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6 Amendments of João FERREIRA related to 2018/0018(COD)

Amendment 24 #
João FERREIRA
Proposal for a regulation
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 11468 thereof,
2018/05/25
Committee: ITRE
Amendment 55 #
João FERREIRA
Proposal for a regulation
Article 1.º – paragraph 2 a (new)
2a. This regulation must aim to foster and strengthen national health systems by promoting measures for research into and the production and distribution of health technologies, with free, universal access.
2018/05/25
Committee: ITRE
Amendment 60 #
João FERREIRA
Proposal for a regulation
Article 3.º – paragraph 3
3. The Coordination Group shall act by consensus, or, where necessary, vote by simple majority. There shall be one vote per Member State.
2018/05/25
Committee: ITRE
Amendment 101 #
João FERREIRA
Proposal for a regulation
Article 10.º – paragraph 1 – point b – point ii
(ii) comment on the draft joint clinical assessment reports and summary reports;deleted
2018/05/25
Committee: ITRE
Amendment 148 #
João FERREIRA
Proposal for a regulation
Article 34.º – paragraph 1
1. Member States may carry out a clinical assessment using means other than the rules provided for in Chapter III of this Regulation, on grounds related to the need to protect public health in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim.
2018/05/25
Committee: ITRE
Amendment 149 #
João FERREIRA
Proposal for a regulation
Article 34.º – paragraph 3
3. The Commission shall, within three months of the date of receiving the notification provided for in paragraph 2, approve or reject the planned assessment after having verified whether or not it complies with the requirements referred to in paragraph 1 and whether or not it is a means of arbitrary discrimination or a disguised restriction on trade between Member States. In the absence of a decision by the Commission by the end of the three month period, the planned clinical assessment shall be deemed to be approved.deleted
2018/05/25
Committee: ITRE
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