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Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance)

article  13

CELEX:  32021R2282

1. When carrying out a national HTA on a health technology for which joint clinical assessment reports have been published or in respect of which a joint clinical assessment has been initiated, Member States shall:
(a) give due consideration to the published joint clinical assessment reports and all other information available on the IT platform referred to in Article 30, including the statement of discontinuation pursuant to Article 10(6), concerning that joint clinical assessment in their HTAs at Member State level; this shall not affect Member States’ competence to draw their conclusions on the overall clinical added value of a health technology in the context of their specific healthcare system and to consider the parts of those reports relevant in that context;
(b) annex the dossier submitted by the health technology developer in accordance with Article 10(2) to the documentation of the HTA at Member State level;
(c) annex the published joint clinical assessment report to the HTA report at Member State level;
(d) not request at the national level information, data, analyses or other evidence that has been submitted by the health technology developer at Union level in accordance with Article 10(1) or (5);
(e) immediately share through the IT platform referred to in Article 30 any information, data, analyses and other evidence with the Coordination Group that they receive from the health technology developer at Member State level and which form part of the submission request made pursuant to Article 10(1).
Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance)

article  13

CELEX:  32021R2282

2. Member States shall provide the Coordination Group through the IT platform referred to in Article 30 with information on the national HTA in respect of a health technology which has been subject to a joint clinical assessment within 30 days from the date of its completion. In particular, Member States shall provide information on how joint clinical assessment reports have been considered when carrying out a national HTA. The Commission shall, based on information from Member States, summarise the uptake of the joint clinical assessment reports in HTAs at Member State level and publish a report on that overview on the IT platform referred to in Article 30 at the end of each year to facilitate the exchange of information between Member States.