43 Amendments of Massimiliano SALINI 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.
Amendment 528 #
Proposal for a regulation
Article 2 – paragraph 2 – point 7
Article 2 – paragraph 2 – point 7
(7) ‘significant benefit’ means a clinically relevant advantage or a major contribution to patient care of an orphan medicinal product if such an advantage or contribution benefits a substantial part of the target population;
Amendment 658 #
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
Amendment 665 #
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 886 #
Proposal for a regulation
Article 40 a (new)
Article 40 a (new)
Article40a AMR designation All AMR medicinal products designed to combat a priority pathogen should receive an AMR designation through a transparent and open Community procedure. An AMR medicinal product will be identified as such when its sponsor can demonstrate: a) That it is intended for the diagnosis, prevention or treatment of a pathogen included in the ‘WHO priority pathogens list for R&D of new antibiotics’, or a comparable list established at Union level. b) that there is no approved method within the community for diagnosing, preventing, or treating the specified condition that is deemed satisfactory. If such a method does exist, the medicinal product must provide substantial benefits to individuals suffering from the condition. 3. To secure the classification of a pharmaceutical product as an AMR medicinal product, the sponsor must submit an application to the Agency either prior to, or concurrently, with the submission for marketing authorization. The application should include the specified details and accompanying documents: a) name or corporate name and permanent address of the sponsor; b) active ingredients of the medicinal product; c) proposed therapeutic indication; d) verification of compliance with the criteria specified in Article x(y), confirmation of anticipated indications, and review of pertinent preclinical and clinical information constitute the rationale for the approval process. The Agency is responsible for validating the application's legitimacy and issuing an opinion within 90 days of receiving a valid application.
Amendment 890 #
Proposal for a regulation
Article 40 a (new)
Article 40 a (new)
Article40a Any product receiving AMR Designation shall be considered as meeting the criteria for Unmet Need outlined in the [revised Directive 2001/83/EC].
Amendment 1078 #
Proposal for a regulation
Article 66 – paragraph 1
Article 66 – paragraph 1
Amendment 1087 #
Proposal for a regulation
Article 66 – paragraph 2
Article 66 – paragraph 2
Amendment 1089 #
Proposal for a regulation
Article 66 – paragraph 3
Article 66 – paragraph 3
Amendment 1093 #
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.
Amendment 1123 #
Proposal for a regulation
Article 70
Article 70
Amendment 1160 #
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 1176 #
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 high unmetwhich satisfy any of the following criteria: i. there is no medicinal product authorised in the Union for such condition or where ii. even though the Union has authorized medicinal need as referred to in Article 70; products for such condition, the applicant demonstrates that the orphan medicinal product, in addition to having a significant benefit, will result in exceptional therapeutic advancement or iii. the condition affects not more than 0,5 in 10,000 persons in the Union when the application for an orphan designation is submitted.
Amendment 1199 #
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].
Amendment 1229 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1
Article 72 – paragraph 1 – subparagraph 1
Amendment 1239 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 2
Article 72 – paragraph 1 – subparagraph 2
Amendment 1246 #
The period of market exclusivity shall be prolonged by an additional 124 months for orphan medicinal products referred to in Article 71(2), points (a) and (b), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition. If the recently approved therapeutic indication satisfies one of the criteria mentioned in Article 71(2) point (b) and a period of market exclusivity was not granted for the first orphan marketing authorization as mentioned in Article 71(2) point (b), the period of market exclusivity shall be extended by a total of 36 months.
Amendment 1255 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2
Article 72 – paragraph 2 – subparagraph 2
Amendment 1261 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2 a (new)
Article 72 – paragraph 2 – subparagraph 2 a (new)
After the orphan medical product in question first receives an authorization as stated in Article 69, the holder of an orphan marketing authorization shall be entitled to a maximum of [15] years of orphan marketing exclusivity.
