ddrg/super_eurlex huggingface dataset:
Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2020 to 30 September 2020

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2020/C 367/03)

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision Name(s) of the medicinal product INN (International Non-Proprietary Name) Holder(s) of the marketing authorization Member State concerned Date of notification 16.9.2020 Dinolytic 12,5 mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof Dinoprost See Annex II See Annex II 18.9.2020

— Suspension of a national marketing authorization

Date of the decision Name(s) of the medicinal product INN (International Non-Proprietary Name) Holder(s) of the marketing authorization Member State concerned Date of notification 24.9.2020 medicinal products for human use which have been authorised or are pending approval based on clinical trials performed at Panexcell Clinical Laboratories Priv. Ltd medicinal products for human use which have been authorised or are pending approval based on clinical trials performed at Panexcell Clinical Laboratories Priv. Ltd See Annex I See Annex I 25.9.2020

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.
‘(26)

Undertakings in difficulty are excluded from the scope of these Guidelines, subject to the exceptions set out in this point. The Commission considers that when an undertaking is in financial difficulty, given that its very existence is in danger, it cannot be considered an appropriate vehicle for promoting other public policy objectives until such time as its viability is assured. Therefore, where the beneficiary of the aid is in financial difficulty within the meaning of point (35)15, the aid will be assessed in accordance with the Community Guidelines on State aid for rescuing and restructuring firms in difficulty, as amended or replaced. This principle does not apply to compensatory aid for damage caused by natural disasters and exceptional occurrences referred to in Sections 1.2.1.1 and 2.1.3 of Part II of these Guidelines which is compatible with the internal market under Article 107(2)(b) of the Treaty. If the financial difficulty of an undertaking active in the agricultural and forestry sectors has been caused by the risk event referred to in Sections 1.2.1.2, 1.2.1.3, 1.2.1.5, 2.1.3, 2.8.1 or 2.8.5 of Part II of these Guidelines, aid to compensate for or restore the losses or damage caused by such risk events and to cover the costs of eradication of plant pests can be granted in line with these Guidelines and may be still found compatible with the internal market under Article 107(3)(c) of the Treaty. In addition, for reasons of public health protection and having in mind the emergency situation, no distinction should be made, under certain conditions, as to the economic situation of an undertaking for aid for destruction and removal of fallen stock in Section 1.2.1.4 and for aid for control and eradication measures in the case of animal diseases referred to in point (375) of Section 1.2.1.3 of Part II of these Guidelines. Moreover, undertakings that were not in difficulty on 31 December 2019 but became undertakings in difficulty in the period from 1 January 2020 until 30 June 2021 remain eligible for aid under these Guidelines.’.
Commission notice on current State aid recovery interest rates and reference/discount rates applicable as from 1 January 2021

(Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 of 21 April 2004 (OJ L 140, 30.4.2004, p. 1))

(2020/C 447/04)

Base rates calculated in accordance with the Communication from the Commission on the revision of the method for setting the reference and discount rates (OJ C 14, 19.1.2008, p. 6.). Depending on the use of the reference rate, the appropriate margins have still to be added as defined in this communication. For the discount rate this means that a margin of 100 basispoints has to be added. The Commission Regulation (EC) No 271/2008 of 30 January 2008 amending Regulation (EC) No 794/2004 foresees that, unless otherwise provided for in a specific decision, the recovery rate will also be calculated by adding 100 basispoints to the base rate.

Modified rates are indicated in bold.

Previous table published in OJ C 436, 17.12.2020, p. 29.
Corrigendum to Commission Notice - Technical guidance on the climate proofing of infrastructure in the period 2021-2027

( Official Journal of the European Union C 373 of 16 September 2021 )

(2022/C 246/09)

On page 1, in the disclaimer, fourth paragraph,

for:

‘The guidance is also deemed a relevant reference for the climate proofing of infrastructure under Article 2(37) and Article 67(3) j) of Regulation (EU) 2021/1060 of the European Parliament and of the Council (Common Provisions Regulation (CPR)) as well as under the Recovery and Resilience Facility.’,

read:

‘The guidance is also deemed a relevant reference for the climate proofing of infrastructure under Article 2(37) and Article 67(3) j) of Regulation (EU) 2021/1060 of the European Parliament and of the Council (Common Provisions Regulation (CPR)) as well as under the Recovery and Resilience Facility, and for climate proofing under Article 5(5) of Regulation (EU) 2021/1119 of the European Parliament and of the Council (European Climate Law) (OJ L 243, 9.7.2021, p. 1).’.

