33 Amendments of Edite ESTRELA related to 2012/0192(COD)
Amendment 199 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – introductory part
Article 2 – paragraph 2 – point 3 – introductory part
(3) ‘Low-intervention clinical trialstudy’: a clinical trial which fulfils all of the following conditions: (Horizontal amendment applying throughout the text. Adopting it will necessitate corresponding changes.)
Amendment 209 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point b
Article 2 – paragraph 2 – point 3 – point b
(b) according to the protocol of the clinical trial, the investigational medicinal products are used in accordance with the terms of the marketing authorisation or their use is a standard treatment in any ofin the Member States concerned;
Amendment 215 #
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘Non-interventional study’: a clinical study other than a clinical trial and a low interventional clinical trial as defined in Article 2, second paragraph, points (2) and (3), respectively;
Amendment 218 #
Proposal for a regulation
Article 2 – paragraph 2 – point 6
Article 2 – paragraph 2 – point 6
(6) ‘Normal clinical practice’Best current proven intervention': the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder; in accordance with the current reliable scientific evidence; (Horizontal amendment applying throughout the text. Adopting it will necessitate corresponding changes.)
Amendment 261 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
Amendment 263 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 268 #
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within sixfifteen days following submission of the application dossier, the proposed reportingappointment, this Member State shall notify the sponsor through the EU portal of the following:
Amendment 274 #
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where the proposed reporting Member State has not notified the sponsor within the time period referred to in paragraph 2, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, and the clinical trial shall be considered a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 281 #
Proposal for a regulation
Article 5 – paragraph 4 – subparagraph 3
Article 5 – paragraph 4 – subparagraph 3
Where the proposed reporting Member State has not notified the sponsor according to points (a) to (d) of paragraph 2 within threfive days following receipt of the comments or of the completed application, the application shall be considered complete, the clinical trial shall be considered as falling within the scope of this Regulation, the clinical trial shall be considered as a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 309 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – introductory part
Article 6 – paragraph 4 – subparagraph 1 – introductory part
4. The reporting Member State shall submit Part I of the assessment report, including its conclusion, already comprising the views of the concerned Ethics Committee, to the sponsor and to the other Member States concerned within the following time periods:
Amendment 311 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 120 days from the validation date for low-intervention clinical trials;
Amendment 314 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 235 days from the validation date for clinical trials other than low- intervention clinical trials;
Amendment 318 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
(c) within 3045 days from the validation date for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 320 #
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Until the assessment date, any Member State concerned may communicate to the reporting Member State any considerations relevant to the application. The reporting Member State shall take those considerations duly into account and shall document them in the assessment report. If the assessment report of the reporting Member State deviates from the considerations of the Member States concerned, the reasons for such deviation shall be stated in the assessment report.
Amendment 341 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Each Member State concerned shall complete its assessment within twenty days from the validation date. It may request, with justified reasons, additional explanations from the sponsor regarding the aspects referred to in paragraph 1 only within that time period.
Amendment 349 #
Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 2
Article 8 – paragraph 1 – subparagraph 2
Notification shall be done by way of one single decision already comprising the views of the concerned Ethics Committee, within ten days from the assessment date or the last day of the assessment referred to in Article 7, whichever is later.
Amendment 363 #
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. Wherith regard to low-intervention clinical trials, in case the Member State concerned has not notified the sponsor of its decision within the time periods referred to in paragraph 1, the conclusion on Part I of the assessment report shall be considered as the decision of the Member State concerned on the application for authorisation of the clinical trial, provided that it was considered a low-intervention clinical trial in accordance with Article 5 (2).
Amendment 374 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. In addition, the views of the concerned Ethics Committee shall be taken into account.
Amendment 389 #
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
Where the sponsor so requests, the application for authorisation of a clinical trial, its assessment and the decision shall be limited to the aspects covered by Part I of the assessment report.
Amendment 390 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
After the notification of the decision on the aspects covered by Part I of the assessment report, the sponsor mayshall apply for an authorisation limited to aspects covered by Part II of the assessment report. In this case, that application shall be assessed in accordance with Article 7 and the Member State concerned shall notify its decision with regard to Part II of the assessment report in accordance with Article 8. Failure in granting approval on either Part I or II of the application file shall result in refusal of the authorization of the clinical trial.
Amendment 392 #
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
This Chapter is without prejudice to the possibility for the sponsor to submit, following the refusal to grant an authorisation or the withdrawal of an application, an application for authorisation to any intended Member State concerned. That application shall be considered as a newresubmission of the application for authorisation of another clinical trial. It shall be accompanied by any previous assessment report, by the considerations of the concerned Members States, and it shall highlight the changes or the reasons justifying the resubmission of the application dossier.
Amendment 400 #
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 2 – point b a (new)
Article 14 – paragraph 4 – subparagraph 2 – point b a (new)
(ba) refusal by the Ethics Committee to approve the conduct of the clinical trial.
Amendment 411 #
Proposal for a regulation
Article 17 – paragraph 2 – introductory part
Article 17 – paragraph 2 – introductory part
2. Within fourten days following submission of the application dossier, the reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 420 #
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 2
Article 19 – paragraph 1 – subparagraph 2
Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within tfifteen days from the assessment date.
Amendment 421 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 2 – point b a (new)
Article 19 – paragraph 2 – subparagraph 2 – point b a (new)
(ba) refusal by the Ethics Committee to approve the conduct of the clinical trial.
Amendment 426 #
Proposal for a regulation
Article 20 – paragraph 5 – subparagraph 2
Article 20 – paragraph 5 – subparagraph 2
Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within tfifteen days from the validation date.
Amendment 427 #
Proposal for a regulation
Article 20 – paragraph 7
Article 20 – paragraph 7
7. Wherith regard to low-intervention clinical trials, in case the Member State concerned has not notified the sponsor of its decision within the time periods set out in paragraphs 5 and 6, the substantial modification shall be considered as authorised, provided that it was considered a low-intervention clinical trial in accordance with Article 5 (2).
Amendment 430 #
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. Each Member State concerned shall assess, for its territory, the aspects of the substantial modification which are covered by Part II of the assessment report within tfifteen days from the validation date, according to the procedure referred to in Article 7, paragraph 1.
Amendment 432 #
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 2
Article 23 – paragraph 1 – subparagraph 2
Notification shall be done by way of one single decision, already comprising the views of the concerned Ethics Committee, within tfifteen days from the assessment date or the last day of the assessment referred to in Article 22, whichever is later.
Amendment 434 #
Proposal for a regulation
Article 23 – paragraph 2 – subparagraph 2 – point b a (new)
Article 23 – paragraph 2 – subparagraph 2 – point b a (new)
(ba) refusal by the Ethics Committee to approve the substantial modification of the clinical trial.
Amendment 435 #
Proposal for a regulation
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Wherith regard to low-intervention clinical trials, in case the Member State concerned has not notified the sponsor of its decision within the time periods referred to in paragraph 1, the conclusion on the substantial modification of aspects covered by Part I of the assessment report shall be considered as the decision of the Member State concerned on the application for authorisation of the substantial modification. , provided that it remains a low-intervention clinical trial in accordance with Article 5 (2).
Amendment 530 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
3. Within one year from the end of a clinical trial, the sponsor shall submit to the EU database a summary of the results of the clinical trial, the clinical study report (CSR) and the full dataset of clinical trial data. These elements shall be made publicly accessible through the EU database.
Amendment 602 #
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
Unless other Union legislation requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file for at least fivetwenty years after the end of the clinical trial. However, the medical files of subjects shall be archived in accordance with national legislation.