[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In mid-May, the EMA’s GMP/GDP Inspectors Working Group (IWG) released a concept paper on providing additional guidance on the GMP requirements that are of particular relevance to importers and on the extent those requirements apply to the different entities involved in importation activities. The IWG foresees that the guidance would take the form of a new annex to the EU GMPs, which would be annex 21. The deadline for comments is August 29. A harmonized approach to import testing and to interpreting the term “import” are among the goals.