On page 13, in footnote 10,

for:

‘Certain infrastructure is designated “critical infrastructure” in accordance with Council Directive 2008/114/EC of 8 December 2008 on the identification and designation of European critical infrastructures and the assessment of the need to improve their protection (OJ L 345, 23.12.2008, p. 7) includes the following definition. This guidance on climate proofing can be applied to infrastructure irrespective of whether it is designated “critical infrastructure” or not.’,

read:
Information from the Commission pursuant to Council Decision (EU) 2020/1421

(2021/C 24/13)

Pursuant to Article 3 of Council Decision (EU) 2020/1421 of 1 October 2020 on the position to be taken on behalf of the European Union as regards amendments to the Annexes to the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) and to the Regulations annexed to the European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways (ADN) (1), the Commission informs that the decisions taken at the respective bodies are available at:

https://treaties.un.org/doc/Publication/CN/2020/CN.438.2020-Eng.pdf

https://treaties.un.org/doc/Publication/CN/2020/CN.461.2020-Eng.pdf and

https://treaties.un.org/doc/Publication/CN/2020/CN.546.2020-Eng.pdf

(1) OJ L 329, 9.10.2020, p. 1.
Commission notice on current State aid recovery interest rates and reference/discount rates applicable as from 1 February 2021

(Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 of 21 April 2004 (OJ L 140, 30.4.2004, p. 1))

(2021/C 30/04)

Base rates calculated in accordance with the Communication from the Commission on the revision of the method for setting the reference and discount rates (OJ C 14, 19.1.2008, p. 6). Depending on the use of the reference rate, the appropriate margins have still to be added as defined in this communication. For the discount rate this means that a margin of 100 basis points has to be added. The Commission Regulation (EC) No 271/2008 of 30 January 2008 amending Regulation (EC) No 794/2004 foresees that, unless otherwise provided for in a specific decision, the recovery rate will also be calculated by adding 100 basis points to the base rate.

Modified rates are indicated in bold.

Previous table published in OJ C 447, 23.12.2020, p. 9.
Official Journal of the European Union

Explanatory Notes to the Combined Nomenclature of the European Union

(2021/C 58 I/05)

Pursuant to Article 9(1)(a) of Council Regulation (EEC) No 2658/87 (1), the Explanatory Notes to the Combined Nomenclature of the European Union (2) are hereby amended as follows:

On page 386, the following text and photos are added:

‘Additional note 2 See also Note 6 to Chapter 90 and the judgment in Joined Cases C-260/00 to C-263/00, Lohmann GmbH & Co. KG and Medi Bayreuth Weihermüller & Voigtmann GmbH & Co. KG v Oberfinanzdirektion Koblenz, paragraphs 36, 37, 39, 40, 43 and 45, (ECLI:EU:C:2002:637). Examples of products falling under subheading 9021 10 10: Examples of products falling under Section XI: ’

On page 389: The existing explanatory note to subheading 9021 10 10 is replaced by the following text:

‘9021 10 10 Orthopaedic appliances See the explanatory note to Additional note 2 to Chapter 90.’

(1) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

(2) OJ C 119, 29.3.2019, p. 1.
COVID – 19 outbreak

(Regulation (EU) 2021/267 of the European Parliament and of the Council of 16 February 2021 laying down specific and temporary measures in view of the persistence of the COVID-19 crisis concerning the renewal or extension of certain certificates, licences and authorisations, the postponement of certain periodic checks and periodic training in certain areas of transport legislation and the extension of certain periods referred to in Regulation (EU) 2020/698 (1) )

(2021/C 76 I/14)

Hungary

Date of the Information to the Commission: 1.3.2021

Hungary has decided, in conformity with the relevant provisions of Regulation (EU) 2021/267 of the European Parliament and of the Council that it shall not apply the following provisions:

— Article 5(1) concerning the time limits for the periodic roadworthiness tests for motor vehicles and their trailers under Directive 2014/45/EU (2);

— Article 5(2) concerning the validity of roadworthiness certificates under Directive 2014/45/EU;

— Article 12(1) concerning the time limits for the performance of a regular review under Directive 2012/34/EU (3);

— Article 12(2) concerning the validity of temporary licences under Directive 2012/34/EU.

