The GDP Non-Compliance Reports of 2021 - An Overview
Wholesale trade in medicinal products requires a wholesale authorisation. A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor by the national competent authority.
If the outcome of an inspection is that the wholesale Distributor does not comply with Good Distribution Practice, a statement of non-compliance may be entered into EudraGMDP. The EudraGMDP database is maintained and operated by the EMA.
Number of Reports
The number of GDP non-compliance reports entered into the EudraGMDP database in 2021 is – like the total number of reports – quite low. The following table gives an overview of the number of reports in recent years:
Year | Number of GDP non-compliance reports |
2021 | 6 |
2020 | 6 |
2019 | 6 |
2018 | 4 |
2017 | 1 |
2016 | 1 |
2015 | 0 |
2014 | 1 |
Total | 25 |
Evaluation of the Reports entered in 2021
In 2021, the following reports were entered into the database (by clicking on the report number, you will get to a summary of the respective report):
Report Number | Issue Date | Country |
24.05.01.17-03-0126 | 2021-12-03 | Germany |
G3-6300.GH_Rowi-Med_20210816 | 2021-10-01 | Germany |
sukls162731/2021 | 2021-08-06 | Czechia |
NCD/011/RO | 2021-04-15 | Romania |
1 | 2021-03-05 | Germany |
NCD/010/RO | 2021-01-22 | Romania |
The following table gives an overview of the deficiencies that led to issuing of the GDP non-compliance reports entered in 2021. The total number of deficiencies is greater than the number of reports, as in some cases several topics were listed:
Area | Details | Quantity |
Responsible Person (RP) | Doubtful reliability / No responsible person who possesses the required expert knowledge / RP does not properly perform his or her duties | 4 |
Premises / storage | No suitable and adequate premises or storage areas, installations and facilities / Storage of expired medicinal products in between those ready for trading / Storage of expired medicinal products in regular stock | 4 |
Procurement | Procuring from entities which are not authorized for wholesaling activities / Trading of medicinal products with unclear trade chain | 2 |
Quality system | No GDP conform quality system | 1 |
Change Management | No change control system | 1 |
Deviations | Deviations were not documented | 1 |
Self-Inspections | No self-inspections were performed | 1 |
Training | Information on staff training could not be provided | 1 |
Counterfeit medicines | Trading of falsified medicinal products | 1 |
CEO | Doubtful reliability | 1 |
Others | Missing connection to the securepharm-system / Company changed its address without information to or inspection of the competent authority | 2 |