Good Distribution Practices News

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.

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.

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.

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.

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).

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".

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).

16.10.19

Version 16 of the Q&As on Safety Features for Track & Trace

The just published Version 16 of the Q&A´s on Safety Features puts a strong focus on Q&As addressing false alerts due to incorrect scanning by end-users.

09.10.19

How to get GMP Certificates, Importation Licenses & Broker Registrations in UK?

The MHRA recently provided details for new licence applications and variations on the agency´s Inspectorate Blog - together with some helpful links.

01.10.19

European GDP Association nominates Director Regulatory Affairs and Communication

The European GDP Association, representing more than 2.000 professionals from across the globe, has nominated Prabjeet Dulai as Director Regulatory Affairs and Communication.

01.10.19

GDP: The growing Issue of Theft

The british MHRA is currently publishing a series of blog posts discussing the theft of medicines and the risk to public health.

01.10.19

USP revises Storage and Transport Chapters

The United States Pharmacopeia (USP) is currently introducing various chapters and stimuli articles. Some of these are also relevant for storage and transport activities.

04.09.19

EMA publishes first two Guidances on Drug Shortages

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two guidance documents which can be seen as foundation for a long way to diminish shortages of medicinal products.

19.08.19

How to detect Falsified Medicines

Falsified medicines repeatedly occur in the supply chain. The MHRA now provides information on how to detect them.

19.08.19

New GDP Non-Compliance Reports

New GPD Non-Compliance Reports have been published in the EudraGMDP database, leading to a suspension of the WDA of the inspected companies.

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Annex 1 Intensive Training Course - Live Online Training

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Good Distribution Practices News

EU GMP Annex 21 finally published

UK Changes Import Restrictions for Cannabis

FDA Warning Letter for receiving potentially unsafe drugs

Falsified Medicines: New EU Aide Memoire for GDP

Brexit: RPs for Import from the EU

FDA to introduce Wholesale Distributor Verification Requirements

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

Version 16 of the Q&As on Safety Features for Track & Trace

How to get GMP Certificates, Importation Licenses & Broker Registrations in UK?

European GDP Association nominates Director Regulatory Affairs and Communication

GDP: The growing Issue of Theft

USP revises Storage and Transport Chapters

EMA publishes first two Guidances on Drug Shortages

How to detect Falsified Medicines

New GDP Non-Compliance Reports

Recommended Event

Annex 1 Intensive Training Course - Live Online Training Requirements on Aseptic Manufacturing and Approaches for Implementation

Good Distribution Practices News

EU GMP Annex 21 finally published

UK Changes Import Restrictions for Cannabis

FDA Warning Letter for receiving potentially unsafe drugs

Falsified Medicines: New EU Aide Memoire for GDP

Brexit: RPs for Import from the EU

FDA to introduce Wholesale Distributor Verification Requirements

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

Version 16 of the Q&As on Safety Features for Track & Trace

How to get GMP Certificates, Importation Licenses & Broker Registrations in UK?

European GDP Association nominates Director Regulatory Affairs and Communication

GDP: The growing Issue of Theft

USP revises Storage and Transport Chapters

EMA publishes first two Guidances on Drug Shortages

How to detect Falsified Medicines

New GDP Non-Compliance Reports

Recommended Event

Annex 1 Intensive Training Course - Live Online Training Requirements on Aseptic Manufacturing and Approaches for Implementation

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