# Official Journal C 76/2021

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 76 |
| | |
| English edition | Information and Notices | Volume 645 March 2021 |

ISSN 1977-091X

Official Journal

of the European Union

C 76

English edition

Information and Notices

Volume 645 March 2021

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| Contents | page |
| --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2021/C 76/01 | Commission Notice – Handling of duplicate marketing authorisation applications of pharmaceutical products under Article 82(1) of Regulation (EC) No 726/2004 | 1 |

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2021/C 76/01

Commission Notice – Handling of duplicate marketing authorisation applications of pharmaceutical products under Article 82(1) of Regulation (EC) No 726/2004

1

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| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | Council |
| 2021/C 76/02 | Notice for the attention of the persons subject to the restrictive measures provided for in Council Decision 2014/119/CFSP, as amended by Council Decision (CFSP) 2021/394, and in Council Regulation (EU) No 208/2014 as implemented by Council Implementing Regulation (EU) 2021/391 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Ukraine | 11 |
| 2021/C 76/03 | Notice for the attention of the data subjects to whom the restrictive measures provided for in Council Decision 2014/119/CFSP and Council Regulation (EU) No 208/2014 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Ukraine apply | 13 |
| | European Commission |
| 2021/C 76/04 | Euro exchange rates — 4 March 2021 | 15 |
| | NOTICES FROM MEMBER STATES |
| 2021/C 76/05 | Commission notice pursuant to Article 17(5) 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 – Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations (
  1
  ) | 16 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

Council

2021/C 76/02

Notice for the attention of the persons subject to the restrictive measures provided for in Council Decision 2014/119/CFSP, as amended by Council Decision (CFSP) 2021/394, and in Council Regulation (EU) No 208/2014 as implemented by Council Implementing Regulation (EU) 2021/391 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Ukraine

11

2021/C 76/03

Notice for the attention of the data subjects to whom the restrictive measures provided for in Council Decision 2014/119/CFSP and Council Regulation (EU) No 208/2014 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Ukraine apply

13

European Commission

2021/C 76/04

Euro exchange rates — 4 March 2021

15

NOTICES FROM MEMBER STATES

2021/C 76/05

Commission notice pursuant to Article 17(5) 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 – Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations (
  1
  )

1

16

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| | V   Announcements |
| --- | --- |
| | ADMINISTRATIVE PROCEDURES |
| | European Investment Bank |
| 2021/C 76/06 | European Investment Bank Institute – Call for proposals – The European Investment Bank Institute proposes a new EIBURS sponsorship under its Knowledge Programme | 17 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2021/C 76/07 | Prior notification of a concentration (Case M.9926 — ADI/Maxim) (
  1
  ) | 21 |
| | OTHER ACTS |
| | European Commission |
| 2021/C 76/08 | Publication of the amended single document following the approval of a minor amendment pursuant to the second subparagraph of Article 53(2) of Regulation (EU) No 1151/2012 | 23 |

V   Announcements

ADMINISTRATIVE PROCEDURES

European Investment Bank

2021/C 76/06

European Investment Bank Institute – Call for proposals – The European Investment Bank Institute proposes a new EIBURS sponsorship under its Knowledge Programme

17

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2021/C 76/07

Prior notification of a concentration (Case M.9926 — ADI/Maxim) (
  1
  )

1

21

OTHER ACTS

European Commission

2021/C 76/08

Publication of the amended single document following the approval of a minor amendment pursuant to the second subparagraph of Article 53(2) of Regulation (EU) No 1151/2012

23

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| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| EN | |
| --- | --- |

EN

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II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 5.3.2021 | EN | Official Journal of the European Union | C 76/1 |
| --- | --- | --- | --- |

5.3.2021

EN

Official Journal of the European Union

C 76/1

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Commission Notice

Handling of duplicate marketing authorisation applications of pharmaceutical products under Article 82(1) of Regulation (EC) No 726/2004

(2021/C 76/01)

Foreword

Requests for duplicate marketing authorisations under Article 82(1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) have increased steadily, and this trend is likely to continue as the use of the centralised procedure rises.

To ensure a smooth application of Article 82(1) and to create more transparency and predictability for the stakeholders concerned, the Commission published a document in March 2010 (updated in 2011 (2)) on the criteria it would use when assessing a request for an application for a duplicate marketing authorisation. The Commission will continue to update this document to address new questions of interpretation of Article 82(1). Section III of the Annex lists the dates and content of the updates that have been made so far.

