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Chapter II · JOINT WORK ON HEALTH TECHNOLOGY ASSESSMENT AT UNION LEVEL  ›  Section 1 · Joint clinical assessments › Article 15

Adoption of detailed procedural rules for joint clinical assessments

1.   The Commission shall adopt, by means of implementing acts, detailed procedural rules for:

(a)

cooperation, in particular by exchange of information, with the European Medicines Agency on the preparation and update of joint clinical assessments of medicinal products;

(b)

cooperation, in particular by exchange of information, with the notified bodies and expert panels on the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices;

(c)

interaction, including timing thereof, with and between the Coordination Group, its subgroups and the health technology developers, patients, clinical experts and other relevant experts during joint clinical assessments and updates.

2.   Implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 33(2).

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