18/19 June 2024
Non-Compliance reports are published by national competent authorities in the EudraGMDP database of the European Medicines Agency (EMA). They relate to inspections both within and outside the European Community (European Union). The Non-Compliance reports are entered into the database by the national competent authorities independently using a standardised form. Such a Non-Compliance report has serious consequences for the company concerned until the deficiencies have been rectified. A suspension of the marketing authorisation as well as product recalls can be ordered.
On 2nd February 2016, the Spanish competent authority published a Non-Compliance report for the Spanish company Farma Mediterrania S.L. Beside deviations in the areas of secondary packing and QC, considerable deficiencies with regard to sterile manufacturing have been criticised. One of them relates to sterility tests: their results have been accepted uncritically although no investigation had been performed to determine the root cause of previous OOS sterility tests. Furthermore, the following major deficiencies were found:
On 19 January 2016, the Polish competent authority (GIF) released a Non-Compliance report for the Polish subsidiary Agila Specialities Polska Sp. z o.o. This Non-Compliance report relates almost exclusively to "sterile topics" and lists 29 major deficiencies - among them:
Source: EudraGMDP Database of the EMA