Good Distribution Practices News

21.04.22

Overview of the Incoterms Rules

The Incoterms rules are frequently used in international and domestic contracts. In this article, you will get an overview of the Incoterms 2020 and their meaning.

more

21.04.22

MHRA Releases New Version of the Green Guide

The 2022 edition of the Rules and Guidance for Pharmaceutical Distributors (the "Green Guide"), compiled by the Medicines and Healthcare products Regulatory Agency (MHRA), was published. It provides an authoritative source of European good distribution practices and UK guidance, information and UK legislation on these activities.

more

21.04.22

MHRA Releases Recording of the Medicines Supply to Northern Ireland Webinar

On either 02 or 03 February 2022, interested parties could take part in a live webinar of the Medicines and Healthcare products Regulatory Agency (MHRA) on Medicines Supply to Northern Ireland. A recording of the webinar, excluding the Q&A sessions, was now published.

more

13.04.22

US Track & Trace Requirements

The FDA has issued a questions and answers document to assist industry and State and local governments in understanding the effects of the Uniform National Policy on drug product tracing.

more

23.03.22

Version 19 of the Q&As on Safety Features

The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Do the UIs of reference and retention samples taken from stock have to be decommissioned?

more

17.03.22

GDP for Active Substances used as Starting Materials in Veterinary Medicinal Products: Obligation to Perform Audits

The European Medicines Agency (EMA) has updated its list of questions and answers on the GMP/GDP guidelines. The newly added chapter deals with the requirements for active substances used as starting materials in veterinary medicinal products. Among other things, it is clarified that the Veterinary Medicines Regulation requires manufacturers and importers of veterinary medicinal products to perform audits based on a risk-assessment on the manufacturers, distributors and importers from whom they source the active substances.

more

17.03.22

How often should GDP Self-Inspections be performed?

According to the GDP guidelines, regular self-inspections should be performed. But what is considered as an appropriate regular interval?

more

17.03.22

U.S. Pharmaceutical Distribution Supply Chain: Revised Draft Guidance on Verification Systems

The U.S. Food and Drug Administration (FDA) has issued a revised draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs. This document addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place.

more

15.02.22

Proposed Rule for the Licensure of WDDs and 3PLs published

The U.S. Food and Drug Administration (FDA) has announced the availability of the proposed rule National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs). According to the agency, the proposed rule, when finalized, would provide greater assurance that supply chain participants are sufficiently vetted and qualified to distribute prescription drugs, further strengthening the supply chain.

more

15.02.22

GDP Non-Compliance Report due to GDP Violations concerning RP, Supplier Qualification, Operations and Trading

The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 18 January 2022 into the EudraGMDP database.

more

15.02.22

The GDP Discussion Forum

The European GDP Association, representing more than 4.000 professionals from across the globe, offers a Discussion Forum free of charge for its members. It gives you the opportunity to address your GDP-related questions to a large audience. To get an idea, take a look here.

more

15.02.22

Active and Passive Shipping Systems and Transport Equipment

In this article, we will provide some information and examples of active and passive shipping systems and equipment used for the transport of time and temperature sensitive pharma products.

more

09.02.22

EU: Strengthening the EMA

A regulation strengthening the role of the EMA in crisis preparedness and management has been published in the Official Journal of the EU. The document also assigns several new tasks to the EMA.

more

18.01.22

EU Commission amends Delegated Regulation on Safety Features again

In order to ensure that medicinal products continue to be marketed with a unique identifier (UI) in Northern Ireland, Cyprus, Ireland and Malta, the Commission further extends the temporary derogation from the requirement to decommission UIs of products exported to UK.

more

18.01.22

Wholesale Distribution of Medicinal Products - Obligation to Notify Changes

Wholesale trading of medicinal products in Germany requires an authorisation according to Section 52a of the Medicinal Products Act (Arzneimittelgesetz – AMG). The holder of the authorisation must notify the competent authority in advance of any fundamental changes. A wholesaler from Brandenburg, Germany, did not comply with this notification requirement, as a GDP Non-Compliance Report published in October 2021 shows.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics