GDP Non-Compliance Report: Failure to Meet the GDP Principles of Cold Chain Products

Recommendation

29/30 November 2022

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Temperature controlled Transports of Medicinal Products

The competent authority of Portugal (National Authority of Medicines and Health Products, I.P.) has entered a new GPD Non-Compliance Report dated 24 May 2022 into the EudraGMDP database.

On 17 May 2022, the authority inspected a company located in Azambuja, Portugal . During that inspection, it came to light that the company does not comply with the GDP requirements referred to in Article 84 of Directive 2001/83/EC.

In the report, the authority lists the following four deficiencies: "The wholesaler does not comply with the GDP principles of cold chain products, as the procedure in case of breakdown cold chamber wasn`t triggered." Further details on the nature of the violation are not provided by the authority.

As a consequence, the wholesale authorisation concerning cold chain products (requiring low temperature handling) was suspended.

Source: EudraGMDP Database (Inspection Date: 17 May 2022; Report Number: A015/09/H/006/2021/I02 NCR). *

* To find the respective report, please click on "Non-Compliance Reports" in the menu on the left-hand side and select in "From Date / To Date" the month the inspection took place. After clicking on "Search" the results list will be displayed, from which you can choose the report with the number mentioned above.