5 Amendments of Elżbieta Katarzyna ŁUKACIJEWSKA related to 2018/0018(COD)
Amendment 331 #
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
The joint clinical assessment report shall be accompanied by a summary report and they shall be prepared in accordance with the requirements in this Article and the requirements established pursuant to Articles 11, 22, and 23 assessment report should be publicly accessible without delay.
Amendment 354 #
Proposal for a regulation
Article 6 – paragraph 5 – introductory part
Article 6 – paragraph 5 – introductory part
5. The conclusions of the joint clinical assessment report shall be limited to the followcontaing:
Amendment 360 #
Proposal for a regulation
Article 6 – paragraph 5 – point a
Article 6 – paragraph 5 – point a
(a) an analysis of the relaspective effects of the health technology being assessed on the patient-relevant health outcomes chosen for the assessment;
Amendment 437 #
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
1a. Paragraph 1(b) shall not prevent Member States from carrying out assessments on the added clinical value of the technologies concerned as part of national or regional appraisal processes which may consider clinical as well as non-clinical data and evidence specific to the Member State concerned which did not form part of the joint clinical assessment and which are necessary to complete the general assessment of health technology, provided these additional requirements do not delay patient access to these technologies.
Amendment 463 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. The designated sub-group shall request the health technology developer to submit the documentation containing the information, data and evidence necessaryavailable and up to date documentation containing all stages of information processing, data and studies require for the joint scientific consultation.