for sustainable growth across these markets.
The role of a sponsor’s legal representative
Once you’ve appointed legal representation, they can support your team in a variety of ways:
Clinical trials in the EU and UK
Under the EU Clinical Trial Regulation (CTR), if a sponsor does not have a registered office in the EEA, they must appoint an EEA-based legal representative before conducting a clinical trial. New, post-Brexit rules mean that if a sponsor wants to run a clinical trial in the UK and they aren’t established in the UK or EEA, they must appoint a legal representative based in one of these markets.
This applies to all clinical trials in the EU and UK for medicinal and/or pharmaceutical products and medical devices.
An EU/UK office for regulatory purposes
A legal presence is also needed in the UK or EU if a sponsor or marketing authorisation holder wants to:
- Secure marketing authorisations (MA)
- Pursue orphan drug designations (ODD)
- Receive small and medium-sized enterprise (SME) benefits
Obtaining SME designation
Registering as an SME with the European Medicines Agency (EMA) offers businesses significant savings on regulatory fees and unlocks additional support available from the agency. Pharmaceutical and biotech businesses that meet the definition of a small and medium-sized enterprise (SME) but aren’t legally established in the EU or EEA can access SME incentives through an EU/EEA-based representative.
Additional roles and responsibilities
- Act as a point of contact for all communications regarding regulations
- Draw on in-depth knowledge of local regulations to help sponsors navigate the complex regulatory landscape
- Take action quickly to reduce risk and protect patients
- Adapt their approach to keep up with evolving regulations
Need legal representation in the EU or UK?
Contact us today for an initial, free-of-charge discussion with a senior consultant about your project.
Let’s Talk