uniform application Archives - Pavel, Margarit and Associates

According to Law No. 50/2015, with the approval of Government Ordinance No. 20/2010, there have been brought a number of changes thereto. So, it is regulated the situation in which the harmonization legislation of the European Union requires that the conformity assessment to be made by notification assessment of conformity bodies, then, competent authorities will acquire the position of notification bodies and are responsible for setting and meeting the necessary procedures for assessment, designation and notification of conformity assessment bodies, as well as the monitoring of notified bodies. If the European Union harmonization legislation does not provide otherwise, the competent authorities may decide that the assessment and monitoring referred to in paragraph (1) to be made by: a) a national accreditation body, in accordance with the provisions of Regulation (EC) no. 765/2008; or b) Notwithstanding the provisions from letter a), by: (i) the Authority itself; or (ii) a body which is not a governmental entity, Romanian legal entity, which meets the following requirements: - it is set so that there are no conflicts of interest with conformity assessment bodies; - is organized and operates so that to guarantee the objectivity and impartiality of its activities; - the decision of the outcome evaluation of the conformity assessment body is taken by a competent person / competent persons, other / other than that / those that has / have carried out the assessment; - does not perform activities performed by the conformity assessment bodies nor consulting services on commercial or competitive conditions; - guarantees the confidentiality of the information obtained; - has sufficient competent personnel for the proper performance of his duties; - has signed agreements / deals that provide coverage of the responsibilities arising from its activities. In applying these provisions, the competent authorities shall establish, as appropriate, by order of the head of the competent authority: a) the entity according to paragraph (2), responsible for assessing the conformity assessment bodies and the monitoring of notified bodies; b) the procedure for designation of conformity assessment bodies which are notified and notifying them to the European Commission and other Member States of the European Union. The Ministry of Economy, Trade and Tourism coordinates the quality infrastructure domain, as well as the market surveillance activities, according to the applicable requirements set out in Regulation (EC) no. 765/2008. To this end, in the Ministry of Economy, Trade and Tourism operates a proper structure.

Tag uniform application

There were established the measures for the uniform application of EU legislation harmonizing the conditions for the marketing of products