Changes from plenary report to adopted text

Added7. The HERA Board shall adopt its rules of procedure, including regarding the election of a co-Chair and voting procedures.

Added8. The list of members and alternates, and the rules of procedure of the HERA Board, as well as the agendas and minutes of its meetings shall be made available on the Authority’s website.

AddedArticle 17b Tasks of the HERA Board

AddedThe HERA Board shall:

Added(a) adopt the multiannual strategic planning for HERA;

Added(b) adopt strategic decisions concerning HERA on research and innovation and industrial strategy in the area of antimicrobials and medical countermeasures;

Added(c) adopt a long-term European portfolio of research and development projects in line with public health priorities set by the Commission in consultation with the WHO;

Added(d) ensure scientific and technical management of HERA;

Added(e) assess the performance of the tasks entrusted to HERA;

Added(f) contribute to the coherence of the Union’s crisis preparedness and response management;

Added(g) contribute to the coordinated action by the Commission and the Member States for the implementation of Regulation (EU) 2022/2371;

Added(h) contribute to the implementation of the Union’s Global Health Strategy, in particular in relation to addressing current and emerging health threats;

Added(i) adopt opinions and guidance, including on specific response measures for the Member States for the prevention and control of serious cross-border threats to health, including antimicrobial resistance;

Added(j) adopt proposals for the annual budget of HERA and the monitoring of its implementation.’ [Am. 359]

Added(5) Article 19 is replaced by the following:

Added‘Article 19 Transparency and conflicts of interest

Added1. Members of the Management Board, members of the HERA Board, members of the scientific panels, members of the Advisory Forum, the director and the staff shall undertake to act in the public interest and in an independent manner. They shall not have any direct or indirect financial or other interests in the pharmaceutical or other medical industry which could affect their impartiality. They shall make an annual declaration of their financial interests and update them annually and whenever necessary. The declaration shall be made available upon request.

Added2. The ECDC's and Authority’s code of conduct shall provide for the implementation of this Article.

Added3. The ECDC and the Authority shall make available the rules of procedure, meeting agendas and minutes, and the members of the structures referred to in paragraph 1 and their declarations of interest on their website.

Added4. Stakeholders invited to meetings at the ECDC and the Authority shall declare their interests ahead of the meeting.’ [Am. 360]

AddedArticle 176 Amendments to Regulation (EC) No 1394/2007

AddedRegulation (EC) No 1394/2007 is amended as follows:

Added(1) Articles 8, 17 and 20 to 23 are deleted;

Added(2) in Article 9(3), the fourth subparagraph is replaced by the following:

Added‘If the application does not include the results of the assessment, the Agency shall seek an opinion on the conformity of the device part with Annex I to Regulation (EU) 2017/745 of the European Parliament and of the Council* from a notified body identified in conjunction with the applicant, unless the Committee for Medicinal Products for Human Use advised by its experts for medical devices decides that involvement of a notified body is not required.

Added*Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).’

AddedArticle 177 Amendments to Regulation (EU) No 536/2014

AddedRegulation (EU) No 536/2014 is amended as follows:

Added(1) the following Article 5a is inserted:

Added‘Article 5a

AddedEnvironmental risk assessment for investigational medicinal products for human use containing or consisting of genetically modified organisms

Added1. Where the application according to Article 5 of this Regulation concerns clinical trials with investigational medicinal products for human use containing or consisting of genetically modified organisms (GMOs) within the meaning of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council*, the sponsor shall submit an environmental risk assessment (ERA) in the EU portal (CTIS).

Added2. The ERA referred to in paragraph 1 shall be conducted in accordance with the principles set out in Annex II to Directive 2001/18/EC and the scientific guidelines developed by the Agency in coordination with the competent authorities of the Member States, established according to Directive 2001/18/EC for this purpose and the delegated act referred to in paragraph 8.

Added3. Articles 6 to 11 of Directive 2001/18/EC shall not apply to investigational medicinal products for human use containing or consisting of genetically modified organisms.

