4 Amendments of Cindy FRANSSEN related to 2023/0132(COD)
Amendment 417 #
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). The scale of non-routine basis use cannot exceed the treatment capacity of a hospital. Member States shall ensure that only hospitals are granted hospital exemptions.
Amendment 423 #
Proposal for a directive
Article 2 – paragraph 1 a (new)
Article 2 – paragraph 1 a (new)
1 a. Whenever a hospital exemption exceeds preparation on a non-routine basis, holders of this exemption are granted a transition period of 5 years to obtain a centralised marketing authorisation for the advanced therapy medicinal product under the hospital exemption. For the duration of this transition period, the holder may exceed preparation on non-routine basis in order to guarantee patient access. Member States shall ensure that the use remains focused on unmet medical needs in situations when similar treatment is not available and/or affordable.
Amendment 429 #
Proposal for a directive
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2 a. Without prejudice to the requirements of Articles 2(3), 2(4), 2,(5) and 2(6), Member States may allow for cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of unmet needs, under the condition that preparation on a non-routine basis is maintained and following approval of the importing Member States' competent authority. Competent authorities should share information on hospital exemption approvals on their territory and upon request also share the evidence used for such approvals after approval of the exemption holder.
Amendment 454 #
Proposal for a directive
Article 2 – paragraph 6
Article 2 – paragraph 6
6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data. The Agency shall ensure that an overview of approved advanced therapy medicinal products prepared under hospital exemption is made public.