12 Amendments of Aldo PATRICIELLO related to 2023/0132(COD)
Amendment 434 #
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 product. If a Member State chooses to provide the package leaflet in an electronic format, there is always the option to voluntarily offer a paper version of the package leaflet in addition to the electronic one. 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 434 #
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 product. If a Member State chooses to provide the package leaflet in an electronic format, there is always the option to voluntarily offer a paper version of the package leaflet in addition to the electronic one. 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 442 #
Proposal for a directive
Article 63 – paragraph 3 a (new)
Article 63 – paragraph 3 a (new)
3 a. By derogation from paragraph 3, if the medicinal product is not meant to be directly administered to the patient, the package leaflet can be provided electronically exclusively.
Amendment 442 #
Proposal for a directive
Article 63 – paragraph 3 a (new)
Article 63 – paragraph 3 a (new)
3 a. By derogation from paragraph 3, if the medicinal product is not meant to be directly administered to the patient, the package leaflet can be provided electronically exclusively.
Amendment 451 #
Proposal for a directive
Article 63 – paragraph 5
Article 63 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and eliminating the requirement to include a printed package leaflet within the packaging. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = fivone years following 18 months after the date of entering into force of this Directive].
Amendment 451 #
Proposal for a directive
Article 63 – paragraph 5
Article 63 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and eliminating the requirement to include a printed package leaflet within the packaging. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = fivone years following 18 months after the date of entering into force of this Directive].
Amendment 459 #
Proposal for a directive
Article 63 – paragraph 6
Article 63 – paragraph 6
6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of the text].
Amendment 459 #
Proposal for a directive
Article 63 – paragraph 6
Article 63 – paragraph 6
6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of the text].
Amendment 461 #
Proposal for a directive
Article 63 – paragraph 6 a (new)
Article 63 – paragraph 6 a (new)
6 a. Following consultation with Member States and pertinent stakeholders, the Agency will make a system available to accommodate the electronic product information in the database specified in Article 138(1)(n) and 138(2) of the Revised Regulation. By [30 months after publication], at the latest, the Agency will have the system operational and all Member States will be using it.
Amendment 461 #
Proposal for a directive
Article 63 – paragraph 6 a (new)
Article 63 – paragraph 6 a (new)
6 a. Following consultation with Member States and pertinent stakeholders, the Agency will make a system available to accommodate the electronic product information in the database specified in Article 138(1)(n) and 138(2) of the Revised Regulation. By [30 months after publication], at the latest, the Agency will have the system operational and all Member States will be using it.
Amendment 501 #
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 the ultimate decision of 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 licencse requires, and during the duration period of the compulsory licencefor the indication pertaining to the public health emergency, solely during the compulsory license's period, and, if applicable, exclusively within the Member State where the compulsory license is authorized. The competent authority relevant to the suspension of data and market protection shall notify the marketing authorization holder of the medicinal product prior to the effective date of such suspension.
Amendment 501 #
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 the ultimate decision of 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 licencse requires, and during the duration period of the compulsory licencefor the indication pertaining to the public health emergency, solely during the compulsory license's period, and, if applicable, exclusively within the Member State where the compulsory license is authorized. The competent authority relevant to the suspension of data and market protection shall notify the marketing authorization holder of the medicinal product prior to the effective date of such suspension.