20 Amendments of Nicola DANTI related to 2023/0132(COD)
Amendment 380 #
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – 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, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients' access to existing treatments;
Amendment 380 #
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – 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, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients' access to existing treatments;
Amendment 402 #
Proposal for a directive
Article 57 – paragraph 1
Article 57 – paragraph 1
1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority or publicly funded body of the European Union, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.
Amendment 402 #
Proposal for a directive
Article 57 – paragraph 1
Article 57 – paragraph 1
1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority or publicly funded body of the European Union, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.
Amendment 427 #
Proposal for a directive
Article 63 – paragraph 3
Article 63 – paragraph 3
3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal productAfter carefully considering all relevant factors, including but not limited to the level of digitalisation of the country and the status of digital literacy of its citizens, Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. The electronic format should allow the reactive integration of new data on the drug including pharmacovigilance data. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If a Member State decides that the package leaflet shall be made available electronically, a paper package leaflet in addition to the electronic format may always be made available on a voluntary basis. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.
Amendment 427 #
Proposal for a directive
Article 63 – paragraph 3
Article 63 – paragraph 3
3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal productAfter carefully considering all relevant factors, including but not limited to the level of digitalisation of the country and the status of digital literacy of its citizens, Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. The electronic format should allow the reactive integration of new data on the drug including pharmacovigilance data. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If a Member State decides that the package leaflet shall be made available electronically, a paper package leaflet in addition to the electronic format may always be made available on a voluntary basis. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.
Amendment 437 #
Proposal for a directive
Article 63 – paragraph 3 – subparagraph 1 (new)
Article 63 – paragraph 3 – subparagraph 1 (new)
By derogation from paragraph 3, when the medicinal products is not delivered directly to the patients, such as in hospital environment, the package leaflet may be available only in electronic format.
Amendment 437 #
Proposal for a directive
Article 63 – paragraph 3 – subparagraph 1 (new)
Article 63 – paragraph 3 – subparagraph 1 (new)
By derogation from paragraph 3, when the medicinal products is not delivered directly to the patients, such as in hospital environment, the package leaflet may be available only in electronic format.
Amendment 502 #
Proposal for a directive
Article 80 – paragraph 4
Article 80 – paragraph 4
4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory licence requires, and duringexclusively for the duration period of the compulsory licence and, where applicable, only in the Member States where the compulsory licence is granted.
Amendment 502 #
Proposal for a directive
Article 80 – paragraph 4
Article 80 – paragraph 4
4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory licence requires, and duringexclusively for the duration period of the compulsory licence and, where applicable, only in the Member States where the compulsory licence is granted.
Amendment 508 #
Proposal for a directive
Article 81 – paragraph 1
Article 81 – paragraph 1
1. The regulatory data protection period shall be sixnine years from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union.
Amendment 508 #
Proposal for a directive
Article 81 – paragraph 1
Article 81 – paragraph 1
1. The regulatory data protection period shall be sixnine years from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union.
Amendment 525 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point b
Article 81 – paragraph 2 – subparagraph 1 – point b
(b) six12 months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;
Amendment 525 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point b
Article 81 – paragraph 2 – subparagraph 1 – point b
(b) six12 months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;
Amendment 528 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point c
Article 81 – paragraph 2 – subparagraph 1 – point c
(c) six12 months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency in consultation with health technology assessment authorities, set out in a delegated act in accord with article 215;
Amendment 528 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point c
Article 81 – paragraph 2 – subparagraph 1 – point c
(c) six12 months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency in consultation with health technology assessment authorities, set out in a delegated act in accord with article 215;
Amendment 537 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d c (new)
Article 81 – paragraph 2 – subparagraph 1 – point d c (new)
(d c) 12 months, where the marketing authorisation applicant has committed to support the establishment of public- private partnerships, University Hospital Institutes, centres of excellence and bioclusters to accelerate research and development of a new medicinal product.
Amendment 537 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d c (new)
Article 81 – paragraph 2 – subparagraph 1 – point d c (new)
(d c) 12 months, where the marketing authorisation applicant has committed to support the establishment of public- private partnerships, University Hospital Institutes, centres of excellence and bioclusters to accelerate research and development of a new medicinal product.
Amendment 538 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d d (new)
Article 81 – paragraph 2 – subparagraph 1 – point d d (new)
(d d) 12 months, for medicinal products containing critical active pharmaceutical ingredients produced within the EU.
Amendment 538 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d d (new)
Article 81 – paragraph 2 – subparagraph 1 – point d d (new)
(d d) 12 months, for medicinal products containing critical active pharmaceutical ingredients produced within the EU.