do-me/EUR-LEX huggingface dataset:
Corrigendum to Council Decision (CFSP) 2022/1272 of 21 July 2022 amending Decision 2014/145/CFSP concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine (Official Journal of the European Union L 193 of 21 July 2022)
Date: 2022-08-04
Institutions: Council of the European Union
Subjects: EU restrictive measure, Russia, Ukraine, economic sanctions, international sanctions, legal person, natural person, territorial dispute, territorial law








L_2022204EN.01001801.xml










4.8.2022   


EN


Official Journal of the European Union


L 204/18







Corrigendum to Council Decision (CFSP) 2022/1272 of 21 July 2022 amending Decision 2014/145/CFSP concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine

(
Official Journal of the European Union L 193 of 21 July 2022
)


On page 252, in entry number 1209 for Alexander Anatolievich MAKSIMTSEV, in the third column headed ‘Identifying information’:
for:


                  ‘POB: Tokmak, Kirghiz SSR, former USSR (now Russian Federation)’,

read:


                  ‘POB: Tokmak, Kirghiz SSR, former USSR (now Kyrgyzstan)’.
Case T-483/22: Action brought on 4 August 2022 — Genzyme Europe v Commission
Date: 2022-08-04
Institutions: General Court
Subjects: drug surveillance, drugs classification, market approval, orphan drug








C_2022408EN.01003601.xml










24.10.2022   


EN


Official Journal of the European Union


C 408/36






Action brought on 4 August 2022 — Genzyme Europe v Commission
(Case T-483/22)
(2022/C 408/48)
Language of the case: English

Parties


Applicant: Genzyme Europe BV (Amsterdam, Netherlands) (represented by: P. Bogaert, B. Van Vooren and M. Oyarzabal Arigita, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:






—


annul the decision that avalglucosidase alfa does not qualify as a ‘new active substance’, as contained in, or at least implied by, Commission Decision C(2022) 4531 final of 24 June 2022;










—


annul Article 5 of that Commission Decision, providing that the medicinal product Nexviadyme — avalglucosidase alfa shall not be classified as an orphan medicinal product; and










—


order the European Commission to pay the costs of these proceedings.





Pleas in law and main arguments

In support of the action, the applicant relies on three pleas in law.






1.


First plea in law, alleging a breach of Article 10(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 (1) and of Article 14(11) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 (2) and a manifest error of assessment, combined with inadequate statement of reasons (against the first part of the contested decision, refusing the status of ‘new active substance’).










2.


Second plea in law, alleging breach of the principle of good administration, as enshrined in Article 41 of the Charter of Fundamental Rights of the European Union (against the first part of the contested decision, refusing the status of ‘new active substance’).










3.


Third plea in law, alleging breach of Article 5(12)(b) of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products, (3) manifest error of assessment and inadequate statement of reasons (against the second part of the contested decision — withdrawal of orphan designation).






(1)  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 2001 L 311, p. 67), as amended.

(2)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1), as amended.

(3)  Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1), as amended.
Case C-523/22: Request for a preliminary ruling from the Apelativen sad Veliko Tarnovo (Bulgaria) lodged on 4 August 2022 — UT v SO
Date: 2022-08-04
Institutions: Court of Justice
Subjects: bank deposit, banking supervision, credit, credit institution, financial supervision, trade licence








C_2022424EN.01002702.xml










7.11.2022   


EN


Official Journal of the European Union


C 424/27






Request for a preliminary ruling from the Apelativen sad Veliko Tarnovo (Bulgaria) lodged on 4 August 2022 — UT v SO
(Case C-523/22)
(2022/C 424/36)
Language of the case: Bulgarian

Referring court

Apelativen sad Veliko Tarnovo

Parties to the main proceedings


Defendant: UT

Private prosecutor and civil claimant: SO

Questions referred







1.


Is the definition of a credit institution in Article 4(1)(1) of Regulation (EU) No 575/2013 (1) of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 to be interpreted as meaning that credit is to be granted exclusively from funds received from the public as deposits or other repayable funds, or may a credit institution also grant credit from funds from other sources?