Amendment 1262 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2 b (new)
Article 72 – paragraph 2 – subparagraph 2 b (new)
If requested by the applicant as an option instead of the stipulated reward in Article 86 of the revised Directive, the duration of market exclusivity for orphan medicinal products, as specified in Article 71(2), points (a) and (b), will be extended by an extra 24 months. This extension applies when an application for orphan marketing authorization is submitted for a designated orphan medicinal product under the Revised Regulation, and the application incorporates the findings of all studies conducted in adherence to an agreed-upon paediatric investigation plan. The first subparagraph shall also be applicable where fulfilment of the stipulated paediatric investigation plan does not result in the approval of a pediatric indication. However, the findings from the conducted studies should be incorporated into the summary of product characteristics and, if deemed suitable, into the package leaflet of the respective medicinal product. The extension of the market exclusivity period by 24 months will be acknowledged in the marketing authorization.
Amendment 1271 #
Proposal for a regulation
Article 72 – paragraph 3 a (new)
Article 72 – paragraph 3 a (new)
3 a. The restriction mentioned in paragraph 3 shall not apply when the orphan marketing exclusivity period is prolonged as outlined in paragraph 4 concerning that extension.
Amendment 1272 #
Proposal for a regulation
Article 72 – paragraph 3 b (new)
Article 72 – paragraph 3 b (new)
3 b. The extended market exclusivity mentioned in paragraph 2 does not apply to orphan medicinal products, and they will not receive the extra period of data protection outlined in Article 81(2), point (d) of the revised Directive 2001/83/EC.
Amendment 1356 #
Proposal for a regulation
Article 91 – paragraph 1
Article 91 – paragraph 1
1. Any clinical study which involves the use in the paediatric population of a medicinal product covered by a marketing authorisation and is sponsored by the marketing authorisation holder, whether or not it is conducted in compliance with an agreed paediatric investigation plan, shall be submitted to the Agency or to the Member States which have previously authorised the medicinal product concerned within six12 months of completion of the studies concerned.
Amendment 1362 #
Proposal for a regulation
Article 94 – paragraph 2 – subparagraph 2
Article 94 – paragraph 2 – subparagraph 2
Irrespective of the outcome of a clinical trial within 612 months from the end of the trial the clinical trial sponsor, the addressee of the Agency's decision on a paediatric investigation plan or the marketing authorisation holder as appropriate, shall submit to the EU database a summary of the results of the trial shall be uploaded in the database.
Amendment 1363 #
Proposal for a regulation
Article 94 – paragraph 2 – subparagraph 3
Article 94 – paragraph 2 – subparagraph 3
Amendment 1415 #
Proposal for a regulation
Article 113 – paragraph 3
Article 113 – paragraph 3
3. The Agency shall monitor the field of emerging medicinal products and may shall request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and mayshall engage with them in preliminary discussions, where appropriate referring to the consultation mechanism provided in Article 162.
Amendment 1422 #
Proposal for a regulation
Article 113 – paragraph 4 – subparagraph 1
Article 113 – paragraph 4 – subparagraph 1
Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commissionproducts, which might be regulated as medicinal products (including advanced therapy medicines), medical equipment, in-vitro diagnostics, substances of human origin, it shall provide a recommendation to the Commission, where appropriate after invoking the consultation mechanism of Article 162. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.
Amendment 1446 #
Proposal for a regulation
Article 113 – paragraph 9
Article 113 – paragraph 9
9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by the adoption of supplementary conditionsadapting the relevant requirements and conditions set out in paragraphs 6 and 7, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).
Amendment 1453 #
Proposal for a regulation
Article 114 – paragraph 3
Article 114 – paragraph 3
3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and other relevant Union legislation . Thoese derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation.
Amendment 1460 #
Proposal for a regulation
Article 115 – paragraph 1 – subparagraph 1
Article 115 – paragraph 1 – subparagraph 1
The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspend or restrict their use and inform the Commission in accordance with Article 113(2).
Amendment 1479 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than sixtwo months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1497 #
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the marketUnion list of critical medicinal products mentioned in Article 131 . To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.