Added4. The Committee for Medicinal Products for Human Use (CHMP) shall assess the ERA referred to in paragraph 1 in the form of a scientific opinion. The CHMP shall submit its opinion to the competent authority of the Reporting Member State within 45 days from the validation date referred to in Article 5(3). Where appropriate, the opinion shall include risk mitigation measures. The sponsor shall provide evidence to the Reporting Member State and the Member States Concerned that these measures will be implemented.

Added5. The CHMP may request, with justified reasons, via the EU portal (CTIS) additional information from the sponsor regarding the assessment referred to in paragraph 1, which shall be provided only within the period referred to in paragraph 5.

Added6. To obtain and review the additional information referred to in paragraph 6, the Agency may extend the period referred to in paragraph 5 by a maximum of 31 days. The sponsor shall submit the requested additional information within the period set by the Agency. Where the sponsor does not provide additional information within the period set by the Agency, the application referred to in paragraph 1 shall be deemed to have expired in all Member States concerned.

Added7. In case of first-in-class products or when a novel question arises during the assessment of the submitted ERA as referred to in paragraph 1, the Agency shall consult with bodies that Member States have set up in accordance with Directive 2001/18/EC or Directive 2009/41/EC of the European Parliament and of the Council**. If a consultation is necessary, the technical dossier addressing in sufficient detail the information specified in Annex III to Directive 2001/18/EC should be included to support the ERA where appropriate.

Added8. The Commission shall be empowered to adopt a delegated act in accordance with Article 89 to amend the Annexes to this Regulation in order to specify the procedure for the submission and the harmonized assessment of the ERA for investigational medicinal products containing or consisting of GMOs as set out in paragraphs 1 to 8.

AddedThe delegated act referred to in the first subparagraph shall establish that the ERA is an independent part of the application.

AddedThe delegated act referred to in the first subparagraph shall specify the content of the ERA taking into account the common application forms and Good Practice Documents for genetically modified human cells and for adeno-associated viral vectors that were published by the Agency.

AddedThe delegated act referred to in the first subparagraph shall contain a provision to update the ERA requirements for investigational medicinal products containing or consisting of GMOs following scientific developments and changes of (Directive 2001/18/EC).’;

Added* Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC - Commission Declaration (OJ L 106, 17.4.2001, p. 1).

Added** Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (OJ L 125, 21.5.2009, p. 75).’;’

Added(2) in Article 25(1), point (d), is replaced by the following:

Added‘(d) measures to protect subjects, third persons and the environment;;’

Added(3) Article 26 is replaced by the following:

Added‘Article 26

AddedLanguage requirements

AddedThe language of the application dossier, or parts thereof, shall be determined by the Member State concerned.

AddedThe language for the environmental risk assessment (ERA) shall preferably be English.

AddedMember States, in applying the first subparagraph, shall consider accepting, for the documentation not addressed to the subject, a commonly understood language in the medical field.;’

Added(4) in Article 37(4), the following subparagraph is inserted after the first subparagraph:

Added‘In the case of a clinical trial which involves the use of a medicinal product in the paediatric population, the timeline referred to in the first subparagraph to submit to the EU database a summary of the results of the clinical trial shall be 6 months.’;’

Added(5) in Article 61(2), point (a), is replaced by the following:

Added‘(a) it shall have at its disposal, for manufacture or import, suitable and sufficient premises, technical equipment and control facilities complying with the requirements set out in this Regulation and, where appropriate, in case of investigational medicinal products containing or consisting of GMOs, in Directive 2009/41/EC;;’

Added(6) in Article 66(1), point (c), is replaced by the following:

Added‘c) information to identify the medicinal product, including, where appropriate, ‘This IMP contains genetically modified organisms;’;’

Added(7) in Article 76, paragraph (1) is replaced by the following:

Added‘1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from the participation in a clinical trial or caused to third persons or the environment during such trial conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk.;’