2.


How is the content of the ‘instrument … in any form … by which the right to carry out the business is granted’ within the meaning of Article 4(1)(42) of Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 to be interpreted, and does it include both the authorisation scheme and the registration scheme which grant approval for credit operations?






(1)  OJ 2013 L 176, p. 1.
Case T-279/22 R: Order of the President of the General Court of 4 August 2022 — Biogen Netherlands v Commission (Interim relief — Medicinal products for human use — Regulation (EC) No 726/2004 — Marketing authorisation for Dimethyl fumarate Mylan — dimethyl fumarate — Application for suspension of operation of a measure — No urgency)
Date: 2022-08-04
Institutions: General Court
Subjects: drug surveillance, generic drug, market approval








C_2022398EN.01002702.xml










17.10.2022   


EN


Official Journal of the European Union


C 398/27






Order of the President of the General Court of 4 August 2022 — Biogen Netherlands v Commission
(Case T-279/22 R)
(Interim relief - Medicinal products for human use - Regulation (EC) No 726/2004 - Marketing authorisation for Dimethyl fumarate Mylan - dimethyl fumarate - Application for suspension of operation of a measure - No urgency)
(2022/C 398/33)
Language of the case: English

Parties


Applicant: Biogen Netherlands BV (Badhoevedorp, Netherlands) (represented by: C. Schoonderbeek, lawyer)

Defendant: European Commission (represented by: L. Haasbeek and A. Sipos, acting as Agents)

Re:

By its application based on Articles 278 and 279 TFEU, the applicant seeks suspension of the operation of Commission Implementing Decision C(2022) 3252 final of 13 May 2022 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Dimethyl fumarate Mylan — dimethyl fumarate’ as a medicinal product for human use.

Operative part of the order







1.


The application for interim measures is dismissed.










2.


The costs are reserved.
Case T-278/22 R: Order of the President of the General Court of 4 August 2022 — Biogen Netherlands v Commission (Interim relief — Medicinal products for human use — Regulation (EC) No 726/2004 — Marketing authorisation for Dimethyl fumarate Neuraxpharm — dimethyl fumarate — Application for suspension of operation of a measure — No urgency)
Date: 2022-08-04
Institutions: General Court
Subjects: drug surveillance, generic drug, market approval








C_2022398EN.01002701.xml










17.10.2022   


EN


Official Journal of the European Union


C 398/27






Order of the President of the General Court of 4 August 2022 — Biogen Netherlands v Commission
(Case T-278/22 R)
(Interim relief - Medicinal products for human use - Regulation (EC) No 726/2004 - Marketing authorisation for Dimethyl fumarate Neuraxpharm - dimethyl fumarate - Application for suspension of operation of a measure - No urgency)
(2022/C 398/32)
Language of the case: English

Parties


Applicant: Biogen Netherlands BV (Badhoevedorp, Netherlands) (represented by: C. Schoonderbeek, lawyer)

Defendant: European Commission (represented by: L. Haasbeek and A. Sipos, acting as Agents)

Re:

By its application based on Articles 278 and 279 TFEU, the applicant seeks suspension of the operation of Commission Implementing Decision C(2022) 3254 final of 13 May 2022 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Dimethyl fumarate Neuraxpharm — dimethyl fumarate’ as a medicinal product for human use.

Operative part of the order







1.


The application for interim measures is dismissed.










2.


The costs are reserved.
Case C-522/22: Request for a preliminary ruling from the Landgericht Frankfurt am Main (Germany) lodged on 4 August 2022 — GE v British Airways Plc
Date: 2022-08-04
Institutions: Court of Justice
Subjects: air transport, carriage of passengers, carrier, consumer protection, indemnification, ticket, traveller








C_2022389EN.01000901.xml










10.10.2022   


EN


Official Journal of the European Union


C 389/9






Request for a preliminary ruling from the Landgericht Frankfurt am Main (Germany) lodged on 4 August 2022 — GE v British Airways Plc
(Case C-522/22)
(2022/C 389/11)
Language of the case: German

Referring court

Landgericht Frankfurt am Main

Parties to the main proceedings


Applicant: GE

Defendant: British Airways Plc

Questions referred







1.


