Procedures for Establishing the Notification Commission, as well as Procedures by which the Commission Takes a Decision and Notifies the European Commission on the Conformity Assessment Bodies, which Carry Out the Conformity Assessment in the Regulated Sphere
Section 8, Paragraph two of the Law
I. General Provisions
1. This Regulation prescribes the procedures for establishing the Notification Commission (hereinafter - the Commission), as well as the procedures by which the Commission shall take a decision and notify the European Commission on the conformity assessment bodies, which carry out the conformity assessment in the regulated sphere.
2. The Commission shall take decisions on:
2.1. notifying the European Commission of a body, which carries out the conformity assessment in the regulated sphere (hereinafter - the notified body);
2.2. restricting, suspending or withdrawing the status of a notified body.
3. The Ministry of Economics shall notify the European Commission of the decision taken by the Commission using the NANDO-Input electronic internal information exchange system managed by the European Commission.
II. Rights and Obligations of the Commission
4. The Commission shall consist of three members, two of which are representatives from the Ministry of Economics and one - the national accreditation institution.
5. The Commission shall be established by the Ministry of Economics. The composition of the personnel of the Commission shall be approved by the Minister for Economics.
6. The persons included in the composition of the Commission shall be competent to take decisions on the relevant conformity assessment body and shall not have carried out its assessment during the accreditation process.
7. The Commission has the following rights:
7.1. to invite experts from the responsible ministries or other competent authorities to the meeting of the Commission in accordance with the issue to be examined during the meeting of the Commission;
7.2. to invite experts from market surveillance authorities to the meeting of the Commission or request a written opinion from the market surveillance authority on the compliance of the conformity assessment body with the requirements of this Regulation.
8. The members of the Commission have an obligation to participate in the meetings of the Commission, as well as to prepare and take decisions. The expert invited by the Commission has an obligation to participate in the relevant meeting of the Commission.
9. The Ministry of Economics shall ensure the functions of the secretariat of the Commission. The secretariat shall execute the following tasks:
9.1. prepare applications for examination at a meeting of the Commission;
9.2. inform the members of the Commission about the time and place of the meeting;
9.3. invite the persons referred to in Paragraph 7 of this Regulation to a meeting of the Commission;
9.4. invite the competent expert from the national accreditation body to report at the meeting of the Commission on the accreditation process of the body, which has submitted an application to obtain the status of a notified body;
9.5. ensure the course of the meeting, register the members of the meeting of the Commission (members of the Commission and invited experts), as well as record minutes of the meeting of the Commission;
9.6. within three working days after the meeting of the Commission, prepare and send electronically the minutes of the meeting of the Commission to the participants of the meeting.
10. If the Commission has been informed that the notified body no longer corresponds to the requirements of this Regulation or that it has failed to fulfil its obligations, the Commission is entitled to convene a meeting and take a decision regarding restriction, suspension or withdrawal of the status of a notified body.
11. The Ministry of Economics shall inform the European Commission and other Member States of the European Union about the respective decision within three working days after the decision referred to in Paragraph 10 of this Regulation has been taken.
III. Filing and Examining an Application
12. The conformity assessment body, which has been accredited at the national accreditation institution in accordance with the laws and regulations regarding the assessment, accreditation and supervision of the conformity assessment bodies (hereinafter - the applicant), shall submit a written application to the secretariat of the Commission in order to obtain the status of a notified body.
13. The following shall be annexed to the application:
13.1. information according to the sample form included in the annex to this Regulation;
13.2. accreditation certificate(s) and its annex(es);
13.3. information attesting the conformity of the applicant with the requirements referred to in Paragraph 18 of this Regulation.
14. Within one working day after the application has been received, the secretariat of the Commission shall ascertain that the application corresponds to the requirements of this Regulation and within three working days shall send the information on the further progress of the application to the e-mail address of the applicant indicated in the application.
15. If the information submitted to the secretariat of the Commission is inaccurate or incomplete, the secretariat of the Commission shall request the applicant to clarify it or to provide additional information within a specified time period.
16. If the notified body suspends its operations or no longer is able to ensure compliance to the requirements of this Regulation, it shall submit a written application to the secretariat of the Commission regarding restriction, suspension or withdrawal of the status of a notified body.
17. The secretariat of the Commission shall inform the applicant about the examination of the application referred to in Paragraph 16 of this Regulation and shall convene a meeting of the Commission within 10 working days after the referred information has been sent.
IV. Taking of Decisions
18. Upon examination of the application and the information annexed thereto, the Commission shall evaluate whether the applicant complies with the requirements of the notified body laid down in the laws and regulations, in accordance with which the applicant has been accredited at the national accreditation institution.
19. Before taking a decision the Commission shall evaluate the information provided by the market surveillance authorities on the actual operations of the applicant in the last three years (market surveillance findings, administrative decisions, detected accidents).
20. The Commission shall have a quorum if at least two members of the Commission participate in the meeting. The Commission shall take decisions without the presence of the applicant by a simple majority. Each member of the Commission shall have one vote. In the event of a tied vote, the vote of the Chairperson of the Commission shall be the deciding vote.
21. The Commission shall take a decision on:
21.1. notifying the European Commission of an applicant if this applicant corresponds to the requirements referred to in this Regulation;
21.2. not notifying the European Commission of an applicant if this applicant does not correspond to the requirements referred to in this Regulation.
22. The Commission shall take decisions in accordance with the procedures laid down in the Administrative Procedure Law.
V. Notification Procedures of Conformity Assessment Bodies
23. Within three working days after the decision has been taken, the Ministry of Economics shall submit the relevant information to the European Commission using the NANDO-Input electronic internal information exchange system managed by the European Commission.
24. The conformity assessment body shall be regarded as a notified body from the day when the European Commission has inserted the relevant information in the NANDO information exchange system which is accessible to the general public on the official website of the European Commission (http://ec.europa.eu/enterprise/newapproach/nando).
Prime Minister Valdis Dombrovskis
Minister for Economics, acting for the
Information on a Conformity Assessment Body
8. Description of the activities of the conformity assessment to be carried out (shall not be completed if it is a construction product)
9. Description of the activities of the conformity assessment to be carried out in accordance with the laws and regulations regarding conformity assessment of construction products
Minister for Economics, acting for the
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