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GDP Non-Compliance Report for Austrian Wholesale Distributor

On 09 October 2023, the Austrian Medicines and Medical Devices Agency has entered a new GPD Non-Compliance Report into the EudraGMDP database. The authority blames the company in question for a whole series of GDP violations.

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GDP Non-Compliance Report for Spanish Wholesale Distributor

The Spanish Agency Of Medicines And Medical Devices has added a new GDP Non-Compliance Report to the EudraGMDP database. During an inspection of a wholesale distributor, a series of deviations from Good Distribution Practice were found. This led to a suspension of the company's authorisation for procuring, holding, supplying and storage by contract of human medicinal products.

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Ozempic Falsifications: BfArM starts Investigation

The German Federal Institute for Drugs and Medical Devices (BfArM) has taken over coordination in the case of the counterfeit diabetes drug Ozempic®, as several German states are now actively involved in the case. The agency advises all pharmaceutical companies, wholesalers as well as pharmacies to check all packages of the drug Ozempic® with utmost care.

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GDP-Non-Compliance-Report für österreichischen Großhändler

Am 09. Oktober 2023 hat die zuständige österreichische Behörde (BASG - Bundesamt für Sicherheit im Gesundheitswesen) einen neuen GDP-Non-Compliance-Report in die EudraGMDP-Datenbank eingestellt. Die Behörde wirft dem betreffenden Unternehmen eine ganze Reihe von GDP-Verstößen vor.

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GDP-Non-Compliance-Report für spanischen Großhändler

Die zuständige spanische Behörde (Spanish Agency Of Medicines And Medical Devices) hat einen neuen GDP-Non-Compliance-Report in die EudraGMDP-Datenbank eingepflegt. Bei der Inspektion eines Großhändlers wurden eine ganze Reihe von GDP-Verstößen festgestellt. Als Konsequenz wurde die Erlaubnis (Beschaffung, Vertrieb und Lagerung im Lohnauftrag von Humanarzneimitteln) aufgehoben.

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US-Verifizierungsanforderungen: 1 Jahr mehr Zeit für Großhändler und Abgabestellen

Um mögliche Unterbrechungen im Vertrieb bestimmter verschreibungspflichtiger Arzneimittel in den Vereinigten Staaten zu minimieren, beabsichtigt die FDA, nicht vor dem 27. November 2024 gegen Händler vorzugehen, die die Produktkennungen verdächtiger oder illegaler Produkte nicht verifizieren.

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FDA's Guidance on Track & Trace Standards

The FDA published the final guidance on standards for the interoperable exchange of track & trace information for certain human prescription drugs.

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Swissmedic Plans Database for Swiss GDP Certificates

Swissmedic plans to bring a SwissGMDP database into operation, which will list the GMP and GDP certificates of all companies in Switzerland with a valid establishment licence issued by Swissmedic. The database will make it possible to view the GMP/GDP status of a company easily and free of charge.

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US Verification Requirements: 1 Year Additional Time for Wholesale Distributors & Dispensers

To minimize possible disruptions in the distribution of certain prescription drugs in the United States, the FDA does not intend to take action before 27 November 2024 against dispensers who do not verify the product identifiers of suspect or illegitimate products.

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GDP in the US: Additional FDA Guidances on DSCSA

In the last few days and weeks, the U.S. Food and Drug Administration (FDA) has published several guidance documents related to the requirements under the Drug Supply Chain Security Act (DSCSA). Under the DSCSA, trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) are subject to certain requirements for enhanced drug distribution security.

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