19 Amendments of Andreas GLÜCK related to 2023/0132(COD)
Amendment 387 #
Proposal for a directive
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.
Amendment 430 #
Proposal for a directive
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2 a. Member States may authorise the cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of shortages of critical medicines or to ensure the treatment of patients affected by rare diseases, in the absence of other solutions.
Amendment 436 #
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 formatelectronically, or electronically, or both and in paper format. 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 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 i. It should be ensured that the information in digital format is easily accessible to all patients.
Amendment 436 #
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 formatelectronically, or electronically, or both and in paper format. 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 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 i. It should be ensured that the information in digital format is easily accessible to all patients.
Amendment 509 #
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 509 #
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 514 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a
Article 81 – paragraph 2 – subparagraph 1 – point a
Amendment 514 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a
Article 81 – paragraph 2 – subparagraph 1 – point a
Amendment 545 #
Proposal for a directive
Article 82
Article 82
Amendment 545 #
Proposal for a directive
Article 82
Article 82
Amendment 580 #
Proposal for a directive
Article 83 – paragraph 1 – point a
Article 83 – paragraph 1 – point a
(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, a new form of administration leads to treatment of patients who previously had no access to the product or the disease is associated with a remaining high morbidity or mortality;
Amendment 580 #
Proposal for a directive
Article 83 – paragraph 1 – point a
Article 83 – paragraph 1 – point a
(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, a new form of administration leads to treatment of patients who previously had no access to the product or the disease is associated with a remaining high morbidity or mortality;
Amendment 668 #
Proposal for a directive
Article 23 – paragraph 4 a (new)
Article 23 – paragraph 4 a (new)
4 a. The Agency shall ensure that the ERA is followed by clear recommandations to the marketing authorisation holders on how to respect the guidelines and to fulfill the requirements in the future.
Amendment 733 #
Proposal for a directive
Article 195 – paragraph 2
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder. The responsible authority must clearly consider whether this suspension is proportionate to the loss for the affected patients and should first consider further steps to reduce the risk.
Amendment 763 #
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 789 #
Proposal for a directive
Article 51 – paragraph 2
Article 51 – paragraph 2
2. Member States may setdecide to make an antimicrobial other than those referred to in paragraph 1 point (e) subject to prescription, and additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned by authorising the use of pre-cut blister units or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription.
Amendment 1544 #
Proposal for a directive
Article 195 – paragraph 2
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder. The responsible authority must clearly consider whether this suspension is proportionate to the loss for the affected patients and should first consider further steps to reduce the risk.
Amendment 1545 #
Proposal for a directive
Article 195 – paragraph 2
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients' access to existing treatments.
Amendment 1565 #
Proposal for a directive
Article 200 – paragraph 4 – subparagraph 1
Article 200 – paragraph 4 – subparagraph 1
The competent authority of the Member State may process personal health data from sources other than clinical studies, including real world data, to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder.