Hard Brexit: MHRA Preparations
Recommendation
7/8 May 2024
How to foster Continual Quality Improvement
Register now for ECA's GMP Newsletter
Boris Johnson's election as Prime Minister has made it very likely that the UK will leave the EU on 31 October this year. And the likelihood of a withdrawal without an agreement ("Hard Brexit ") can no longer be dismissed. Pharmaceutical authorities see challenges for pharmaceutical manufacturers in many areas, not only in terms of drug availability or drug testing.
The MHRA has already published several guidelines for a possible no-deal scenario. This concerns the following areas:
- Medical Devices
- Clinical Trials
- Biologicals and ATMPs
- List if approved countries
- Trading in drug precursors
- QPPV and PV Master File
A comprehensive overview can be found in the Collection "MHRA guidance and publications about a possible no-deal Brexit".
Related GMP News
21/02/2024
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others