11 Amendments of Kārlis ŠADURSKIS related to 2012/0035(COD)
Amendment 101 #
Proposal for a directive
Article 3 – paragraph 3
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 690 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 1590 days, provided that the price of the reference medicinal product has been approved by the competent authorities.
Amendment 115 #
Proposal for a directive
Article 3 – paragraph 5
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 690 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 1590 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.
Amendment 132 #
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 1
Article 4 – paragraph 3 – subparagraph 1
Member States shall ensure that a decision on an application submitted in accordance with the requirements laid down in the Member State concerned, by a marketing authorisation holder to increase the price of a medicinal product is adopted and communicated to the applicant within 690 days of its receipt.
Amendment 138 #
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 2
Article 4 – paragraph 3 – subparagraph 2
In case of an exceptional number of applications, the time limit set out in this paragraph may be extended once only for a further 690 days. The applicant shall be notified of such an extension before the expiry of the time limit set out in this paragraph.
Amendment 148 #
Proposal for a directive
Article 4 – paragraph 4 – subparagraph 2
Article 4 – paragraph 4 – subparagraph 2
The applicant shall furnish the competent authorities with adequate information, including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested. 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 690 days of receipt of this additional information. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
Amendment 161 #
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
Member States shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 690 days of the receipt of the application. 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 690 days of receipt of this additional information. If the derogation is granted, the competent authorities shall forthwith publish an announcement of the price increase allowed.
Amendment 168 #
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 2
Article 5 – paragraph 3 – subparagraph 2
If there is an exceptional number of applications, the relevant time limit set out in paragraph 3 may be extended once only for a further 690 days. The applicant shall be notified of such extension before the expiry of the time limit set out in paragraph 3
Amendment 186 #
Proposal for a directive
Article 7 – paragraph 4
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 690 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 1590 days, provided that the reference medicinal product has already been included in the public health insurance system.
Amendment 197 #
Proposal for a directive
Article 7 – paragraph 5
Article 7 – paragraph 5
5. If the information supporting the application is inadequate, the time limit shall be suspended and the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 690 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 1590 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.
Amendment 206 #
Proposal for a directive
Article 7 – paragraph 6
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 3180 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) or suspended in accordance with the provisions of the preceding paragraph.
Amendment 222 #
Proposal for a directive
Article 8
Article 8