This notice aims to provide guidance to those who wish to submit a request for an application for a duplicate marketing authorisation. While guidance documents are not legally binding, this Notice is based on the Commission’s interpretation of Article 82(1) of Regulation (EC) No 726/2004. In case of doubt, reference should be made to the appropriate EU directives and regulations. In addition, only the European Court of Justice can give an authentic interpretation of the EU law.

1.   General considerations

A marketing authorisation granted under Regulation (EC) No 726/2004 allows the holder to market the medicinal product in the entire EU. In light of the unique nature and EU dimension of marketing authorisations granted under the centralised procedure, Regulation (EC) No 726/2004 requires that a single name is used to identify a medicinal product authorised under the centralised procedure (3). The Regulation also limits the ability of applicants/holders to obtain more than one marketing authorisation per medicinal product (‘duplicate marketing authorisations’). In particular, Article 82(1) of Regulation (EC) No 726/2004 provides that:

‘Only one authorisation may be granted to an applicant for a specific medicinal product.

However, the Commission shall authorise the same applicant to submit more than one application to the Agency for that medicinal product when there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients, or for co-marketing reasons.’

The assessment of whether the conditions of Article 82(1) have been met must be done on a case-by-case basis, looking at the facts of each application. Nevertheless, prospective applicants should note that the second subparagraph of Article 82(1) is an exception to the general rule set out in the first subparagraph and should be therefore subject to restrictive interpretation. The overall objectives of preserving public health and the harmonisation of centrally authorised products must also play an important role.

2.   Marketing authorisation applications under the scope of Article 82(1)

Marketing authorisation applications under the scope of Article 82(1)

Article 82(1) of Regulation (EC) No 726/2004 concerns marketing authorisation applications submitted by an applicant for a medicinal product for which they have already been granted a marketing authorisation under the centralised procedure.

Note that a marketing authorisation for a medicinal product that differs from a previously authorised product is not considered a duplicate and therefore does not need to be assessed under Article 82(1). This also means that any such application cannot benefit from any fee reduction that applies to duplicates.

By contrast, a marketing authorisation application for a medicinal product that has already been granted a marketing authorisation under the centralised procedure does fall under Article 82(1) if the applicant is the same (4) as the one that holds the original marketing authorisation. Such an application could qualify for a fee reduction that may be applicable for duplicates but, in turn, could only be granted if the conditions under Article 82(1) are met.

4

When assessing whether an application concerns a specific medicinal product that has already been granted a marketing authorisation, and therefore falls under the scope of Article 82(1), the Commission will consider the composition in active substance(s) and the pharmaceutical form. This is in line with the ‘Communication on the Community marketing authorisation procedures for medicinal products’ (5), which states that any medicinal product with the same qualitative and quantitative composition in active substance (i.e. the same strength) and the same pharmaceutical form is to be considered as the same product.

5

In addition, Article 10(2)(b) of Directive 2001/83/EC of the European Parliament and of the Council (6) states that ‘the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy’. While Article 10 deals with the assessment of generic applications, it is appropriate to apply the same principle when assessing differences under Article 82(1).

6

When a separate marketing authorisation application is required by law, it falls outside the scope of Article 82(1), meaning that the applicant does not have to submit a request for a duplicate marketing authorisation to the Commission.

Sections 2.1 and 2.2 below set out practical cases that fall outside and inside the scope of Article 82(1) respectively.

2.1.   Applications outside the scope of Article 82(1)

Applications outside the scope of Article 82(1)

Applications that fall outside the scope of Article 82(1) include the following cases:

| — | The active substance(s) is not the same. |
| --- | --- |

—

The active substance(s) is not the same.

| — | The active substance is a different salt, ester, ether, isomer, mixture of isomers, complex or derivative that differs significantly in properties regarding safety or efficacy. |
| --- | --- |

—

The active substance is a different salt, ester, ether, isomer, mixture of isomers, complex or derivative that differs significantly in properties regarding safety or efficacy.

| — | The medicinal product contains different excipients that result in significant differences in safety or efficacy. |
| --- | --- |

—

The medicinal product contains different excipients that result in significant differences in safety or efficacy.

| — | The manufacturer or manufacturing site is different and may, as a result of the characteristics of the product (notably in the case of biological products), lead to significant differences in safety or efficacy. |
| --- | --- |