(1) OJ L 60, 22.2.2021, p. 1.

(2) Directive 2014/45/EU of the European Parliament and of the Council of 3 April 2014 on periodic roadworthiness tests for motor vehicles and their trailers and repealing Directive 2009/40/EC (OJ L 127, 29.4.2014, p. 51).

(3) Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (OJ L 343, 14.12.2012, p. 32).
Official Journal of the European Union

Types of gas and the corresponding supply pressures according to Article 4(1) of Regulation (EU) 2016/426 of the European Parliament and of the Council on appliances burning gaseous fuels and repealing Directive 2009/142/EC

(This publication is based on information received by the Commission from the Member States)

(2021/C 78/05)

GERMANY

Gas family 2nd family 3rd family Gas group Group H Group L Group P Group B Min. Max. Min. Max. Min. Max. Min. Max. Gross Calorific Value (GCV) [MJ/m3] 34,5 44,7 28,7 38,6 101,2 (4) 133,8 (4) Wobbe index [MJ/m3] 46,50 (1) 53,60 37,60 (2) 44,40 72,90 (5) 87,30 (5) 81,80 87,30 Gas composition by volume as % of the total content: C1 to C5 content (total) - 100 - 100 - 100 - 100 N2 + CO2 content 2,5 4 - - - CO content - - - - Unsaturated hydrocarbons content - - 10% 10% Hydrogen content 0 0,2 - 10 0 0,2 - 10 0 0,2 (6) 0 0,2 (6) Information on the toxic components contained in the gaseous fuel - H2S and COS: 5 mg/m3 - H2S and COS: 5 mg/m3 - H2S: technically free/ S from COS: 5 mg/kg - H2S: technically free / S from COS: 5 mg/kg Supply pressure: Minimum Nominal Maximum Minimum Nominal Maximum Minimum Nominal Maximum Minimum Nominal Maximum Supply pressure at the inlet of appliances [mbar] 18 20 25 18 20 25 42,5 25 50 (7) 30 (8) 57,5 35 42,5 50 57,5 Supply pressure at the point of delivery [mbar] 20 23 25,3 20 23 25,3 47,5 30 50 30 57,5 40 42,5 50 57,5 Admissible pressure loss in the end-user gas installation [mbar] 3 (3) 3 (3) 5 (3) 5 (3) Reference conditions for Wobbe Index and Gross Calorific Value: Combustion reference temperature [°C] 15oC Volume measurement reference temperature [°C] 15oC Volume measurement reference pressure [mbar] 1 013,25 mbar

(1) Group H: For suitable gas appliances (e.g. appliance category I2E), shortfalls in the Wobbe index down to WS,n = 43,2 MJ/m3 (12,0 kWh/m3) can be tolerated for limited periods of time in order to avoid supply shortages, with the appliance setting remaining unchanged at WS,n = 54,0 MJ/m3 (15,0 kWh/m3). (40,95 MJ/m3 (15oC)).

(2) Group L: For suitable gas appliances (e.g. appliance category I2ELL), shortfalls in the Wobbe index down to WS,n = 36,0 MJ/m3 (10,0 kWh/m3) can be tolerated for limited periods of time in order to use natural gases which are rich in inert gases, with the appliance setting remaining unchanged at WS,n = 44,6 MJ/m3 (12,4 kWh/m3). (34,13 MJ/m3 (15oC )).

(3) Domestic or similar use, as well as uses specified in footnotes (g) and (h); deviations possible for commerce or industry.

(4) Nominal.

(5) Only from stationary tank.

(6) Hydrogen, nitrogen, oxygen and methane.

