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1. The Agency shall set up and manage a rapid European drug alert system, complementing and without prejudice to the relevant national alert systems. The European drug alert system shall be complementary to the early warning system referred to in Article 8.

2. The national focal points, in cooperation with the relevant national competent authorities, shall immediately notify the Agency of any information relating to the appearance of a serious direct or indirect drug-related risk to health, social aspects, safety or security and of any information that might be useful for coordinating a response whenever they become aware of such information, such as:

(a) the type and origin of the risk;

(b) the date and place of the event involving the risk;

(c) the means of exposure, transmission or dissemination;

(d) analytical and toxicological data;

(e) identification methods;

(f) health risks;

(g) social, safety and security risks;

(h) health measures implemented or intended to be taken at national level;

(i) measures other than health measures;

(j) any other information relevant to the serious risk to health in question.

3. The Agency shall analyse and assess the available information and data on potential serious risks to health and complement it with any scientific and technical information available from the early warning system referred to in Article 8 and other threat assessments undertaken in accordance with Article 12, from other Union bodies, offices and agencies and from international organisations, in particular the World Health Organization. The Agency shall take into account open source information and available information obtained through its data collection tools and from relevant stakeholders, including the scientific community and civil society organisations.

4. Based on the information and data received pursuant to paragraph 3, the Agency shall provide targeted rapid alert risk communications to the relevant national authorities, including the national focal points. The Agency may propose response options in such risk communications. Member States may consider such response options as part of their preparedness planning and national response activities.

5. The national focal points, in cooperation with the relevant national competent authorities, shall inform the Agency of additional information at their disposal in order to enable the Agency to further analyse and assess risks referred to in paragraph 2 and of the actions implemented or measures taken following receipt of the rapid alert risk communications referred to in paragraph 4.

6. The Agency shall cooperate closely with the Commission and the Member States to promote the necessary coherence in the risk communication process.

7. The Agency may open up participation in the European drug alert system to third countries or international organisations. That participation shall be based on reciprocity and shall include confidentiality measures equivalent to those applicable in the Agency.

8. In close cooperation with the relevant national competent authorities, in particular the national focal points, the Agency shall, if needed, develop an alert system to make information on a specific risk available, where appropriate, to people who use or potentially use specific drugs.

9. The Agency shall update its drug alerts, whenever necessary.