—

The manufacturer or manufacturing site is different and may, as a result of the characteristics of the product (notably in the case of biological products), lead to significant differences in safety or efficacy.

| — | Applications submitted under Article 7(3) of Regulation (EC) No 141/2000: that provision provides that an orphan and non-orphan indication cannot be covered by the same marketing authorisation. |
| --- | --- |

—

Applications submitted under Article 7(3) of Regulation (EC) No 141/2000: that provision provides that an orphan and non-orphan indication cannot be covered by the same marketing authorisation.

| — | Applications submitted under Article 30 of Regulation (EC) No 1901/2006 or applications for marketing authorisations for other indications where the initial marketing authorisation has been submitted under Article 30 of Regulation (EC) No 1901/2006. Article 30 provides for a new, self-standing type of marketing authorisation called the Paediatric Use Marketing Authorisation. |
| --- | --- |

—

Applications submitted under Article 30 of Regulation (EC) No 1901/2006 or applications for marketing authorisations for other indications where the initial marketing authorisation has been submitted under Article 30 of Regulation (EC) No 1901/2006. Article 30 provides for a new, self-standing type of marketing authorisation called the Paediatric Use Marketing Authorisation.

2.2.   Applications under the scope of Article 82(1)

Applications under the scope of Article 82(1)

Applications that fall under the scope of Article 82(1) include the following cases:

| — | The active substance is a different salt, ester, ether, isomer, mixture of isomers, complex or derivative that does not differ significantly in properties regarding safety or efficacy. |
| --- | --- |

—

The active substance is a different salt, ester, ether, isomer, mixture of isomers, complex or derivative that does not differ significantly in properties regarding safety or efficacy.

| — | The medicinal product contains different excipients that do not result in significant differences in safety or efficacy. |
| --- | --- |

—

The medicinal product contains different excipients that do not result in significant differences in safety or efficacy.

| — | Different manufacturer or manufacturing site, unless this leads to significant differences in safety or efficacy. |
| --- | --- |

—

Different manufacturer or manufacturing site, unless this leads to significant differences in safety or efficacy.

| — | Differences in the data submitted in connection with the marketing authorisation application for a medicinal product with the same composition in active substance(s) and pharmaceutical form (e.g. data to show bioequivalence), provided that the product does not significantly differ in terms of safety or efficacy. |
| --- | --- |

—

Differences in the data submitted in connection with the marketing authorisation application for a medicinal product with the same composition in active substance(s) and pharmaceutical form (e.g. data to show bioequivalence), provided that the product does not significantly differ in terms of safety or efficacy.

| — | In addition, the fact that one marketing authorisation application is submitted in accordance with Article 8(3) of Directive 2001/83/EC and the other marketing authorisation application is submitted under an abridged procedure (e.g. generic, biosimilar or hybrid application, informed consent) (7) is irrelevant provided that both applications relate to a medicinal product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form. |
| --- | --- |

—

In addition, the fact that one marketing authorisation application is submitted in accordance with Article 8(3) of Directive 2001/83/EC and the other marketing authorisation application is submitted under an abridged procedure (e.g. generic, biosimilar or hybrid application, informed consent) (7) is irrelevant provided that both applications relate to a medicinal product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form.

7

| — | A duplicate application may contain fewer indications or pharmaceutical forms than the original application/marketing authorisation when this is necessary to market the product in Member States where a specific indication or pharmaceutical form is protected by patent law. |
| --- | --- |

—

A duplicate application may contain fewer indications or pharmaceutical forms than the original application/marketing authorisation when this is necessary to market the product in Member States where a specific indication or pharmaceutical form is protected by patent law.

However, in order to maintain the harmonisation of the Summary of Product Characteristics (SmPCs), the applicant should provide a commitment letter undertaking to extend the indication(s)/pharmaceutical form(s) of the duplicate marketing authorisation when the patent restrictions no longer exist. Alternatively, the applicant may also commit to withdrawing the marketing authorisation with restricted indications/pharmaceutical forms after the relevant patents are no longer in force. Given that the harmonisation of SmPCs across the EU is one of the basic pillars of the centralised procedure, applicants of duplicate marketing authorisations should not market the two products with different indications/ strengths/ pharmaceutical forms in the same country. The commitment letter should accompany the marketing authorisation application dossier.

