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Cover of the Good Distribution Practice for Active Substances Guidance
Cover if the GDP Guidance on Interpretation and Implementation

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GDP Non-Compliance Report for Romanian Wholesale Distributor

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The competent authority of Romania (National Agency for Medicines and Medical Devices of Romania) has entered a new GPD Non-Compliance Report dated 15 April 2021 into the EudraGMDP database.

During an inspection conducted in March 2021, it came out that this company does not comply with the Good Distribution Practice requirements: "The company failed to comply with GDP legislation regarding activities performed (e.g. procuring from entities which are not authorized for wholesaling activities). The company does not ensure the services of responsible person."

As a consequence, the wholesale permission was suspended.

Based on the information gained during the inspection, the company only supplied medicines to Romanian customers. According to the authority, there is no need to recall the medicines distributed by this wholesaler.

Source: EudraGMDP Database (Report Number: NCD/011/RO)


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