P8_TA(2018)0420 Authorisation and supervision of medicinal products for human and veterinary use ***I European Parliament legislative resolution of 25 October 2018 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (COM(2014)0557 — C8-0142/2014 — 2014/0256(COD)) P8_TC1-COD(2014)0256 Position of the European Parliament adopted at first reading on 25 October 2018 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use
Date: 2018-10-25
Institutions: Committee on Agriculture and Rural Development, Committee on Industry, Research and Energy, Committee on the Environment, Climate and Food Safety, Committee on the Internal Market and Consumer Protection, European Parliament
Subjects: European Medicines Agency, drug surveillance, health control, market approval, marketing standard, medicinal product, veterinary inspection, veterinary medicinal product








C_2020345EN.01033401.xml










16.10.2020   


EN


Official Journal of the European Union


C 345/334






P8_TA(2018)0420
Authorisation and supervision of medicinal products for human and veterinary use ***I
European Parliament legislative resolution of 25 October 2018 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (COM(2014)0557 — C8-0142/2014 — 2014/0256(COD))
(Ordinary legislative procedure: first reading)
(2020/C 345/46)

The European Parliament,






—


having regard to the Commission proposal to Parliament and the Council (COM(2014)0557),










—


having regard to Article 294(2) and Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0142/2014),










—


having regard to Article 294(3) of the Treaty on the Functioning of the European Union,










—


having regard to the opinion of the European Economic and Social Committee of 21 January 2015 (1),










—


after consulting the Committee of the Regions,










—


having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 13 June 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,










—


having regard to Rule 59 of its Rules of Procedure,










—


having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on the Agriculture and Rural Development (A8-0035/2016),












1.


Adopts its position at first reading hereinafter set out (2);












2.


Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;












3.


Instructs its President to forward its position to the Council, the Commission and the national parliaments.






(1)  OJ C 242, 23.7.2015, p. 39..

(2)  This position replaces the amendments adopted on 10 March 2016 (Texts adopted, P8_TA(2016)0088).




P8_TC1-COD(2014)0256
Position of the European Parliament adopted at first reading on 25 October 2018 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2019/5.)