The Commission considers it necessary to emphasize that applications falling under the scope of Article 82(1) can only lead to the granting of a marketing authorisation if the conditions set out in that Article are met. Prospective applicants are therefore advised to inform the European Medicines Agency (the Agency) when an application falls under Article 82(1) and to seek advice in case of doubt (e.g. if a different manufacturing site is used for a biological medicinal product).

For the sake of clarity, the extent of the scientific assessment required from the Agency and any possible consequences in terms of fees fall outside the scope of this document.

3.   Validation of duplicate marketing authorisation applications by the Agency

Validation of duplicate marketing authorisation applications by the Agency

Applications for marketing authorisations, including duplicates, are submitted to the Agency. For the validation of a duplicate marketing authorisation, the Agency checks:

| — | That the duplicate application is submitted by the same applicant that has submitted the marketing authorisation/application that is being duplicated (the ‘original marketing authorisation/application’). See Section 5.1 for further clarifications. |
| --- | --- |

—

That the duplicate application is submitted by the same applicant that has submitted the marketing authorisation/application that is being duplicated (the ‘original marketing authorisation/application’). See Section 5.1 for further clarifications.

| — | That the original marketing authorisation is valid. See Section 5.2 for further clarifications. This step does not apply to duplicate applications that are submitted in parallel with the original marketing authorisation application (i.e. in cases where the application for the original marketing authorisation is still pending). |
| --- | --- |

—

That the original marketing authorisation is valid. See Section 5.2 for further clarifications. This step does not apply to duplicate applications that are submitted in parallel with the original marketing authorisation application (i.e. in cases where the application for the original marketing authorisation is still pending).

| — | In cases where the duplicate marketing authorisation is submitted on the basis of an informed consent application, that there is a letter of consent from the marketing authorisation holder that owns the dossier that is referred to, as is the case for applications submitted under Article 10c of Directive 2001/83/EC. See Section 5.3 for further clarifications. |
| --- | --- |

—

In cases where the duplicate marketing authorisation is submitted on the basis of an informed consent application, that there is a letter of consent from the marketing authorisation holder that owns the dossier that is referred to, as is the case for applications submitted under Article 10c of Directive 2001/83/EC. See Section 5.3 for further clarifications.

| — | That an authorisation by the Commission to submit a duplicate marketing authorisation application has been granted. See Section 5.3 for further clarifications. |
| --- | --- |

—

That an authorisation by the Commission to submit a duplicate marketing authorisation application has been granted. See Section 5.3 for further clarifications.

4.   The Commission’s authorisation to submit a duplicate marketing authorisation

The Commission’s authorisation to submit a duplicate marketing authorisation

Before granting an authorisation to submit a duplicate marketing authorisation application under Article 82(1), the Commission must be satisfied that the relevant conditions are met. It must therefore verify that:

| — | the applicant is the ‘same applicant’ as explained in Section 5.1; and |
| --- | --- |

—

the applicant is the ‘same applicant’ as explained in Section 5.1; and

| — | the public health reasons or co-marketing reasons are met (see criteria laid down in the Annex to this Notice). |
| --- | --- |

—

the public health reasons or co-marketing reasons are met (see criteria laid down in the Annex to this Notice).

The letter of authorisation should specify:

| — | the name of the marketing authorisation holder relevant for the duplicate application; |
| --- | --- |

—

the name of the marketing authorisation holder relevant for the duplicate application;

| — | the name of the medicinal product for the duplicate application (8); |
| --- | --- |

—

the name of the medicinal product for the duplicate application (8);

8

| — | if co-marketing reasons are being invoked, the evidence of such co-marketing (contract or letter of agreement between the companies) should be provided to the Commission at least 1 month prior to the Committee for Medicinal Products for Human Use (CHMP) issuing its opinion on the duplicate marketing authorisation application; and |
| --- | --- |

—

if co-marketing reasons are being invoked, the evidence of such co-marketing (contract or letter of agreement between the companies) should be provided to the Commission at least 1 month prior to the Committee for Medicinal Products for Human Use (CHMP) issuing its opinion on the duplicate marketing authorisation application; and

| — | if duplicates are requested on grounds of the existence of patents protecting certain therapeutic indications or pharmaceutical forms, the applicant should provide a commitment letter undertaking to extend the therapeutic indication(s)/pharmaceutical form(s) of the duplicate marketing authorisation as soon as the patent restrictions no longer exist. Alternatively, the applicant can commit to withdrawing the marketing authorisation with restricted indications/pharmaceutical forms after the relevant patents are no longer in force. Given that the harmonisation of SmPCs across the EU is one of the basic pillars of the centralised procedure, applicants of duplicate marketing authorisations should not market the two products with different indications/strengths/pharmaceutical forms in the same country. The commitment letter should accompany the marketing authorisation application dossier. |
| --- | --- |

