Clinical trials on medicinal products: European Commission Implementing Regulation on detailed arrangements for good clinical practice inspection procedures published in Official Journal
On 25 March 2017, European Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (E ...
Medicinal products: European Commission publishes Report on shortcomings in the summary of product characteristics and the package leaflet
On 22 March 2017, the European Commission published a Report in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to me ...
CLP regime: European Commission Regulation adding an Annex to CLP Regulation 2008 published in Official Journal
On 23 March 2017, European Commission Regulation (EU) 2017/542 amending Regulation (EC) 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances ...
ECHA maintains glyphosate classification
The European Chemicals Agency (ECHA) has agreed to maintain the current harmonised classification of glyphosate.
Drugs strategy: European Commission proposes new EU Action Plan on Drugs (2017-20)
On 15 March 2017, the European Commission proposed a new EU Action Plan on Drugs (2017-20). It follows the first EU Action Plan on Drugs (2013-16) and sets out the actions that will be implemented to ...
Official controls: European Parliament formally adopts Regulation at second reading
On 15 March 2017, the European Parliament plenary session formally adopted, at early second reading, the draft Regulation of the European Parliament and of the Council on official controls and other o ...
Food information to consumers: European Commission adopts Report of mandatory ingredient labelling on alcoholic beverages
On 13 March 2017, the European Commission adopted a Report on mandatory ingredient labelling in response to the obligation set for the Commission by Article 16(4) of Regulation (EU) 1169/2011 on the p ...
Drug strategy: European Commission adopts ex post Report on Drug Prevention and Information Programme (2007-13)
On 6 March 2017, the European Commission adopted its ex post Report on the Drug Prevention and Information Programme (2007-13).
FDA and EU Announce Mutual Recognition of cGMP Inspections (Multi-Jurisdictional)
The FDA and the European Medicines Agency announced that the US and EU will recognize each other's current good manufacturing practice (cGMP) inspections of pharmaceutical manufacturing facilities.
Council adopts draft medical device and IVD regulations (EU)
The Council of the EU publishes its position at first reading on the European Commission proposals for regulations on medical devices and in vitro diagnostic devices.
Cross-border health threats: European Commission Implementing Decision updating procedures for Early Warning and Response System published in Official Journal
On 14 February 2017, European Commission Implementing Decision (EU) 2017/253 of 13 February 2017 laying down procedures for the notification of alerts as part of the Early Warning and Response System ...
REACH: ECHA can publish authorisation documents on endocrine disruptors (General Court (EU))
The General Court (EU) gave its decision in Deza v ECHA  EUECJ T-189/14, 13 January 2017.
General Court dismisses European Dynamics appeal against EMA rejection of candidates under framework contract
On 17 February 2017, the General Court dismissed an appeal by the Greek company Evropaiki Dinamiki (European Dynamics) in relation to the rejection by the European Medicines Agency (EMA) of candidates ...
Air pollution: EU issues UK with reasoned opinion
The European Commission issued a reasoned opinion to the UK for its breaches of air pollution limits for nitrogen dioxide (NO2) under Directive 2008/50/EC of the European Parliament and of the Council ...
Health and safety at work: European Commission Directive establishing fourth list of indicative occupational exposure limit values published in Official Journal
European Commission Directive (EU) 2017/164 of 31 January 2017 establishing a fourth list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC was published in the O ...
Antimicrobial resistance: European Commission launches public consultation on possible activities under a One-Health Action Plan to fight against AMR
On 27 January 2017, the European Commission launched a public consultation on possible activities under a "Commission Communication on a One Health Action Plan to support member states in the fights a ...
Health Programme 2014-20: Annual Work Plan adopted by the European Commission and call for proposals to be launched shortly
On 26 January 2017, the European Commission adopted a Commission Implementing Decision concerning the Work Programme for 2017 in the framework of the third Programme of the EU's action in the field of ...
European Commission proposes amendments to Paediatric Regulation for EEA
The European Commission has proposed for a Council Decision some amendments to the Paediatric Regulation and to related provisions for the grant of supplementary protection certificates.
Human tissues and cells: European Commission launches evaluation of EU legislation on blood, tissues and cells
On 17 January 2017, the European Commission launched an evaluation of EU legislation in the area of blood, tissues and cells, with the aims of providing a comprehensive assessment of EU legislation in ...
European Citizens' Initiative: "Ban Glyphosate" Initiative registered
On 10 January 2017, the European Commission decided to register a European Citizens' Initiative (ECI), "Ban Glyphosate".
Health and safety at work: European Commission adopts Communication on modernisation of occupational health and safety and proposal to amend Carcinogens Directive
On 10 January 2017, the European Commission adopted a Communication on modernisation of occupational health and safety legislation and policy and a proposal to amend the Carcinogens Directive.
Pharmacologically active substances: European Commission Implementing Regulation regarding form and content of applications and requests for establishment of MRLs published in Official Journal
On 7 January 2017, European Commission Implementing Regulation (EU) 2017/12 regarding the form and content of the applications and requests for the establishment of maximum residue limits (MRLs) in ac ...
Human organs intended for transplantation: European Commission adopts Report on implementation of Directive 2010/53/EU
On 4 January 2017, the European Commission adopted a Report on the implementation of Directive 2010/53/EU of the European Parliament and of the Council on standards of quality and safety of human orga ...
Official controls: Council adopts first reading position on proposal
On 19 December 2016, the Environment Council adopted its first reading position on the European Commission proposal for a Regulation on official controls and other official activities performed to ens ...
Revised National Emission Ceilings Directive 2016 published in Official Journal
Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and r ...
Related legislation trackers
- Animal cloning and novel foods package: legislation trackers
- Carcinogens and Mutagens Directive: legislation tracker
- Cloning of animals: legislation tracker
- In vitro diagnostic medical devices: legislation tracker
- Medical devices: legislation tracker
- Medical devices: legislation trackers
- New psychoactive substances: legislation tracker
- Placing on market of food from animal clones: legislation tracker
- Restricting or prohibiting use of genetically modified food and feed: legislation tracker
Key ongoing EU legislative initiatives
A practice note presenting a selection of key ongoing EU legislative initiatives in this topic area that are currently going through the legislative procedure.