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5 Amendments of Jessica POLFJÄRD related to 2023/0132(COD)

Amendment 270 #
Jessica POLFJÄRD
Proposal for a directive
Recital 61
(61) When a compulsory licence has been granted by a relevant authority in the Union to tackle a public health emergency, regulatory data protection may, if still in force, prevent the effective use of the compulsory licence as they impede the authorisation of generic medicinal products, and thus access to the medicinal products needed to address the crisis. For this reason, data and market protection should be suspended when a compulsory licence has been issued to tackle a public health emergency. Such a suspension of the regulatory data protection should be allowed only in relation to the compulsory licence granted and its beneficiary. The suspension shall comply with the objective, the territorial scope, the duration and the subject matter of the granted compulsory licence.deleted
2023/11/21
Committee: ENVI
Amendment 274 #
Jessica POLFJÄRD
Proposal for a directive
Recital 62
(62) The suspension of the regulatory data protection should be granted only for the duration of the compulsory licence. A ‘suspension‘ of data and market protection in cases of public health emergency shall mean that data and market protection shall produce no effect in relation to the particular licensee of the compulsory licence while that compulsory licence is in effect. When the compulsory licence ends, the data and market protection shall resume their effect. The suspension should not result in an extension of the original duration.deleted
2023/11/21
Committee: ENVI
Amendment 328 #
Jessica POLFJÄRD
Proposal for a directive
Recital 70
(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation holder should be refusedsubject to proportionate measures to establish compliance. The ERA should be updated when new data or knowledge about relevant risks become available.
2023/11/21
Committee: ENVI
Amendment 1229 #
Jessica POLFJÄRD
Proposal for a directive
Article 84 – paragraph 1 – point b
(b) the medicinal product is authorised in accordance with Articles 9 to 12 and has not previously benefitted from data protection, or 2516 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.
2023/11/21
Committee: ENVI
Amendment 1236 #
Jessica POLFJÄRD
Proposal for a directive
Article 84 – paragraph 2
2. The data protection period referred to in paragraph 1 may only be granted once for any given medicinal product.deleted
2023/11/21
Committee: ENVI
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