—

if duplicates are requested on grounds of the existence of patents protecting certain therapeutic indications or pharmaceutical forms, the applicant should provide a commitment letter undertaking to extend the therapeutic indication(s)/pharmaceutical form(s) of the duplicate marketing authorisation as soon as the patent restrictions no longer exist. Alternatively, the applicant can commit to withdrawing the marketing authorisation with restricted indications/pharmaceutical forms after the relevant patents are no longer in force. Given that the harmonisation of SmPCs across the EU is one of the basic pillars of the centralised procedure, applicants of duplicate marketing authorisations should not market the two products with different indications/strengths/pharmaceutical forms in the same country. The commitment letter should accompany the marketing authorisation application dossier.

5.   Requirements to be checked for all duplicate marketing authorisation applications

Requirements to be checked for all duplicate marketing authorisation applications

5.1.   ‘Same applicant’

‘Same applicant’

When the Agency receives an application for a marketing authorisation, it should verify if the applicant has already applied for or been granted a marketing authorisation for that product. If so, the Agency will process their application as a duplicate application in line with Article 82(1). Before issuing an authorisation letter under Article 82(1), the Commission should also verify that the applicant for the duplicate marketing authorisation is the same applicant that applied for or holds the original marketing authorisation. In either case, the applicant may be asked to provide the appropriate evidence.

Assessment of requests for authorisation under Article 82(1) should use the same criteria as:

| — | the ‘1998 Communication on the Community marketing authorisation procedures for medicinal products’ to define ‘same entity’; and |
| --- | --- |

—

the ‘1998 Communication on the Community marketing authorisation procedures for medicinal products’ to define ‘same entity’; and

| — | Chapter 2 of the Notice to Applicants to define ‘same applicant’. |
| --- | --- |

—

Chapter 2 of the Notice to Applicants to define ‘same applicant’.

Specifically, this means that a company that belongs to the same group of companies, or companies that have entered into a license agreement or have otherwise agreed with the applicant of the original marketing authorisation as regards the marketing of the relevant medicinal product can apply for a duplicate.

| Scenario | Under the scope of Article 82(1)? |
| --- | --- |
| Applicant is the same that applied for the original marketing authorisation. | yes |
| Applicant belongs to the same group of companies as the applicant of the original marketing authorisation. | yes (9) |
| Applicant is an independent company that has agreed with the applicant of the original marketing authorisation (license agreement or other agreement that can be identified) to place the product on the market. | yes |
| Applicant is an independent company. It has licence agreements with the marketing authorisation holder of the product for which the duplicate is asked but not to place that product on the market (e.g. company A and B have an agreement to place products x1 and x2 on the market, but the requested duplicate is for product x3). | no (10) |
| Applicant is an independent company that has an agreement to purchase and/or use the data of the company that has applied for a marketing authorisation for the product for the first time. However, there is no agreement to place the product on the market. | no (10) |

Scenario

Under the scope of Article 82(1)?

Applicant is the same that applied for the original marketing authorisation.

yes

Applicant belongs to the same group of companies as the applicant of the original marketing authorisation.

yes (9)

9

Applicant is an independent company that has agreed with the applicant of the original marketing authorisation (license agreement or other agreement that can be identified) to place the product on the market.

yes

Applicant is an independent company. It has licence agreements with the marketing authorisation holder of the product for which the duplicate is asked but not to place that product on the market (e.g. company A and B have an agreement to place products x1 and x2 on the market, but the requested duplicate is for product x3).

no (10)

10

Applicant is an independent company that has an agreement to purchase and/or use the data of the company that has applied for a marketing authorisation for the product for the first time. However, there is no agreement to place the product on the market.

no (10)

10

5.2.   Original marketing authorisation is valid

Original marketing authorisation is valid

The duplicate application must relate to an original marketing authorisation that is still valid. It is not possible to submit a duplicate application for a marketing authorisation: (i) that has not been renewed; (ii) that has been withdrawn/revoked or suspended; or (iii) that has ceased to be valid according to Article 24(5) of Directive 2001/83/EC. The Agency may ask the applicant to provide evidence that the original marketing authorisation is valid.

