12-15 October 2021
The EMA (European Medicines Agency) published two Non-Compliance Reports for the Spanish companies Euro Far Alergi S.L. and Angulema S.L. in Madrid. The Spanish national competent authority "Spanish Agency of Medicines and Medical Devices" inspected both companies and found several critical and major deficiencies. Those ultimately lead to a suspension of the MIA, the recall of all produced batches and a prohibition of supply.
Non-compliance reports are published in the EudraGMDP database of the European Medicines Agency (EMA) by European national competent authorities. They refer to inspections inside as well as outside of the European Union. The non-compliance reports are independently submitted into the database by National Competent Authorities via a standardised form. For the company concerned, a non-compliance report has severe consequences until the violations are rectified. Amongst other things, a suspension of the marketing authorisation as well as recalls of the products in question could be mandated.
List of the deficiencies found at Euro Far Alergi, a manufacturer of aseptic autovaccines as well as individual vaccines made from bacterial and allergenic extracts
List of deficiencies found at Angulema, a manufacturer of immunological products
Source: EMA EudraGMDP database (see "Non-Compliance Report")