13 Amendments of Pietro FIOCCHI related to 2023/0131(COD)
Amendment 240 #
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. Following a request by the applicant when applying for afor a marketing authorisation, made before that marketing authorisation is granted, 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 introduced in other areas such as rare diseases.
Amendment 296 #
Proposal for a regulation
Article 63 – paragraph 2
Article 63 – paragraph 2
Amendment 299 #
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 301 #
Proposal for a regulation
Article 64 – paragraph 2 – subparagraph 1 – introductory part
Article 64 – paragraph 2 – subparagraph 1 – introductory part
The application for the designation of the orphan medicine sponsoral product shall be accompanied by the following particulars and documentation:
Amendment 304 #
Proposal for a regulation
Article 64 – paragraph 3
Article 64 – paragraph 3
3. The Agency shall verify the validity of the application and share its draft scientific conclusions with the applicant. The applicant shall be invited to provide their observations on the draft 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 305 #
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 2. Within the timelines for adoption of a decision foreseen in [subparagraph 1], the Agency shall transmit its scientific conclusions to the applicant. Within 30 days of receipt of the scientific conclusions, the sponsor may submit to the Agency a written request, citing detailed grounds, for a re-examination. Within 30 days following receipt of a request for re-examination, the Agency shall confirm or revise its previous scientific conclusions. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re-examining the above mentioned scientific conclusions. If, within the 30-day period referred to in [6th subparagraph], the applicant does not request re-examination, the scientific conclusions shall become definitive. The Agency shall adopt a decision within a period not exceeding 10 days following the date on which the scientific conclusions have become definitive
Amendment 310 #
Proposal for a regulation
Article 66 – paragraph 1
Article 66 – paragraph 1
Amendment 313 #
Proposal for a regulation
Article 66 – paragraph 2
Article 66 – paragraph 2
Amendment 317 #
Proposal for a regulation
Article 66 – paragraph 3
Article 66 – paragraph 3
Amendment 318 #
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). An orphan designation shall however remain valid in case the indication of the initial marketing authorisation addresses only a subset of the population affected by the designated orphan condition OR where the orphan medicinal product sponsor can provide evidence that studies supporting the use of the designated orphan medicinal product are planned or ongoing with respect to additional indications within the scope of the designated condition / orphan designation.
Amendment 344 #
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nintwelve years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 356 #
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) thirteen years for orphan medicinal products addressing a whigch unmet medicafulfil oneed as referred to in Article 70 of the following requirements ;
Amendment 360 #
Proposal for a regulation
Article 71 – paragraph 2 – point c
Article 71 – paragraph 2 – point c
(c) fiseven years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].