5.3.   Letter of consent in the case of an ‘informed consent application’

Letter of consent in the case of an ‘informed consent application’

A duplicate application requested in the form of an informed consent application in accordance with Article 10c of Directive 2001/83/EC must be accompanied by a letter of consent from the marketing authorisation holder that owns the dossier that is referred to, as it is the case for every application submitted under Article 10c.

5.4.   Authorisation by the Commission to submit a duplicate marketing authorisation

Authorisation by the Commission to submit a duplicate marketing authorisation

Companies requesting a duplicate marketing authorisation can initiate pre-submission activities with the Agency prior to having the Commission’s agreement as required under Article 82(1). They should note, however, that the duplicate marketing authorisation cannot be granted if the Commission has not issued an authorisation letter prior to the CHMP opinion, or if any requirements stated therein have not been complied with prior to the CHMP opinion.

It is therefore extremely important that applicants apply for an authorisation letter and provide any relevant information that may be requested promptly and at least 1 month prior to the CHMP opinion.

Applicants should also complete the information template provided in Section II of the Annex to this Notice and submit it with their request letter. The template should be used for all applications submitted from 1 April 2021 onwards.

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(1)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

1

(2)  https://ec.europa.eu/health/sites/health/files/files/latest_news/2011_09_duplicates_note_upd_01.pdf

2

(3)  Article 6(1) of Regulation (EC) No 726/2004.

3

(4)  Cf. Section 5.1 below.

4

(5)  OJ C 229, 22.7.1998, p. 4. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/com_1998/com_1998_en.pdf

5

(6)  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).

6

(7)  Articles 10 and 10(c) of Directive 2001/83/EC refer to different types of abridged procedures, where a company may refer to data included in other marketing authorisation dossiers.

7

(8)  If the proposed name is not accepted by the Agency’s Name Review Group, the letter of authorisation may be updated as appropriate.

8

(9)  Unless the request for the duplicate marketing authorisation is on grounds of co-marketing (see Annex, section I B).

9

(10)  This application is to be treated in accordance with Article 6 of Regulation (EC) No 726/2004.

10

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ANNEX

SECTION I

Commission assessment of public health and co-marketing reasons

A.   Public health reasons

Under Article 82(1) of Regulation (EC) No 726/2004, the Commission can grant a duplicate marketing authorisation if there are objective, verifiable reasons relating to public health that show an increased availability of medicinal products to healthcare professionals and/or patients.

Having more than one authorisation does not necessarily increase the availability of a particular product, as this would devoid of purpose the principle in Article 82(1) which provides that only one single marketing authorisation should be granted per product to the same applicant/holder. Therefore, any claim that a duplicate marketing authorisation would increase a product’s availability should be assessed on a case-by-case basis by examining the justification and evidence provided by the applicant.

The most common case in which a duplicate is justified on public health grounds is when there is an indication or pharmaceutical form in the Summary of Product Characteristics (SmPCs) of the original application/marketing authorisation that is protected by patent law in one or more Member States. In this context, Article 11 of Directive 2001/83/EC specifically allows for the submission of different SmPCs on grounds related to patent law. While this article refers to generic applications, the same considerations (i.e. the need to ensure availability of the product in the Member States where there is patent protection) can also apply to duplicate applications.

In such cases and in order to maintain the harmonisation of the SmPCs the applicant should provide a commitment letter undertaking to extend the indication/pharmaceutical form of the duplicate marketing authorisation, as soon as the patent restrictions no longer exist. Alternatively, the applicant may commit to withdrawing the duplicate marketing authorisation with restricted indications/pharmaceutical forms after the relevant patents are no longer in force. Given that the harmonisation of SmPCs across the EU is one of the basic pillars of the centralised procedure, applicants of duplicate marketing authorisations should not be allowed to market two products with different indications/pharmaceutical forms in the same country.

The commitment letter should accompany the marketing authorisation application dossier.