(7) For gas appliances in domestic or commercial use, and gas appliances in commercial use in vehicles.

(8) For gas appliances in caravans, camper vans and boats, as well as gas appliances in commercial use in vehicles .
COVID-19 outbreak

(Regulation (EU) 2021/267 of the European Parliament and of the Council of 16 February 2021 laying down specific and temporary measures in view of the persistence of the COVID-19 crisis concerning the renewal or extension of certain certificates, licences and authorisations, the postponement of certain periodic checks and periodic training in certain areas of transport legislation and the extension of certain periods referred to in Regulation (EU) 2020/698 (1))

(2021/C 76 I/12)

Austria

Date of the Information to the Commission: 1.3.2021

Austria has decided, in conformity with the relevant provisions of Regulation (EU) 2021/267 of the European Parliament and of the Council that it shall not apply the following provisions:

— Article 4(1) concerning the regular inspections of tachographs in road transport under Regulation (EU) No 165/2014 (2);

— Article 4(2) concerning the renewal of driver cards under Regulation (EU) No 165/2014;

— Article 4(3) concerning the replacement of driver cards under Regulation (EU) No 165/2014;

— Article 5(1) concerning the time limits for the periodic roadworthiness tests for motor vehicles and their trailers under Directive 2014/45/EU (3);

— Article 5(2) concerning the validity of roadworthiness certificates under Directive 2014/45/EU;

— Article 11(1) concerning the renewal of licences of train drivers under Directive 2007/59/EC (4);

— Article 11(2) concerning the time limits for the completion of periodic checks of train drivers under Directive 2007/59/EC.

(1) OJ L 60, 22.2.2021, p. 1.

(2) Regulation (EU) No 165/2014 of the European Parliament and of the Council of 4 February 2014 on tachographs in road transport, repealing Council Regulation (EEC) No 3821/85 on recording equipment in road transport and amending Regulation (EC) No 561/2006 of the European Parliament and of the Council on the harmonisation of certain social legislation relating to road transport (OJ L 60, 28.2.2014, p. 1).

(3) Directive 2014/45/EU of the European Parliament and of the Council of 3 April 2014 on periodic roadworthiness tests for motor vehicles and their trailers and repealing Directive 2009/40/EC (OJ L 127, 29.4.2014, p. 51).

(4) Directive 2007/59/EC of the European Parliament and of the Council of 23 October 2007 on the certification of train drivers operating locomotives and trains on the railway system in the Community (OJ L 315, 3.12.2007, p. 51).
Commission information notice pursuant to Article 16(4) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community

Establishment of public service obligations in respect of scheduled air services

(Text with EEA relevance)

(2021/C 104/05)

Member State Spain Route concerned Menorca-Madrid Reopening date of the PSO routes to community air carriers 1.5.2021 Address where the text and any other information or documentation related to the public service obligations can be obtained. Ministerio de Transportes, Movilidad y Agenda Urbana Dirección General de Aviación Civil Subdirección General de Transporte Aéreo Paseo de la Castellana 67 28071 Madrid ESPAÑA Tel. +34 915977837 Fax +34 915978643 Email: osp.dgac@mitma.es

The routes subject to public service obligations may be operated on the basis of free competition access as from 1 May 2021. In the event that no air carrier submits a program of services compliant with the public service obligations imposed, access will be restricted from 1 November 2021 to 30 April 2022 to a single air carrier through the corresponding public tender procedure, in accordance with Article 16(9) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council (1).

(1) OJ L 293, 31.10.2008, p. 3.
Official Journal of the European Union

Winding-Up Proceedings

Winding-up proceedings in respect of Insurance company ‘EUROAMERICAN’ JSC

Publication made in accordance with Article 280 of Directive 2009/138/EC of the European Parliament and of the Council on the taking up and pursuit of the business of Insurance and Reinsurance (Solvency II)

(2021/C 133/07)
Official Journal of the European Union

COMMUNICATION FROM THE COMMISSION

in pursuance of Article 4 of Directive 2000/84/EC of the European Parliament and of the Council on summer-time arrangements

Schedule for the summer-time period

(2021/C 149/01)

