The changes in UK pharmaceutical law impact companies based in the UK, companies which hold a Marketing Authorization (MA) in the UK, and companies which have an EU Qualified Person for Pharmacovigilance (QPPV), Local Person for Pharmacovigilance (LPPV), Qualified Person (QP), Responsible Person (LP) in the UK. Protect your business and make sure you are prepared with:
- QPPV and LPPV services including PSMF Development and Pharmacovigilance (PV) Auditing
- QP and RP services
- Applying for and maintaining regulatory applications and licenses
Whether you need help to maintain or secure a marketing authorization, ProPharma Group offers responsive and reliable services to support clients during the transition period and after.
UK Regulatory System: Post-Brexit
Our regulatory team is proud to provide expert EU regulatory assistance, helping our clients meet centralized, decentralized, and national requirements. The focus of our team of European regulatory consultants remains to continue to provide expert EU regulatory consulting services and these services are unaffected by any potential effects of a Hard-Brexit.
Post-Brexit, the UK government has established a stand-alone regulatory system to ensure its citizens have access to safe and innovative medicines. To achieve this the UK regulatory affairs system is being modified, and a number of initiatives are rolling out throughout 2021. The MHRA will continue to provide an active, agile, and innovative presence in the development of global regulatory standards.
Our regulatory consultants can help marketing authorization holders (MAHs) and companies developing medicines to navigate the emerging procedures being established by the MHRA.
Maintaining Regulatory Compliance for Existing Products
For those products currently marketed in the UK, our consultants provide the following services to maintain regulatory compliance post-Brexit:
- Support the conversion of Community Marketing Authorizations (CMAs) to Great Britain Marketing Authorizations (MAs)
- Support to grandfathering activities, related notifications, baseline submissions, and managing lifecycle changes
- Portfolio review and regulatory strategy
- Variations, renewals, line-extensions
- New packaging information
- In-flight and in parallel MA procedures for products undergoing EU centralized MA assessment
- UK contact point for non-UK established MAHs
Supporting Innovators
The emergence of the expanded UK regulatory affairs system provides areas of opportunity for companies developing new and innovative therapeutics. Our team of regulatory consultants can help companies in the following interactions with the MHRA:
- Scientific Advice
- Regulatory advice from the Innovation Office
- UK MAAs (Accelerated Assessment Procedure, Rolling Review, Adoption of EU commission decisions, Conditional Marketing Authorizations, Orphan Drug Designation Application)
- Regulatory strategies and advice on how to make use of the UK in global clinical development programs
- Pediatric Investigational Plans (PIPs)
- Clinical Trial Applications (CTAs)
- Promising Innovative Medicine (PIM) designation
- Our consultants are regulatory experts in cell and gene therapies (ATMPs)
Allied Services
In addition to the topics covered above our team of experts also provide consulting support for other related services including:
- Clinical and nonclinical overview writing
- PIL user testing
- CTD publishing to support activities in ICH regions and Rest of World markets
- Chemistry, manufacturing, and controls (CMC) documentation support
- Brexit-related pharmacovigilance (PV) and compliance services