P8_TA(2019)0401 Supplementary protection certificate for medicinal products ***I European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (COM(2018)0317 — C8-0217/2018 — 2018/0161(COD)) P8_TC1-COD(2018)0161 Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products
Date: 2019-04-17
Institutions: Committee on Industry, Research and Energy, Committee on International Trade, Committee on Legal Affairs, Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: administrative formalities, export (EU), market approval, medicinal product, pharmaceutical legislation, public health, single market








C_2021158EN.01034701.xml










30.4.2021   


EN


Official Journal of the European Union


C 158/347






P8_TA(2019)0401
Supplementary protection certificate for medicinal products ***I
European Parliament legislative resolution of 17 April 2019 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (COM(2018)0317 — C8-0217/2018 — 2018/0161(COD))
(Ordinary legislative procedure: first reading)
(2021/C 158/48)

The European Parliament,






—


having regard to the Commission proposal to Parliament and the Council (COM(2018)0317),










—


having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0217/2018),










—


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 19 September 2018 (1),










—


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 20 February 2019 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 Legal Affairs and also the opinions of the Committee on International Trade and the Committee on the Environment, Public Health and Food Safety (A8-0039/2019),












1.


Adopts its position at first reading hereinafter set out;












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 440, 6.12.2018, p. 100.




P8_TC1-COD(2018)0161
Position of the European Parliament adopted at first reading on 17 April 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2019/933.)