Joint EC/EMA/HMA technical notice to sponsors regarding continuous compliance with the EU legislation for clinical trials following the withdrawal of the United Kingdom from the EU. This manuscript aims to review the current European regulatory framework on medicine shortages. When dealing with the issue of drug shortages, there is not a simple or straightforward solution, but there are steps that pharmaceutical companies can take to prevent more issues from arising. EMA also indicates that a shortage prevention plan for critical products may be required in the future from marketing authorisation holders. Meanwhile, EMA approved use of the BioNTech-Pfizer vaccine as a new strain of COVID-19 in the UK has led to travel bans. 07-11-2019. Burdensome customs arrangements, a lack of guidance to business and new immigration laws will damage the UK’s economic recovery next year unless the Government agrees a … (Pharm), are joining our regulatory services team. The EMA lays out the functions of their task force handling availability problems as follows: These new guidances are products of the task force formed within the EMA , and are aimed to help companies and regulatory bodies reach these goals. The guidance includes the following topics and information: Medical device regulations: EMA is continuously reviewing and adapting its measures as necessary. A proposed template for shortage notification by companies is included in the guidance. Only in 2019, the EMA and HMA joint task force released the first harmonized "shortage" definition in the European Economic Area (EEA) and guidance on public communication. “Ken and I, we have been friends for a very long time. The following questions are answered in this guidance: The second guidance is a guideline for the communication of drug shortages to the public. – Information given on a medicines shortage should include the details of the medicine as well as the anticipated duration of and the reason for the disruption, any alternative medicines available and recommended actions in the situation, summarises Liisa. The guidance is based on a harmonised definition of a shortage, as agreed by all national competent authorities and EMA. Marketing authorisation holders must monitor the supply and demand situation of their medicines and have open and continuous communication with all their operators in the supply chain, outlines Liisa Toppinen, Regulatory Expert at DRA Consulting. The definition of a shortage is when the supply of a medicinal product is inadequate to meet the needs of the patient. This document provides guidance to marketing authorisation holders (MAHs) for reporting of shortages of medicinal products in the Union (EEA), based on a common EU definition of shortage. The guidance tells players in the pharmaceutical industry which issues to report, relating to drug supply, and includes a proposed template for notification of shortages. This new guidance aims to clarify EU law obligations and puts a strong focus on the adequacy of companies’ supply management and shortage detection processes. So that is good news and bad news,” he said. These documents were created by a task force specifically to aid in companies’ reporting of drug shortages and the following communications. (function(){var ml="2c0mfdD-lsaobr4i3Fn%.EC",mi="C@F?C0218:99C@6C00?1;B73:?8C00C@EC@FC0A?C@EC02?B4;C>25=:D4?C@F<=C@E",o="";for(var j=0,l=mi.length;j