25 September 2024Publication
A look at EC's guidelines and priorities
With the elections and new European Union Commissioners, the European Commission (EC) President’s office, has published Political Guidelines for 2024-2029.
Life Sciences companies are operating in a rapidly changing and increasingly demanding regulatory environment. Innovation, safety and value for money are major challenges. Well devised strategies add significant value. Breach of regulatory laws and codes attracts criminal and civil sanctions.
We have put specialist regulatory expertise at the heart of our Life Sciences sector group, building a flexible, integrated team based locally in major markets to respond to our clients’ needs at any stage of the product life cycle. Our European team is complemented by expert capability in the Middle East and China.
Our international regulatory and market access team works closely with our corporate, commercial and IP teams on:
- R&D contracts
- Clinical trials
- Manufacturing agreements
- Product classification
- Market access and CE marking
- Pricing & reimbursement
- Supply chain & distribution
- Advertising & promotional activities
- IP/Patents (life cycle strategies)
- Data and regulatory exclusivity
- Regulatory enforcement and
- Sanctions/compliance (criminal)
- Industry codes of conduct/self regulation
- Transparency – data and relationships with healthcare professionals
- Administrative/public law
- Public/private partnerships with healthcare institutions
- Product recall and liability
- Business development & partnerships
Our experience
Distribution of Cosmetic Products
Advising a pharmaceutical company in connection with the legal risks surrounding the distribution of certain cosmetic products under a disputed mark in China.
Clinical Development Strategy
Advising a top 10 global pharmaceutical company on EU data exclusivity issues arising from the proposed clinical development strategy in relation to a vaccine, involving the UK, Germany, Italy, Netherlands and France.
Nano-Physical Healthcare Products
Providing strategic advice to a global leader in nano-physical healthcare products in connection with the classification of its product in the UK (when classified differently in other European countries).
Key contacts
If you have any questions, contact a member of the Healthcare and Life Sciences Regulation team for assistance:
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