13 Amendments of Susana SOLÍS PÉREZ related to 2022/0099(COD)
Amendment 165 #
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18 a) Metered Dose Inhalers (MDIs) are life-saving medicines for patients suffering from asthma and chronic obstructive pulmonary disease. To avoid any shortages and ensure a smooth transition to safe, accessible and affordable alternatives, the European Commission, the European Medicine Agency and the Health Emergency Preparedness and Response Authority together with patient associations and healthcare professionals' organisations shall work closely together.
Amendment 415 #
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. The use of desflurane as inhalation anaesthetic is prohibited as from 1 January 20269, except when such use is strictly required and no other anaesthetic can be used on medical grounds. The user shall provide evidence, upon request, on the medical justification to the competent authority of the Member State and the Commission.
Amendment 423 #
Proposal for a regulation
Article 16 – paragraph 2 – point c
Article 16 – paragraph 2 – point c
(c) supplied directly by a producer or an importer to undertakings, for export out of the Union, not contained in products or equipmentin pre-charged equipment referred to in Article 19(1), where those hydrofluorocarbons are not subsequently made available to any other party within the Union, prior to export;
Amendment 430 #
Proposal for a regulation
Article 16 – paragraph 2 – point e
Article 16 – paragraph 2 – point e
(e) supplied directly by a producer or an importer to an undertaking using it for the etching of semiconductor material or the cleaning of chemicals vapour deposition chambers within the semiconductor manufacturing sectorproducing metered dose inhalers for the delivery of pharmaceutical ingredients using a propellant with a GWP of less than 150.
Amendment 432 #
Proposal for a regulation
Article 16 – paragraph 2 – point e a (new)
Article 16 – paragraph 2 – point e a (new)
(e a) supplied directly by a producer or an importer for medical use if the usage is of medical necessity and if no other suitable alternative is available.
Amendment 442 #
Proposal for a regulation
Article 16 – paragraph 4 – subparagraph 1 – introductory part
Article 16 – paragraph 4 – subparagraph 1 – introductory part
Following a substantiated request by a competent authority of a Member State or an Agency of the EU, or the Consultation Forum, and taking into account the objectives of this Regulation, the Commission may, exceptionally by means of implementing acts, authorise an exemption for up to four years to exclude from the quota requirement laid down in paragraph 1 hydrofluorocarbons for use in specific applications, or specific categories of products or equipment, where it is demonstrated in the request that:
Amendment 447 #
Proposal for a regulation
Article 16 – paragraph 4 – subparagraph 1 – point a
Article 16 – paragraph 4 – subparagraph 1 – point a
(a) for those particular applications, products or equipment, alternatives are not available, or cannot be used for technical or safety reasons or risks to public health; and
Amendment 453 #
Proposal for a regulation
Article 16 – paragraph 4 – subparagraph 2
Article 16 – paragraph 4 – subparagraph 2
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(2). (a). Where a request concerns protection of public health, and imperative grounds of urgency so require, the Commission shall adopt delegated acts in accordance with the procedure provided for in Article 32 (1a) in order to authorise an exemption referred to in paragraph 4 of this Article.
Amendment 470 #
Proposal for a regulation
Article 17 – paragraph 6
Article 17 – paragraph 6
6. The Commission is empowered to adopt delegated acts in accordance with Article 32 to amend paragraph 5 as regards the amounts due for the allocation of quota and the mechanism to allocate remaining quotas, where necessary to prevent major disruptions of the market of hydrofluorocarbons, or any disruption to the supply of pharmaceutical products, or where the mechanism is not fulfilling its purpose and is having undesirable or unintended effects, including on public health.
Amendment 542 #
Proposal for a regulation
Article 33 – paragraph 1
Article 33 – paragraph 1
The Commission shall establish a Consultation Forum for providing advice and expertisedirection in relation to the implementation of this Regulation. A dedicated sub-group of the Consultation Forumshall be established to ensure close cooperation with the European Medicines Agency as well as Member State authorities to evaluate unintended effects on public health. It shall deliver a yearly report as of 2025 which the European Commission shall act on in accordance with Article 32. The rules of procedure of the Consultation Forum shall be established by the Commission and shall be published.
Amendment 566 #
Proposal for a regulation
Annex VII – point 4 – point ii
Annex VII – point 4 – point ii
ii) in addition, for importers and producers that have reported the placing on the market of hydrofluorocarbons for the usage referred to in Article 26(5), second subparagraph, a reference value based on the annual average of the quantities of those hydrofluorocarbons for such usage lawfully placed on the market from 1 January 2020 as reported under Article 19 of Regulation (EU) No 517/2014 and of Article 26 of this Regulation for the years available, on the basis of available data. Quota allocated for usage referred to in Article 26(5), second sub-paragraph, cannot be transferred to other applications until (a) the quota is exhausted or (b) the needs of producers of metered dose inhalers have been met. In this case, remaining quota can be allocated to other applications until the end of Q1 of the following year
Amendment 571 #
Proposal for a regulation
Annex VIII – point 1 – paragraph 2 – indent 2
Annex VIII – point 1 – paragraph 2 – indent 2
– in addition, where relevant, a quota corresponding to the reference value referred to in Annex VII, point 4(ii). From 1 January 2030 a quota corresponding to the reference value referred to in Annex VII, point 4(ii), multiplied by the maximum quantity for the year for which the quota is allocated divided by the maximum quantity for the year 2024.
Amendment 576 #
Proposal for a regulation
Annex VIII – point 1 – paragraph 3
Annex VIII – point 1 – paragraph 3
In case where after allocating the full amount of quotas as referred to in the second subparagraph, the maximum quantity is exceeded, all quotas allocated under Annex VII, point 4(i) will be reduced proportionally.