Relevant information for the development of the assessment scope
Article 2
1. Health technology developers shall, at the same time as they submit to the European Medicines Agency an application for marketing authorisation for medicinal products referred to in Article 7(1), point (a), of Regulation (EU) 2021/2282, provide the HTA secretariat with relevant information for developing the assessment scope of a joint clinical assessment of those medicinal products. That information shall consist of: (a) the summary of the product characteristics proposed by the applicant; (b) the clinical overview section of the submission file to the European Medicines Agency. 2. Health technology developers shall, at the same time as they submit to the European Medicines Agency an application for a variation to the terms of an existing marketing authorisation for medicinal products referred to in Article 7(1), point (b), of Regulation (EU) 2021/2282, provide the HTA secretariat with relevant information on the development of the assessment scope of a joint clinical assessment of those medicinal products. That information shall consist of the new therapeutic indication proposed by the applicant and the clinical overview section of the submission file to the European Medicines Agency. 3. If the JCA Subgroup considers it necessary, the HTA secretariat shall invite the health technology developer to provide further information relevant for the development of the assessment scope in a meeting with the JCA Subgroup or in writing.