do-me/EUR-LEX huggingface dataset:
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 21 December 2020 to 21 December 2020 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 136, 30.4.2004, p. 1.)) 2020/C 447 I/01
Date: 2020-12-24
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: coronavirus disease, drug surveillance, market approval, marketing standard, vaccine








CI2020447EN.01000101.xml










24.12.2020   


EN


Official Journal of the European Union


CI 447/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 21 December 2020 to 21 December 2020


(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2020/C 447 I/01)






—



Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

















Date of the decision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




21.12.2020


Comirnaty


COVID-19 mRNA Vaccine (nucleoside modified)


BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland


EU/1/20/1528


Concentrate for dispersion for injection


J07BX


21.12.2020




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




Domenico Scarlattilaan 6




1083 HS Amsterdam




NETHERLANDS






(1)  OJ L 136, 30.4.2004, p. 1.
Case C-713/20: Request for a preliminary ruling from the Centrale Raad van Beroep (Netherlands) lodged on 24 December 2020 — Raad van bestuur van de Sociale verzekeringsbank, Y v X, Raad van bestuur van de Sociale verzekeringsbank
Date: 2020-12-24
Institutions: Court of Justice
Subjects: frontier worker, social security legislation, temporary employment, temporary employment agency, termination of employment, work contract








C_2021128EN.01001102.xml










12.4.2021   


EN


Official Journal of the European Union


C 128/11






Request for a preliminary ruling from the Centrale Raad van Beroep (Netherlands) lodged on 24 December 2020 — Raad van bestuur van de Sociale verzekeringsbank, Y v X, Raad van bestuur van de Sociale verzekeringsbank
(Case C-713/20)
(2021/C 128/16)
Language of the case: Dutch

Referring court

Centrale Raad van Beroep

Parties to the main proceedings


Appellants: Raad van bestuur van de Sociale verzekeringsbank, Y

Respondents: X, Raad van bestuur van de Sociale verzekeringsbank

Questions referred







1.


Must Article 11(3)(a) of Regulation (EC) No 883/2004 (1) be interpreted as meaning that a worker who resides in a Member State, and works in the territory of another Member State on the basis of a temporary agency contract, under which the employment relationship ends as soon as the temporary assignment ends and is then resumed again, remains subject to the legislation of the latter Member State during the intervening periods, so long as he has not temporarily ceased that work?










2.


What factors are relevant for assessing whether or not there is a temporary cessation of activity in such cases?










3.


How much time must elapse before a worker who is no longer in a contractual employment relationship is to be regarded as having temporarily ceased his activity in the country of employment, unless there are concrete indications to the contrary?






(1)  Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (OJ 2004 L 166, p. 1).
Case C-712/20: Request for a preliminary ruling from the Landgericht Köln (Germany) lodged on 24 December 2020 — GJ v Ryanair DAC
Date: 2020-12-24
Institutions: Court of Justice
Subjects: air transport, carriage of passengers, carrier, indemnification, strike, trade union, traveller








C_2021128EN.01001101.xml










12.4.2021   


EN


Official Journal of the European Union


C 128/11






Request for a preliminary ruling from the Landgericht Köln (Germany) lodged on 24 December 2020 — GJ v Ryanair DAC
(Case C-712/20)
(2021/C 128/15)
Language of the case: German

Referring court

Landgericht Köln

Parties to the main proceedings


Applicant: GJ

Defendant: Ryanair DAC

Question referred

Is a strike by the air carrier’s own employees that is called by a trade union an extraordinary circumstance within the meaning of Article 5(3) of Regulation (EC) No 261/2004? (1)



(1)  Regulation (EC) No 261/2004 of the European Parliament and of the Council of 11 February 2004 establishing common rules on compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights, and repealing Regulation (EEC) No 295/91 (OJ 2004 L 46, p. 1).