For any other case, the applicant should demonstrate how the duplicate marketing authorisation increases availability and patient access, based on objective and verifiable evidence, including but not limited to the following information:

| i) | the Member States where the original medicinal product is actually marketed; |
| --- | --- |

i)

the Member States where the original medicinal product is actually marketed;

| ii) | the Member States where the duplicate medicinal product is intended to be marketed; |
| --- | --- |

ii)

the Member States where the duplicate medicinal product is intended to be marketed;

| iii) | the Member States in which the duplicate is not to be placed on the market: the applicant should explain the reasons for not marketing the product in these countries. |
| --- | --- |

iii)

the Member States in which the duplicate is not to be placed on the market: the applicant should explain the reasons for not marketing the product in these countries.

In the past, the Commission has granted duplicate marketing authorisations to the holder of the marketing authorisation of the original medicinal product in order to increase availability. However, experience shows (1) that there is no automatic link between the introduction of a duplicate marketing authorisation by the holder of the original medicinal product (be it a chemical or a biological medicinal product) and increased availability. Taking into account that a duplicate marketing authorisation can only be granted exceptionally, the applicant should provide the Commission with specific evidence that demonstrates that the duplicate marketing authorisation is likely to increase availability.

| Scenario | In compliance with Article 82(1)? |
| --- | --- |
| Patents on indications or pharmaceutical forms | yes |
| Pricing and reimbursement considerations | no |
| Classification (prescription/non-prescription) considerations | no |
| Considerations based on national legislation deemed incompatible with EU law (e.g. names) | no |

Scenario

In compliance with Article 82(1)?

Patents on indications or pharmaceutical forms

yes

Pricing and reimbursement considerations

no

Classification (prescription/non-prescription) considerations

no

Considerations based on national legislation deemed incompatible with EU law (e.g. names)

no

B.   Co-marketing reasons

Under Article 82(1), the Commission can grant a duplicate marketing authorisation for co-marketing reasons when the marketing authorisation holder can prove that he will stipulate a co-marketing agreement with one or more companies for the product for which the duplicate is requested. A co-marketing arrangement is generally understood as an agreement between two parties to commercialise a specific medical product under different trademarks.

Note that co-marketing requires the existence of two parties, i.e. a request for authorisation under Article 82(1) on co-marketing grounds will not be accepted when the two marketing entities belong to the same company group. Likewise, an application for a duplicate cannot be accepted if the co-marketing partners are already co-marketing (together) the product in the EU (i.e. product A is co-marketed by company X and Y and company Y applies for a duplicate marketing authorisation of product A on grounds of co-marketing with company X).

Co-marketing can be limited to one or more Member States or cover the entire EU. It must however, not lead to partition of the internal market.

To grant a duplicate marketing authorisation for co-marketing reasons, it is necessary that the evidence of such co-marketing (contract or letter of agreement between the companies) is provided to the Commission at least 1 month before the CHMP issues its opinion.

| Scenario | In compliance with Article 82(1)? |
| --- | --- |
| Co-marketing with a company of the same group? | no |
| Co-marketing with another independent company? | yes |
| Data required | Name of the co-marketing partner and proof that the envisaged co-marketing for that product will actually take place (e.g. contract or letter of agreement between the companies).
  The required evidence must have been received at least 1 month prior to the adoption of an opinion by the CHMP. |

Scenario

In compliance with Article 82(1)?

Co-marketing with a company of the same group?

no

Co-marketing with another independent company?

yes

Data required

Name of the co-marketing partner and proof that the envisaged co-marketing for that product will actually take place (e.g. contract or letter of agreement between the companies).

The required evidence must have been received at least 1 month prior to the adoption of an opinion by the CHMP.

SECTION II

Template

Information an applicant must provide to the European Commission for a request to submit a duplicate marketing authorisation under Article 82(1) of Regulation (EC) No 726/2004

| Name of the marketing authorisation holder (2) relevant for the duplicate marketing authorisation application | |
| --- | --- |
| Name of the original product for which the duplicate is requested | |
| Name(s) - or name(s) proposed to the Name Review Group - of the product(s) relevant for the duplicate marketing authorisation application | |
| Grounds of the request (public health reasons related to the availability of the medicinal product or co-marketing reasons) | |

Name of the marketing authorisation holder (2) relevant for the duplicate marketing authorisation application

Name of the original product for which the duplicate is requested

Name(s) - or name(s) proposed to the Name Review Group - of the product(s) relevant for the duplicate marketing authorisation application

