EN
L 314/14
Official Journal of the European Union
6.12.2022
For the purposes of the studies referred to in the first subparagraph, the Centre shall also make use of other relevant data, for example on environmental and socio-economic factors. 3a.
The Centre may use its resources and make use of reference laboratories, in order to perform field research, data gathering and data analysis, for the purposes of helping relevant national bodies gather reliable data.’; (c) paragraph 4 is replaced by the following: ‘4.
The Centre shall consult with the HSC, the Commission and other relevant Union bodies or agencies with regard to the planning and priority setting of research and public health studies, taking into account the opinion of the Advisory Forum.’; (8)
Article 7 is replaced by the following: ‘Article 7 Procedure for scientific opinions 1.
The Centre shall issue a scientific opinion on matters falling within its mission:
(a) in all cases where Union legislation provides that the Centre is to be consulted; (b) at the request of the European Parliament or a Member State; (c) at the request of the Commission, the HSC or EMA; and (d) on its own initiative.
2. Requests for a scientific opinion as referred to in paragraph 1 shall clearly explain the scientific issue to be addressed and the Union interest concerned, and shall be accompanied by sufficient background information regarding that issue.
Where necessary, if scientific opinions are focused on a specific Member State, the Member State concerned shall have the opportunity to contribute with expertise. 3.
The Centre shall ensure that it has the ability to anticipate and react quickly in order to issue scientific opinions within a mutually agreed time frame.
The Centre’s scientific opinions shall be accessible and shall be operational for policy makers. 4.
Where different requests are made on the same issue or where the request does not comply with paragraph 2, the Centre may refuse to issue a scientific opinion or propose amendments to that request in consultation with the institution, committee, agency or Member State that made the request.
If the request is refused, the Centre shall provide the institution, committee, agency or Member State that made the request with the reasons for the refusal. 5.
Where the Centre has already delivered a scientific opinion on the specific issue covered by a request and it concludes that no scientific elements justify re-examination of the issue, information supporting that conclusion shall be given to the institution, committee, agency or Member State that made the request. 6.
The Centre’s internal rules shall specify requirements regarding the format, explanatory background and transparency rules for the publication of a scientific opinion.’; (9)
Article 8 is replaced by the following: ‘Article 8 Operation of the Early Warning and Response System 1.
The Centre shall support and assist the Commission by operating the EWRS in accordance with Article 18 of Regulation (EU) 2022/2371 and by ensuring, together with the Member States, the capacity to respond to health threats in a coordinated and timely manner.
2.
The Centre shall:
(a) analyse the content of messages it receives via the EWRS; (b) provide information, expertise, advice, training and risk assessments to Member States and the Commission; and (c) ensure that the EWRS is efficiently and effectively linked with other Union alert systems.