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 April 2019
EMA Scientific guideline: Guideline on determination of withdrawal periods for edible tissues – Revision 1, adopted.
1st May 2019
EMA Scientific guideline: Guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease – First version, adopted.
1st June 2019
EMA Scientific guideline: VICH GL56 on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods – First version, adopted.
1st July 2019