BETA

Activities of Erik BÁNKI related to 2012/0035(COD)

Plenary speeches (1)

Transparency of measures regulating the prices of medicinal products for human use (debate)
2016/11/22
Dossiers: 2012/0035(COD)

Amendments (12)

Amendment 86 #
Proposal for a directive
Article 2 – point 3 a (new)
(3a) "biosimilar medicinal product" means a similar biological medicinal product approved in accordance with Article 10(4) of Directive 2001/83/EC;
2012/10/22
Committee: ENVI
Amendment 98 #
Proposal for a directive
Article 3 – paragraph 3
(3) Member States shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorisation. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 125 days, provided that the price of the reference medicinal product has been approved by the competent authorities.
2012/10/22
Committee: ENVI
Amendment 103 #
Proposal for a directive
Article 3 – paragraph 3
3. Member States shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorisation. However, with respect to medicinal products for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 125 days, provided that the price of the reference medicinal product has been approved by the competent authorities. With respect to biosimilar medicinal products, that time limit shall be 60 days, provided that the price of the reference medicinal product has been approved by the competent authorities.
2012/10/22
Committee: ENVI
Amendment 111 #
Proposal for a directive
Article 3 – paragraph 5
5. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be in all events 125 days, provided that the price of the reference medicinal product has been approved by the competent authorities. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
2012/10/22
Committee: ENVI
Amendment 118 #
Proposal for a directive
Article 3 – paragraph 5
5. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be in all events 125 days, provided that the price of the reference medicinal product has been approved by the competent authorities. With respect to biosimilar medicinal products, that time limit shall be in all events 60 days, provided that the price of the reference medicinal product has been approved by the competent authorities. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
2012/10/22
Committee: ENVI
Amendment 184 #
Proposal for a directive
Article 7 – paragraph 4
(4) Member States shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system, submitted by the marketing authorisation holder in accordance with the requirements laid down in the Member State concerned, is adopted and communicated to the applicant within 60 days of its receipt. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 125 days, provided that the reference medicinal product has already been included in the public health insurance system.
2012/10/25
Committee: ENVI
Amendment 189 #
Proposal for a directive
Article 7 – paragraph 4
4. Member States shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system, submitted by the marketing authorisation holder in accordance with the requirements laid down in the Member State concerned, is adopted and communicated to the applicant within 60 days of its receipt. However, with respect to medicinal products for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 125 days, provided that the reference medicinal product has already been included in the public health insurance system. With respect to biosimilar medicinal products, that time limit shall be 60 days, provided that the reference medicinal product has already been included in the public health insurance system.
2012/10/25
Committee: ENVI
Amendment 194 #
Proposal for a directive
Article 7 – paragraph 5
(5) If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 125 days, provided that the reference medicinal product has already been included in the public health insurance system. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
2012/10/25
Committee: ENVI
Amendment 200 #
Proposal for a directive
Article 7 – paragraph 5
5. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information. However, with respect to medicinal products for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 1525 days, provided that the reference medicinal product has already been included in the public health insurance system. With respect to biosimilars medicinal products, that time limit shall be 60 days, provided that the reference medicinal product has already been included in the public health insurance system. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
2012/10/25
Committee: ENVI
Amendment 204 #
Proposal for a directive
Article 7 – paragraph 6
(6) Irrespective of the organisation of their internal procedures, Member States shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this Article and the price approval procedure set out in Article 3 does not exceed 120 days. However, with respect to the medicinal products for which Member States use health technology assessment as part of their decision-making process, the time limit shall not exceed 180 days. With respect to generic medicinal products, that time limit shall not exceed 350 days, provided that the reference medicinal product has already been included in the public health insurance system. Those time-limits may be extended in accordance with paragraph 5 of this Article or Article 3(5). .
2012/10/25
Committee: ENVI
Amendment 209 #
Proposal for a directive
Article 7 – paragraph 6
6. Irrespective of the organisation of their internal procedures, Member States shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this Article and the price approval procedure set out in Article 3 does not exceed 120 days. However, with respect to the medicinal products for which Member States use health technology assessment as part of their decision-making process, the time limit shall not exceed 180 days. With respect to generic medicinal products, that time limit shall not exceed 350 days, provided that the reference medicinal product has already been included in the public health insurance system. With respect to biosimilar medicinal products, that time limit shall not exceed 120 days, provided that the reference medicinal product has already been included in the public health insurance system. Those time-limits may be extended in accordance with paragraph 5 of this Article or Article 3(5).
2012/10/25
Committee: ENVI
Amendment 261 #
Proposal for a directive
Article 16
Article 16 Notification of draft national measures (1) Where Member States intend to adopt or amend any measure falling within the scope of this Directive, they shall immediately communicate to the Commission the draft measure envisaged, together with the reasoning on which the measure is based. (2) Where appropriate, Member States shall simultaneously communicate the texts of the basic legislative or regulatory provisions principally and directly concerned, if knowledge of such texts is necessary to assess the implications of the measure proposed. (3) Member States shall communicate the draft measure referred to in paragraph 1 again if they make changes to the draft that have the effect of significantly altering its scope or substance, or shortening the timetable originally envisaged for implementation. (4) The Commission may send its observations to the Member State which has communicated the draft measure within three months. The observations of the Commission shall be taken into account as far as possible by the Member State concerned, in particular if the observations indicate that the draft measure may be incompatible with Union law. (5) When the Member State concerned definitively adopts the draft measure, it shall communicate the final text to the Commission without delay. If observations have been made by the Commission in accordance with paragraph 4, this communication shall be accompanied by a report on the actions taken in response to the observations of the Commission.deleted
2012/10/25
Committee: ENVI