MHRA Audit: One-Third of Variations Notices Denied Under New EU Regulations

Roughly 36 percent of Type 1A notifications of variations to marketing authorizations (MAs) in the UK have been rejected because they were incomplete or otherwise failed to meet new EU regulations that took effect Jan. 1, according to an audit report. The audit covers variation notifications received and processed by the Medicines and Healthcare products Regulatory Agency (MHRA) in June. The regulations cover MAs granted by the European Medicines Agency; however, the MHRA said at the time they would also apply to variations to products marketed solely in the UK.
International Pharmaceutical Regulatory Monitor