9 Amendments of Raffaele STANCANELLI related to 2023/0128(COD)
Amendment 28 #
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
2. Opposition may only be filed on the grounds that one or more of the conditions set out in Article 3 or 6 are not fulfilled for one or more of the designated Member States.
Amendment 29 #
Proposal for a regulation
Article 26 – paragraph 4 – point c a (new)
Article 26 – paragraph 4 – point c a (new)
(c a) any evidence that is relied upon by the opponent.
Amendment 30 #
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – 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 31 #
Proposal for a regulation
Article 26 – paragraph 7 – subparagraph 2
Article 26 – paragraph 7 – subparagraph 2
Amendment 32 #
Proposal for a regulation
Article 26 – paragraph 9
Article 26 – paragraph 9
9. 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 33 #
Proposal for a regulation
Article 26 – paragraph 10
Article 26 – paragraph 10
10. If the opposition panel considers that no ground for opposition prejudices the maintenancemore than one opposition is filed in respect of the same examination opinion, ithe Office shall rejecthear the opposition, and the Office shall mention this in the Registers jointly and issue a common decision.
Amendment 34 #
Proposal for a regulation
Article 26 – paragraph 11
Article 26 – paragraph 11
11. 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 35 #
Proposal for a regulation
Article 26 – paragraph 12 – subparagraph 1 (new)
Article 26 – paragraph 12 – subparagraph 1 (new)
Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
Amendment 47 #
Proposal for a regulation
Article 35 a (new)
Article 35 a (new)
Article 35a 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.