[ParlTrack]

Proposal for a regulation
Recital 77

(77) The development of antimicrobial resistance is a growing concern and the pipeline of effective antimicrobials is obstructed due to a market failure; it is therefore necessary to consider new measures to incentivize companies' investments in research and development and to promote the development of priority antimicrobials that are effective against antimicrobial resistance and to support undertakings, often SMEs, which choose to invest in this area.

2023/11/21
Committee: ENVI

Annalisa TARDINO

Proposal for a regulation
Recital 79 a (new)

(79 a) In order to fight against antimicrobial resistance, push and pull incentives are to be considered essential at both Union and national level. In this regard, the creation of an AMR designation is needed to allow the identification of all products which could contribute to this aim and would provide the necessary focus to coherently target research and development and aceess incentives.

2023/11/21
Committee: ENVI

Annalisa TARDINO

Article 40a AMR designation 1. All AMR medicinal products developed to address a priority pathogen should be granted an AMR designation through an open and transparent Community procedure. 2. A medicinal product shall be designated as an AMR medicinal product if its sponsor can establish: 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 an equivalent list established at Union level. b) That there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Community or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition. 3. In order to obtain the designation of a medicinal product as an AMR medicinal product, the sponsor shall submit an application to the Agency before or at the moment of the application for marketing authorisation is made.The application shall be accompanied by the following particulars and documents: a) name or corporate name and permanent address of the sponsor; b) active ingredients of the medicinal product; c) proposed therapeutic indication; d) justification that the criteria laid down in Article x(y) are met, the indications expected and the relevant preclinical and clinical data. The Agency shall verify the validity of the application and ensure that an opinion is given within 90 days of the receipt of a valid application. 4. All products receiving AMR Designation shall be deemed to meet the criteria for Unmet Need specified in the Directive.

2023/11/21
Committee: ENVI

3 Amendments of Annalisa TARDINO related to 2023/0131(COD)

ParlTrack - 2011-2024