17 Amendments of Raffaele STANCANELLI related to 2023/0127(COD)
Amendment 122 #
Proposal for a regulation
Article 15 – paragraph 4 – point c a (new)
Article 15 – paragraph 4 – point c a (new)
(c a) any evidence that is relied upon by the opponent.
Amendment 124 #
Proposal for a regulation
Article 15 – paragraph 6
Article 15 – paragraph 6
6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate this to the opponent with reasons as soon as practicable after the filing of the notice of opposition, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1.
Amendment 126 #
Proposal for a regulation
Article 15 – paragraph 8
Article 15 – paragraph 8
Amendment 128 #
Proposal for a regulation
Article 15 – paragraph 10
Article 15 – paragraph 10
10. The Office shall issue a decision on the opposition within 6 months, unless the complexity of the case requires a longer period. The decision shall include detailed reasons.
Amendment 131 #
Proposal for a regulation
Article 15 – paragraph 10 a (new)
Article 15 – paragraph 10 a (new)
10 a. If more than one opposition is filed in respect of the same examination opinion, the Office shall hear the oppositions jointly and issue a common decision.
Amendment 132 #
Proposal for a regulation
Article 15 – paragraph 12
Article 15 – paragraph 12
12. If the opposition panel considers that at least one ground for opposition prejudices the maintenance of the examination opinion, it shall adopt an amended opinion, and the Office shall mention thispublish its full decision in the Register.
Amendment 135 #
Proposal for a regulation
Article 15 – paragraph 13 a (new)
Article 15 – paragraph 13 a (new)
13 a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
Amendment 190 #
Proposal for a regulation
Article 35 – paragraph 1 – point i a (new)
Article 35 – paragraph 1 – point i a (new)
(i a) information on all direct financial support received for research related to the development of the product for which the unitary SPC is applied for.
Amendment 195 #
Proposal for a regulation
Article 35 – paragraph 1 – point k a (new)
Article 35 – paragraph 1 – point k a (new)
(k a) where applicable, any third party observation and any related documents;
Amendment 196 #
Proposal for a regulation
Article 35 – paragraph 1 – point l
Article 35 – paragraph 1 – point l
(l) where applicable,any documents from the examination procedure and the date and a summarcopy of the examination opinion relating to an application for an extension of the duration of a unitary certificate;
Amendment 197 #
Proposal for a regulation
Article 35 – paragraph 1 – point l
Article 35 – paragraph 1 – point l
(l) where applicable, the date and a summarcopy of the examination opinion relating to an application for an extension of the duration of a unitary certificate;
Amendment 201 #
Proposal for a regulation
Article 35 – paragraph 1 – point m
Article 35 – paragraph 1 – point m
(m) where applicable, the filing of an opposition, and thits status, any documents from the opposition procedure, the outcome outcome of the opposition proceedings, includinga copy of the decision and, where applicable a summarcopy of the revised examination opinion;
Amendment 202 #
Proposal for a regulation
Article 35 – paragraph 1 – point n
Article 35 – paragraph 1 – point n
(n) where applicable, the filing of an appeal, and the outcome of the appeal proceedings, includingits status, any documents from the appeal proceedings, outcome a copy of the decision and where applicable a summarcopy of the revised examination opinion;
Amendment 205 #
Proposal for a regulation
Article 35 – paragraph 1 – point r a (new)
Article 35 – paragraph 1 – point r a (new)
(r a) where applicable, the filing of an action to the General Court or the Court of Justice of the European Union, its status, a copy of the decision and where applicable a copy of the revised examination opinion;
Amendment 207 #
Proposal for a regulation
Article 35 – paragraph 1 – point r b (new)
Article 35 – paragraph 1 – point r b (new)
(r b) any documents and communications between the Office and any party in the proceedings.
Amendment 209 #
Proposal for a regulation
Article 35 – paragraph 7 – point b
Article 35 – paragraph 7 – point b
(b) maintaining the Register and making it available for inspection by public authorities and economic operators;
Amendment 212 #
Proposal for a regulation
Article 35 – paragraph 8 a (new)
Article 35 – paragraph 8 a (new)
8 a. The existence on the Register of a granted or applied for supplementary protection certificate shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products.