Good Distribution Practices News

Already in April 2022, the "Frequently asked questions about parallel distribution" were revised and published on the EMA website - as already reported recently. Now, the Q&As have been updated again and supplemented.

The competent authority of Portugal (National Authority of Medicines and Health Products, I.P.) has entered a new GPD Non-Compliance Report into the EudraGMDP database. According to the authority, the wholesaler concerned does not comply wth the GDP principles of cold chain products.

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.

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.

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.

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.

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.