The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is currently experiencing a high volume of submissions so you may encounter some delays with some applications.
Current processing times for the following applications are:
- Type 1As – 30 days
- Validation of Type 1B/IIs – 14 days
- Validation of PIQ (Article 61(3)’s) – 5 days
- Grant of BROMI’s – 14 days
- Validation of PLPI’s – 6 days
MHRA advises applicants to contact Area3-VARIATIONS: Area3-VARIATIONSemail@example.com if any submissions that have gone beyond the dates listed above.