20 Amendments of Corinne LEPAGE related to 2012/0035(COD)
Amendment 62 #
Proposal for a directive
Recital 13
Recital 13
Amendment 67 #
Proposal for a directive
Recital 14
Recital 14
(14) The quality, safety and efficacy of medicinal products, including the bioequivalence of generic medicinal products with the reference product, are ascertained in the framework of marketing authorisation procedures. In the framework of pricing and reimbursement procedures, Member States should therefore not re- assess the elements on which the marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the medicinal product (quality, safety, efficacy or bioequivalence of the medicinal product). Member States shall be guaranteed full access to the data used by the marketing authorisation authority in assessing these elements, with a view to evaluating the relative safety, efficacy and effectiveness of the medicine in the context of the health insurance scheme. Competent authorities should also have the right to request additional data for the purpose of their evaluation.
Amendment 97 #
Proposal for a directive
Article 3 – paragraph 2 – subparagraph 1a (new)
Article 3 – paragraph 2 – subparagraph 1a (new)
This Article shall not prevent Member States to refuse repeated applications following a negative decision if the circumstances have not significantly changed.
Amendment 100 #
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 1530 days, provided that the price of the reference medicinal product has been approved by the competent authorities.
Amendment 108 #
Proposal for a directive
Article 3 – paragraph 4
Article 3 – paragraph 4
4. Member States shall establish in detail thethe categories of particulars and documents to be submitted by the applicant.
Amendment 114 #
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 1530 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 130 #
Proposal for a directive
Article 4 – paragraph 2 – subparagraph 1a (new)
Article 4 – paragraph 2 – subparagraph 1a (new)
This Article shall not prevent Member States to refuse repeated applications following a negative decision if the circumstances have not significantly changed.
Amendment 133 #
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 139 #
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 143 #
Proposal for a directive
Article 4 – paragraph 4 – subparagraph 1
Article 4 – paragraph 4 – subparagraph 1
Member States shall establish in detail thethe categories of particulars and documents to be submitted by the applicant.
Amendment 146 #
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 162 #
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 169 #
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 177 #
Proposal for a directive
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Member States shall ensure that an application to include a medicinal product in the scope of the public health insurance system can be introduced by the marketing authorisation holder at any point in time. If the public health insurance system comprises several schemes or categories of coverage, the marketing authorisation holder shall be entitled to apply for the inclusion of its product in the scheme or category of its choice. The competent authorities shall provide the applicant with an official acknowledgement of receipt.
Amendment 181 #
Proposal for a directive
Article 7 – paragraph 3
Article 7 – paragraph 3
3. Member States shall establish in detail thethe categories of particulars and documents to be submitted by the applicant.
Amendment 187 #
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 1530 days, provided that the reference medicinal product has already been included in the public health insurance system.
Amendment 198 #
Proposal for a directive
Article 7 – paragraph 5
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 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 1530 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 207 #
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 360 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).
Amendment 224 #
Proposal for a directive
Article 8
Article 8
Amendment 242 #
Proposal for a directive
Article 13
Article 13
In the framework of pricing and reimbursement decisions, Member States shall not re-assess the elements on which the marketing authorisation is based, including (the quality, safety, efficacy or bioequivalence of the medicinal product). Member States shall be guaranteed full access to the data used by the marketing authorisation authority in assessing these elements, with a view to evaluating the relative safety, efficacy and effectiveness of the medicine in the context of the health insurance scheme. Competent authorities should also have the right to request additional data for the purpose of their evaluation.