Must Article 8(1)(a) of Regulation (EC) No 261/2004, (1) in conjunction with Article 7(3) thereof, be interpreted as meaning that a passenger who has paid for a flight partly in frequent flyer miles may claim from the operating air carrier, which is not his or her contracting partner, reimbursement (only) in frequent flyer miles in that respect?










2.


In the event that the Court answers the first question in the affirmative:
Does Regulation No 261/2004 preclude national legislation under which, in the event of failure to provide reimbursement in the form of frequent flyer miles, contrary to the corresponding obligation under Article 8(1)(a) of that regulation, compensation in lieu of performance may be claimed from the operating air carrier, or is the passenger bound by his or her original request for reimbursement in frequent flyer miles?










3.


In the event that the Court answers the first question in the negative:
In the event that the passenger may also claim reimbursement in money or is reimbursed in money, must Article 8(1)(a) of Regulation No 261/2004, in conjunction with Article 7(3) thereof, be interpreted as meaning that, as reimbursement of the cost of the ticket (…) at the price at which it was bought, the passenger is reimbursed by the operating air carrier the amount in money which would enable, or would have enabled, him or her to purchase, without using frequent flyer miles, re-routing, under comparable transport conditions, to his or her final destination at the earliest opportunity or at a later date at his or her convenience, subject to availability of seats?






(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).
Euro exchange rates (Source: reference exchange rate published by the ECB.) 3 August 2022 2022/C 297/02
Date: 2022-08-04
Institutions: European Commission
Subjects: euro, exchange rate, money








C_2022297EN.01000301.xml










4.8.2022   


EN


Official Journal of the European Union


C 297/3






Euro exchange rates (1)

3 August 2022
(2022/C 297/02)

1 euro =











 


Currency


Exchange rate




USD


US dollar


1,0194 




JPY


Japanese yen


136,18 




DKK


Danish krone


7,4427 




GBP


Pound sterling


0,83629 




SEK


Swedish krona


10,3913 




CHF


Swiss franc


0,9773 




ISK


Iceland króna


139,30 




NOK


Norwegian krone


9,8743 




BGN


Bulgarian lev


1,9558 




CZK


Czech koruna


24,650 




HUF


Hungarian forint


395,03 




PLN


Polish zloty


4,6910 




RON


Romanian leu


4,9245 




TRY


Turkish lira


18,3112 




AUD


Australian dollar


1,4681 




CAD


Canadian dollar


1,3085 




HKD


Hong Kong dollar


8,0022 




NZD


New Zealand dollar


1,6266 




SGD


Singapore dollar


1,4069 




KRW


South Korean won


1 336,03 




ZAR


South African rand


17,1283 




CNY


Chinese yuan renminbi


6,8830 




HRK


Croatian kuna


7,5178 




IDR


Indonesian rupiah


15 184,35 




MYR


Malaysian ringgit


4,5435 




PHP


Philippine peso


56,855 




RUB


Russian rouble


 




THB


Thai baht


36,963 




BRL


Brazilian real


5,3547 




MXN


Mexican peso


21,0788 




INR


Indian rupee


80,6895 






(1)  Source: reference exchange rate published by the ECB.
State aid – Decision to raise no objections 2022/C 297/04
Date: 2022-08-04
Institutions: EFTA Surveillance Authority
Subjects: European Economic Area, Norway, State aid, control of State aid, reduction of gas emissions, tax relief








C_2022297EN.01000501.xml










4.8.2022   


EN


Official Journal of the European Union


C 297/5






State aid – Decision to raise no objections
(2022/C 297/04)
The EFTA Surveillance Authority raises no objections to the following state aid measures:






Date of adoption of the decision


6 April 2022




Case No


88307




Decision No


068/22/COL




EFTA State


Norway




Title (and/or name of the beneficiary)


