1st April 2017
EMA Scientific guideline: Guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use, adopted.
1st May 2017
EMA Scientific guideline: Guideline on requirements for the production and control of immunological veterinary medicinal products, adopted.
21st May 2017
1st June 2017
EMA Scientific guideline: Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight-heparins, adopted.
14th June 2017
EMA Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q3C (R5) on impurities: guideline for residual solvents – Step 5, adopted.
1st July 2017
EMA Scientific guideline: Guideline on the clinical development of medicinal products intended for the treatment of pain – First version, adopted.
1st August 2017
EMA Scientific guideline: Guideline on the conduct of efficacy studies for intramammary products for use in cattle, adopted.
1st November 2017
EMA Scientific guideline: VICH GL54 studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD), 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.