2 Amendments of Balázs HIDVÉGHI related to 2022/0031(COD)
Amendment 22 #
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4a) During 2021, around 2 million Union citizens were vaccinated by COVID-19 vaccines the distribution of which has been temporarily authorised pursuant to Article 5(2) of Directive 2001/83/EC of the European Parliament and of the Council1a. The emergence of Omicron variant considerably changed vaccination policies throughout the Union. Booster vaccination became indispensable to prevent severe diseases resulting from infection. For preventing severe diseases, it is important that everyone obtains booster vaccination and those persons who, during the primary course of vaccination, did not receive vaccines authorised under Regulation (EC) No 726/2004 are also assured that all their vaccination certificates should be recognized in case a booster vaccine is authorised under that Regulation. ____________________- 1a Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
Amendment 58 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b a (new)
Article 1 – paragraph 1 – point 3 – point b a (new)
Regulation (EU) 2021/953
Article 5 – paragraph 5 – subparagraph 3 b (new)
Article 5 – paragraph 5 – subparagraph 3 b (new)
(ba) in paragraph 5, the following subparagraph is added: “By derogation from the second subparagraph, Member States shall accept vaccination certificates issued by other Member States in accordance with this Regulation for a COVID-19 vaccine which has been temporarily authorised pursuant to Article 5(2) of Directive 2001/83/EC if the vaccine was administered before 31 December 2021 and has been followed by a booster COVID-19 vaccine that has been granted a marketing authorisation pursuant to Regulation (EC) No 726/2004.”;