State aid measures in favour of zero-emission vehicles (ZEVs)




Legal basis


The re-registration tax measure is laid down in Parliament’s decision concerning re-registration tax
The favourable income tax calculation is laid down in the Norwegian Tax Act of 26 March 1999 No 14 and the Ministry’s supplementing Regulation of 19 November 1999 No 1158




Type of measure


Aid scheme




Objective


Environmental aid




Form of aid


Tax rate reduction (re-registration tax); tax base reduction (favourable income tax calculation)




Budget


Unaltered




Intensity


Re-registration tax: 75 %
Favourable income tax calculation: 20 %




Duration


Until 31 December 2023 for the re-registration tax measure. No limitation in time for the favourable income tax calculation




Economic sectors


Manufacture of motor vehicles




Name and address of the granting authority







The Ministry of Finance




P.O.Box 8008 Dep




N-0030 Oslo




NORWAY








The authentic text of the decision, from which all confidential information has been removed, can be found on the EFTA Surveillance Authority’s Internet:
http://www.eftasurv.int/state-aid/state-aid-register/decisions/
State aid – Decision to raise no objections 2022/C 297/03
Date: 2022-08-04
Institutions: EFTA Surveillance Authority
Subjects: European Economic Area, Iceland, State aid, aid to undertakings, control of State aid, coronavirus disease, epidemic, package travel








C_2022297EN.01000401.xml










4.8.2022   


EN


Official Journal of the European Union


C 297/4






State aid – Decision to raise no objections
(2022/C 297/03)
The EFTA Surveillance Authority raises no objections to the following state aid measure:






Date of adoption of the decision


5 April 2022




Case No


88473




Decision No


071/22/COL




EFTA State


Iceland




Title (and/or name of the beneficiary)


COVID-19 – Amendment to the travel guarantee fund for package travel traders




Legal basis


An amendment to Act No 78/2020 on Package Travel and Linked Travel Arrangement




Type of measure


Scheme




Objective


Remedy for a serious disturbance in the economy




Form of aid


Interest rate subsidy




Budget


ISK 4,5 billion




Duration


2.7.2020 – 31.12.2020




Economic sectors


NACE 79 - Travel agency, tour operator and other reservation service and related activities




Name and address of the granting authority







Ferðamálastofa




Hafnarstræti 91




600 Akureyri




ICELAND








The authentic text of the decision, from which all confidential information has been removed, can be found on the EFTA Surveillance Authority’s Internet: http://www.eftasurv.int/state-aid/state-aid-register/decisions/
Corrigendum to Council Implementing Regulation (EU) 2022/1270 of 21 July 2022 implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine (Official Journal of the European Union L 193 of 21 July 2022)
Date: 2022-08-04
Institutions: Council of the European Union
Subjects: EU restrictive measure, Russia, Ukraine, economic sanctions, international sanctions, legal person, natural person, territorial dispute, territorial law








L_2022204EN.01001701.xml










4.8.2022   


EN


Official Journal of the European Union


L 204/17







Corrigendum to Council Implementing Regulation (EU) 2022/1270 of 21 July 2022 implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine

(
Official Journal of the European Union L 193 of 21 July 2022
)


On page 162, in entry number 1209 for Alexander Anatolievich MAKSIMTSEV, in the third column headed ‘Identifying information’:
for:


                  ‘POB: Tokmak, Kirghiz SSR, former USSR (now Russian Federation)’,

read:


                  ‘POB: Tokmak, Kirghiz SSR, former USSR (now Kyrgyzstan)’.
Corrigendum to Council Decision (CFSP) 2022/1313 of 25 July 2022 amending Decision 2014/512/CFSP concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine (Official Journal of the European Union L 198 of 27 July 2022)
Date: 2022-08-04
Institutions: Council of the European Union
Subjects: EU restrictive measure, Russia, Ukraine, economic sanctions, international sanctions, territorial dispute, territorial law, trade restriction








