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Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (notified under document C(2018) 7334)
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The RAPEX Contact Point is responsible for the submission of follow-up notifications via the RAPEX application. (See Part II, Chapter 5.1).
The Commission checks all follow-up notifications received through the RAPEX application before they are validated and transmitted to the Member States. These checks focus on the correctness and completeness of the information provided.
The Commission checks if a follow-up notification meets all the relevant requirements set out in the GPSD and in these Guidelines and if the correct procedure was applied. Once the correctness of a follow-up notification is confirmed, the Commission checks its completeness. Chapter 4.2.2 of these Guidelines is to be used as a point of reference for this examination.
The Commission pays special attention to follow-up notifications containing risk assessments. It verifies, in particular, that the risk description is complete, clearly presented and well documented, and that the risk assessment clearly relates to the product covered by a notification.
Before validating a follow-up notification, the Commission may request the reacting Member State to provide additional information or clarification within a given deadline. Validation of a follow-up notification may be conditional upon receipt of the data requested.
The Commission may request the opinion of any Member State and, in particular, the notifying Member State on a validated follow-up notification. The Member State submits its opinion to the Commission within a deadline specified by the latter. Furthermore, the notifying Member State informs the Commission whether any changes to the notification (e.g. to the risk assessment) or to its status (e.g. permanent withdrawal from the system) are necessary.
All follow-up notifications assessed as correct and complete are validated and distributed by the Commission according to the deadlines specified in Appendix 5 to these Guidelines.
The Commission does not validate follow-up notifications with a risk assessment different from that of the notification they refer to, if the risk assessment is not complete, clearly presented and well documented, or if it is not shown that the risk assessment was performed in relation to the product covered by the notification.
Follow-up notifications distributed through the RAPEX application are kept in the system as long as the notification to which they are attached. The Commission may permanently withdraw a validated follow-up notification from the RAPEX application if a notification to which this follow-up notification is attached has been withdrawn from RAPEX (in accordance with Part II, Chapter 3.4.7.1.1 of these Guidelines). Furthermore, the Commission may withdraw a validated follow-up notification where it clearly provides incorrect information, and in particular where:
the product found on the market by the reacting Member State is different from the product covered by the notification;
the measures adopted by the reacting Member State are successfully challenged in court or in other proceedings and subsequently withdrawn;
the risk assessment performed by the reacting Member State is proven to be incorrect or relates to a different product from the one covered by the notification.
The provisions of Chapters 3.4.7.1.2 and 3.4.7.1.3 apply.
Once the Commission decides to withdraw a follow-up notification it is removed from RAPEX (or otherwise made invisible to users of the system).
The Commission informs all Member States of the withdrawal of a follow-up notification via the online collaborative space referred to in Part II, Chapter 5.3.2 or through other equally effective means.
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