On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
IMPLICATIONS OF THE EUROPEAN PARLIAMENT ELECTIONS ON DRAFT LEGISLATIVE PROPOSALS
Unfinished business lapses
The European Parliament (“EP”) undertakes its formal decision making on legislative proposals during its plenary sessions. Rule 214 of Rules of Procedure of the European Parliament ("EP RoP") states that, at the end of the last EP plenary session, which this year is scheduled to take place between 14 and 17 April 2014, the EP's unfinished business shall be deemed to have lapsed.
However, at the beginning of the new Parliamentary term in May 2014, the Conference of Presidents ("CoP"), which consists of the President of the EP and the leaders of the political parties represented in Parliament, may take a decision on whether to resume or continue the consideration of unfinished legislative proposals. These decisions are taken following a reasoned request from the Parliamentary Committees and other EU Institutions. Non-legislative petitions and communications do not require such decisions.
Therefore, if the Conference of Presidents decides, following a request from the EP, European Commission or Council of the European Union, that the consideration of a proposal should be resumed, then the Parliamentary Committees and the EP may continue to work and deliberate on the legislative proposal.
At the beginning of the current Parliamentary term in September 2009, the EP undertook a complete analysis of over 200 pending dossiers from the 6th Parliamentary term which had not yet been completed. These dossiers also included various legislative proposals. On the basis of this analysis by the Parliamentary Committees, the EP, in applying Rule 214, decided to resume review of a large number of legislative proposals from the previous Parliamentary term. However, the EP also decided not to resume review of 10 of the pending legislative proposals. These proposals were sent back to the Commission with a view to their withdrawal or replacement.
Under Rule 59 of the EP RoP, a proposal may be referred back to the EP for consideration a second time if elections have taken place since the EP adopted its original position. The Parliamentary Committees, political groups or 40 of the MEP's can request that the European Commission or the Council of the European Union refer the proposal back to the EP. For all requests, the CoP must also consider it desirable to refer the proposal back to the EP.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017