L_2022204EN.01001601.xml










4.8.2022   


EN


Official Journal of the European Union


L 204/16







Corrigendum to Council Decision (CFSP) 2022/1313 of 25 July 2022 amending Decision 2014/512/CFSP concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine

(
Official Journal of the European Union L 198 of 27 July 2022
)


In the title on the Contents Page, and on page 17 in the title and in the signature:
for:


                  ’
                  25 July 2022
                  ’,

read:


                  ’
                  26 July 2022
                  ’.
Council Implementing Regulation (EU) 2022/1356 of 4 August 2022 implementing Regulation (EU) No 101/2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Tunisia
Date: 2022-08-04
Institutions: Council of the European Union
Subjects: EU restrictive measure, Tunisia, economic sanctions, international sanctions, natural person








L_2022205EN.01000101.xml










5.8.2022   


EN


Official Journal of the European Union


L 205/1








            COUNCIL IMPLEMENTING REGULATION (EU) 2022/1356
of 4 August 2022
         
implementing Regulation (EU) No 101/2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Tunisia


THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Council Regulation (EU) No 101/2011 of 4 February 2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Tunisia (1), and in particular Article 12 thereof,


Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:







(1)


On 4 February 2011, the Council adopted Regulation (EU) No 101/2011.












(2)


On the basis of a review by the Council, the entry for one person and the information regarding his rights of defence and his right to effective judicial protection should be deleted.












(3)


Annex I to Regulation (EU) No 101/2011 should therefore be amended accordingly,





HAS ADOPTED THIS REGULATION:



Article 1
Annex I to Regulation (EU) No 101/2011 is amended as set out in the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 August 2022.


For the Council


The President

M. BEK
            





(1)  
            OJ L 31, 5.2.2011, p. 1.




ANNEX
Annex I to Regulation (EU) No 101/2011 is amended as follows:






(1)


in Section A (‘List of persons and entities referred to in Article 2’), the entry for the following person is deleted:






‘45.


Montassar Ben Habib Ben Bouali LTAIEF’;














(2)


in Section B (‘Rights of defence and right to effective judicial protection under Tunisian law:’), the following entry is deleted:






‘45.


Montassar Ben Habib Ben Bouali LTAIEF
The investigation or trial relating to the misappropriation of public funds or assets is still ongoing. The information on the Council’s file shows that the rights of defence and the right to effective judicial protection were respected in the judicial proceedings on which the Council relied. This is demonstrated in particular by the fact that in 2011 and 2013 Mr Montassar Ben Habib Ben Bouali LTAIEF was heard by an investigating judge in the presence of his lawyers.’.
Case T-269/22 R: Order of the President of the General Court of 4 August 2022 — Biogen Netherlands v Commission (Interim relief — Medicinal products for human use — Regulation (EC) No 726/2004 — Marketing authorisation for Dimethyl fumarate Polpharma — dimethyl fumarate — Application for suspension of operation of a measure — No urgency)
Date: 2022-08-04
Institutions: General Court
Subjects: drug surveillance, generic drug, market approval








C_2022398EN.01002602.xml










17.10.2022   


EN


Official Journal of the European Union


C 398/26






Order of the President of the General Court of 4 August 2022 — Biogen Netherlands v Commission
(Case T-269/22 R)
(Interim relief - Medicinal products for human use - Regulation (EC) No 726/2004 - Marketing authorisation for Dimethyl fumarate Polpharma - dimethyl fumarate - Application for suspension of operation of a measure - No urgency)
(2022/C 398/31)
Language of the case: English

Parties


Applicant: Biogen Netherlands BV (Badhoevedorp, Netherlands) (represented by: C. Schoonderbeek, lawyer)

Defendant: European Commission (represented by: L. Haasbeek and A. Sipos, acting as Agents)

Re:

By its application based on Articles 278 and 279 TFEU, the applicant seeks suspension of the operation of Commission Implementing Decision C(2022) 3253 final of 13 May 2022 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Dimethyl fumarate Polpharma — dimethyl fumarate’ as a medicinal product for human use.

Operative part of the order







1.


The application for interim measures is dismissed.










2.


The costs are reserved.