News

Acting as a MHRA Approved Compliance Monitor for GDP

The Medicines and Healthcare products Regulatory Agency (MHRA) began a pilot programme for monitoring GMP and GDP activities, whereby approved consultants, so-called Compliance Monitors (CM), will supervise the completion of an agreed Compliance Protocol (CP). Consultants interested in being named as eligible to act as a CM for GDP (or GMP), have to fill out the MHRA "Compliance Monitor (CM) Application Form".

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GDP-relevant Documents from FDA and USP Currently in Commenting Process

Currently, several GDP-relevant documents from the U.S. Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) are in the commenting process. We have prepared an overview.

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FDA posts Webinar on Proposed Rule for the Licensure of WDDs and 3PLs

The U.S. Food and Drug Administration (FDA) has posted a webinar on the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)". The webinar aims to help stakeholders submit comments and understand the proposed changes.

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RP for GDP: Which Duties can be Delegated?

The area of responsibility of the Responsible Person for Good Distribution Practice is quite extensive. Therefore, the question arises which tasks actually have to be performed personally and which duties can be delegated.

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Are You Recall Ready?

The FDA finalized the guidance on voluntary recalls to help industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco products.

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Update of the EMA Q&As on parallel Distribution of Medicinal Products

The so-called "Frequently asked questions about parallel distribution" for centrally authorised medicinal products were updated in April 2022 and published on the EMA website.

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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.

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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.

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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.

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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.

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