The terms regarding Windsor Framework that you need to know are here: EMVS European Medicines Verification System PL A product licensed by the MHRA that covers the whole of the UK, coming into effect from 1 January 2025 UK-wide Marketing Authorization (MA) A product licensed by the MHRA, across the whole...
Read More
All terms regarding the regulatory harmonization in Africa that you need to know AMA African Medicines Agency ย AMRH African Medicines Regulatory Harmonization. The initiative that provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa ย AU African Union. It comprises five regions and has 55 members:...
Read More
All terms regarding DSCSA that you need to know are here: ADR Authorized Distributor of Record. A wholesale distributor that a manufacturer designates or authorizes to distribute its products. ASN Advanced Ship Notice. A notification of pending deliveries, usually in an electronic format. ASN is the common name for...
Read More
SoftGroup prepared a set with the core terminology regarding the EU MDR and IVDR you should known navigating the new regulation demands, terms, and acronyms. The European Union (EU) is approaching its deadline to implement the Medical Device Regulation (EU MDR). As the transition period ends...
Read More
All terms regarding serialization that you need to know are here: 3PLโThird-Party Logistics. A contracted company that provides distribution services of finished goods on behalf of another company. A 3PL never takes ownership of the product although the product is in its possession. AggregationโThe process of recording...
Read More