CELEX 02008R1272 · v20250901

Article 45 / Appointment of bodies responsible for receiving information relating to emergency health response

Article 45

Appointment of bodies responsible for receiving information relating to emergency health response

▼M36

1.  
Member States shall appoint a body or bodies responsible for receiving the relevant harmonised information relating to emergency health response and preventative measures, in accordance with Annex VIII.

▼B

2.  

The appointed bodies shall provide all requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used:

(a) 

to meet medical demand by formulating preventative and curative measures, in particular in the event of an emergency;

and

▼M36

(b) 

where requested by the Member State, the Commission or the Agency, to undertake a statistical analysis to identify where improved risk management measures may be needed.

▼B

The information shall not be used for other purposes.

3.  
The appointed bodies shall have at their disposal all the information required from the importers and downstream users responsible for marketing to carry out the tasks for which they are responsible.

▼M20

4.  
The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Annex VIII to further harmonise the information relating to emergency health response and preventative measures, following consultation with relevant stakeholders such as the European Association of Poison Centres and Clinical Toxicologists (EAPCCT).

▼B

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