12 Amendments of Aldo PATRICIELLO related to 2023/0131(COD)
Amendment 183 #
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
Amendment 187 #
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant;re is no agreement on the content or timing of post-authorisation studies to further explain environmental risk assessment, as stated by article 20(c).
Amendment 239 #
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. Following a request by the applicant when applying for a marketing authorisation, issued prior to the granting of the marketing authorization, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency or alternatively incentives already implemented in other domains such as rare diseases.
Amendment 295 #
Proposal for a regulation
Article 63 – paragraph 2
Article 63 – paragraph 2
Amendment 300 #
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
1. The orphan medicineal product sponsor shall submit an application for the designation of the orphan medicinal product to the Agency at any stage of the development of the medicinal product before the application for marketing authorisation referred to in Articles 5 and 6 is submitted.
Amendment 302 #
Proposal for a regulation
Article 64 – paragraph 2 – subparagraph 1 – introductory part
Article 64 – paragraph 2 – subparagraph 1 – introductory part
The application ofor the orphan medicine sponsoral product designation shall be accompanied by the following particulars and documentation:
Amendment 303 #
Proposal for a regulation
Article 64 – paragraph 3
Article 64 – paragraph 3
3. The Agency shall confirm the application's validity and share its preliminary scientific findings with the applicant. The applicant shall be requested to provide their comments on these preliminary conclusions. The Agency shall, in consultation with the Member States, the Commission and interested parties, draw up detailed guidelines on the required procedure, format and content of applications for designation and for the transfer of the orphan designation pursuant to Article 65.
Amendment 306 #
Proposal for a regulation
Article 64 – paragraph 4 – subparagraph 1
Article 64 – paragraph 4 – subparagraph 1
The Agency shall adopt a decision granting or refusing the orphan designation based on the criteria referred to in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2) within 90 days of the receipt of a valid application. The application is considered valid if it includes all the particulars and documentation referred to in paragraph 2within 90 days of the receipt of a valid application. The Agency shall deliver its scientific findings to the applicant within the specified timeframes outlined for adoption of a decision in [subparagraph 1]. After receiving the scientific conclusions, the sponsor has a 30-day window in which they may submit a written request to the Agency, providing specific reasons, for a re-evaluation. Following a request for re-evaluation, the Agency shall either confirm or modify its initial scientific findings within 30 days. If necessary, the Agency may consult the Committee for Medicinal Products for Human Use or relevant working parties during the re-evaluation process. If, within the 30-day period referred to in [6th subparagraph], the applicant decides not to request a re-evaluation, the scientific conclusions shall become definitive. Once the scientific conclusions become definitive, the Agency shall reach a decision within 10 days.
Amendment 309 #
Proposal for a regulation
Article 66 – paragraph 1
Article 66 – paragraph 1
Amendment 312 #
Proposal for a regulation
Article 66 – paragraph 2
Article 66 – paragraph 2
Amendment 315 #
Proposal for a regulation
Article 66 – paragraph 3
Article 66 – paragraph 3
Amendment 319 #
Proposal for a regulation
Article 66 – paragraph 4
Article 66 – paragraph 4
4. An orphan designation ceases to be valid once an orphan medicine sponsor has obtained a marketing authorisation for the relevant medicinal product in accordance with Article 13(2). However, when the original marketing authorization only addresses part of the population affected by the designated orphan condition, the orphan designation shall remain valid.