For 2022-2026 inclusive, the summer-time periods will begin and end respectively on the following dates at 1.00 a.m. UTC – Coordinated Universal Time:

— in 2022: the Sundays of 27 March and 30 October,

— in 2023: the Sundays of 26 March and 29 October,

— in 2024: the Sundays of 31 March and 27 October,

— in 2025: the Sundays of 30 March and 26 October,
Official Journal of the European Union

List of customs offices empowered to handle formalities for the exportation of cultural goods, published in accordance with Article 5(2) of Council Regulation (EC) No 116/2009 (1)

(2021/C 184/09)

Member State Name of customs Region (if applicable) BELGIUM All customs offices BULGARIA All customs offices CZECH REPUBLIC All customs offices DENMARK All customs offices GERMANY All customs offices ESTONIA All customs offices IRELAND All customs offices GREECE 1) Customs office of Athens, 12th km of national road Athens-Lamia (A1) 144 10 Metamorphosi 2) 1st Customs Office of Thessaloniki, Port of Thessaloniki 54110 Thessaloniki SPAIN All Customs offices FRANCE All customs offices CROATIA All customs offices ITALY All customs offices CYPRUS District Customs House of Nicosia Nicosia District Customs House of Larnaca Larnaca District Customs House of Limassol Limassol LATVIA All customs offices LITHUANIA All customs offices LUXEMBOURG Luxembourg Aéroport (LU715000) Bettembourg (LU701000) HUNGARY Nemzeti Adó- és Vámhivatal megyei (fővárosi) adó-és vámigazgatóságai [all County Directorates and Budapest Capital Directorate of National Tax and Customs Authority] Nemzeti Adó- és Vámhivatal Kiemelt Adó- és Vámigazgatóság [Directorate of Priority Taxpayers of National Tax and Customs Authority] Nemzeti Adó- és Vámhivatal Repülőtéri Igazgatóság [Budapest Airport Directorate of National Tax and Customs Authority] MALTA Export Supervision Unit Lascaris Wharf, Valletta VLT 1920 NETHERLANDS All customs offices AUSTRIA All customs offices POLAND All customs offices PORTUGAL Alfândega Marítima de Lisboa Alfândega do Aeroporto de Lisboa Alfândega de Alverca Alfândega de Leixões Alfândega do Aeroporto de Sá Carneiro (Porto) Alfândega do Funchal Alfândega de Ponta Delgada ROMANIA All customs offices SLOVENIA All customs offices SLOVAK REPUBLIC All customs offices FINLAND All customs offices SWEDEN All customs offices

(1) OJ L 39, 10.2.2009, p. 1.
Notice of the impending expiry of certain anti-dumping measures

(2021/C 226/03)

1. As provided for in Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1), the Commission gives notice that, unless a review is initiated in accordance with the following procedure, the anti-dumping measures mentioned below will expire on the date mentioned in the table below.

2. Procedure

Union producers may submit a written request for a review. This request must contain sufficient evidence that the expiry of the measures would be likely to result in a continuation or recurrence of dumping and injury. Should the Commission decide to review the measures concerned, importers, exporters, representatives of the exporting country and Union producers will then be provided with the opportunity to amplify, rebut or comment on the matters set out in the review request.

3. Time limit

Union producers may submit a written request for a review on the above basis, to reach the European Commission, Directorate-General for Trade (Unit G-1), CHAR 4/39, 1049 Brussels, Belgium (2) at any time from the date of the publication of the present notice but no later than three months before the date mentioned in the table below.

4. This notice is published in accordance with Article 11(2) of Regulation (EU) 2016/1036. Product Country(ies) of origin or exportation Measures Reference Date of expiry (3) Certain graphite electrode systems India Anti-dumping duty Commission Implementing Regulation (EU) 2017/422 of 9 March 2017 imposing a definitive anti-dumping duty on imports of certain graphite electrode systems originating in India following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council (OJ L 64, 10. 3.2017, p. 46) 11.3.2022

(1) OJ L 176, 30.6.2016, p. 21.

(2) TRADE-Defence-Complaints@ec.europa.eu

(3) The measure expires at midnight (00:00) of the day mentioned in this column.