The Third Amendment of drug and other regulations of 7 August 2013 ( Federal Law Gazette . I S. 3108) Coming-Soonentered into force on 13 August 2013. This amendment brought extensive changes for the submission requirements for NIS (AWB) into effective. The BfArM and PEI joint recommendations on the implementation, planning and analysis of observational studies of 7 July 2010 therefore no longer reflect the current legal status again. The recommendations will be revised in the near future according to the new law. Until the publication of the updated recommendations, the previous recommendations for information remain available on this website (as per the BfArM Guidance on NIS).