1st November 2018
EMA Scientific guideline: Guideline on user safety of topically administered veterinary medicinal products, adopted.
16th November 2018
EMA Scientific guideline: ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals – questions and answers – Step 5, adopted.
26th December 2018
1st January 2019
EMA Scientific guideline: Annex to Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues – Guideline on similar medicinal products containing somatropin – Rev. 1, adopted.
1st February 2019
EMA Scientific guideline: Guideline on core summary for product characteristics for human albumin solution – Revision 3, adopted.
9th February 2019
Commission Delegated Regulation EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use.
1st June 2019