Good Distribution Practices News

26.05.20

COVID-19: How to manage temporary GDP Process Changes and Risks

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a post on temporary changes in Good Distribution Practice (GDP) in the MHRA Inspectorate Blog.

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26.05.20

COVID-19: Update of the Q&A document - Validity of GDP Certificates and Wholesale Authorisations

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the first revision of the common document "Questions And Answers On Regulatory Expectations For Medicinal Products For Human Use During The Covid-19 Pandemic". The update includes a question on GDP certificates and wholesale authorisations.

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29.04.20

Fraud in the Supply Chain: Beware of false Offers during Corona Crises

During the current Sars-CoV-2 outbreak, there are sometimes delivery problems with medicines, medical devices and protective equipment. Unfortunately, this also brings up many fraudsters, as a case revealed by Interpol shows.

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22.04.20

Version 17 of the Q&As on Safety Features for Track & Trace

The European Commission has published Version 17 of the "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use".

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08.04.20

COVID-19: Temporary Regulatory Flexibilities for Wholesalers in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a list of temporary regulatory flexibilities on good distribution practices (GDP) that will be allowed to address the current exceptional circumstances during the coronavirus (COVID-19) outbreak.

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30.03.20

COVID-19: Beware of falsified medicines from unregistered websites

The European Medicines Agency (EMA) is urging the general public not to buy medicines from unauthorized websites and other vendors aiming to exploit fears and concerns during the ongoing pandemic.

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30.03.20

Falsified Medicines: MHRA publishes Class 4 FMD Medicines Information

The Medicines and Healthcare products Regulatory Agency (MHRA) is currently investigating an incident where several medicines appear to have left the legal supply chain.

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26.03.20

EMA on potential Impact of Coronavirus

The EMA and its partners are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains into the EU.

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26.03.20

EU GMP Annex 21 finally published

Annex 21 to the EU-GMP Guidelines (Importation of medicinal Products) has been published as a draft. It summarises the GMP requirements for importers of medicinal products.

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11.03.20

UK Changes Import Restrictions for Cannabis

UK will implement faster access to medicinal cannabis as import restrictions are changed. Thus, patients will be able to get their treatment in days rather than months.

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18.02.20

FDA Warning Letter for receiving potentially unsafe drugs

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving potentially unsafe drugs from Chinese suppliers.

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17.02.20

Falsified Medicines: New EU Aide Memoire for GDP

The European Commission has published an aide memoire for Good Distribution Practices (GDP) inspection of wholesalers’ compliance with Commission Delegated Regulation (EU) 2016/161 for safety features.

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24.10.19

Brexit: RPs for Import from the EU

MHRA gives further guidance for a new Responsible Person function, the RPi - Responsible Person (import).

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24.10.19

FDA to introduce Wholesale Distributor Verification Requirements

FDA announced the availability of a final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product-Compliance Policy".

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24.10.19

New Q&As on Chapter 4 and 5 of the EU-GDP Guidelines

A set of new FAQs has been published on Chapter 4 (Documentation) and Chapter 5 (Operations).

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