Contents
Article 8Working arrangements#
1.The Management Board of the Agency shall, on a reasoned proposal from the Executive Director and following a favourable opinion from the Commission, establish working arrangements to facilitate the application of this Regulation, including payment methods of the fees and charges levied by the Agency, the mechanism for payment of remuneration to competent authorities of the Member States under this Regulation, a total or partial reduction of applicable fees or charges in accordance with Article 6(4), and the establishment of a common format, based on a transparent methodology, to be used by competent authorities of the Member States or experts contracted for the work of the expert panels on medical devices when providing the financial information to the Agency in accordance with Article 10(4).
2.As part of the working arrangements referred to in paragraph 1, the Management Board of the Agency shall also establish the scope of a distinct inspection, for each type of inspection. This shall include, where relevant, the medicinal product concerned, the site concerned, the activity concerned and the inspection team concerned.
3.The Agency shall make the working arrangements publicly available on its website.
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