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 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

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

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



Deviations were not documented

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


CEO Doubtful reliability


Others Missing connection to the securepharm-system /
Company changed its address without information to or inspection of the competent authority

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