Grounds of the request (public health reasons related to the availability of the medicinal product or co-marketing reasons)

| In case of co-marketing, the name of the co-marketer | |
| --- | --- |
| In case of co-marketing, the proof that the envisaged co-marketing for that product will actually take place (e.g. contract or letter of agreement between the companies) | |
| In case of public health reasons related to intellectual property that impact indications or pharmaceutical forms in the SmPC of the original application/marketing authorisation:






  — | the number and name(s) of indication(s)/pharmaceutical forms claimed for each duplicate marketing authorisation product(s) relevant for the application |

In case of co-marketing, the name of the co-marketer

In case of co-marketing, the proof that the envisaged co-marketing for that product will actually take place (e.g. contract or letter of agreement between the companies)

In case of public health reasons related to intellectual property that impact indications or pharmaceutical forms in the SmPC of the original application/marketing authorisation:

—

the number and name(s) of indication(s)/pharmaceutical forms claimed for each duplicate marketing authorisation product(s) relevant for the application

| — | the list of Member States where the duplicate is intended to be marketed, clarifying the patent situation (in force or not in force) and the patent expiry date by Member State for each patented indication/pharmaceutical form. This information should be provided in a table: |
| --- | --- |

—

the list of Member States where the duplicate is intended to be marketed, clarifying the patent situation (in force or not in force) and the patent expiry date by Member State for each patented indication/pharmaceutical form. This information should be provided in a table:

Member State

Patent situation

Patent expiry date

| — | a commitment letter undertaking to






  ✓ | extend the therapeutic indication(s)/pharmaceutical form(s) of the duplicate marketing authorisation as soon as the patent restrictions no longer exist, OR |
| --- | --- | --- |

—

a commitment letter undertaking to

✓

extend the therapeutic indication(s)/pharmaceutical form(s) of the duplicate marketing authorisation as soon as the patent restrictions no longer exist, OR

| ✓ | withdraw the marketing authorisation with restricted indication(s)/pharmaceutical form(s) after the relevant patent is no longer in force |
| --- | --- |

✓

withdraw the marketing authorisation with restricted indication(s)/pharmaceutical form(s) after the relevant patent is no longer in force

| — | a commitment letter stating that the applicant will not market two products with different indications/strengths/pharmaceutical forms in the same country |
| --- | --- |

—

a commitment letter stating that the applicant will not market two products with different indications/strengths/pharmaceutical forms in the same country

In case of public health reasons not related to intellectual property, the specific evidence demonstrating that the duplicate marketing authorisation are likely to increase availability, including but not limited to the following information:

| — | the list of Member States where the ‘first’ medicinal product is actually marketed, AND |
| --- | --- |

—

the list of Member States where the ‘first’ medicinal product is actually marketed, AND

| — | the list of Member States where the duplicate medical product is intended to be marketed, AND |
| --- | --- |

—

the list of Member States where the duplicate medical product is intended to be marketed, AND

| — | the list of Member States in which the duplicate is not to be placed on the market and the reasons for not marketing the product in these countries. |
| --- | --- |

—

the list of Member States in which the duplicate is not to be placed on the market and the reasons for not marketing the product in these countries.

SECTION III

History of the document

| Version | Main changes | Date |
| --- | --- | --- |
| First Communication | | March 2010 |
| Update 1 | — | Addition of the ‘General Considerations’ section. |

Version

Main changes

Date

First Communication

March 2010

Update 1

—

Addition of the ‘General Considerations’ section.

| — | Addition of a section regarding the Clarification of the scope of Article 82(1). |
| --- | --- |

—

Addition of a section regarding the Clarification of the scope of Article 82(1).

| — | Clarification of the ‘public health reasons’ relevant for authorising the submission of a duplicate application. |
| --- | --- |

—

Clarification of the ‘public health reasons’ relevant for authorising the submission of a duplicate application.

October 2011

Update 2 (Current version)

| — | Clarification of the scope of Article 82(1). |
| --- | --- |

—

Clarification of the scope of Article 82(1).

| — | Clarification of the ‘public health reasons’ relevant for authorising the submission of a duplicate application. |
| --- | --- |

—

Clarification of the ‘public health reasons’ relevant for authorising the submission of a duplicate application.

| — | New Annex ‘Template: Information an applicant must provide to the European Commission for a request to submit a duplicate marketing authorisation under Article 82(1) of Regulation (EC) No 726/2004’. |
| --- | --- |

—

New Annex ‘Template: Information an applicant must provide to the European Commission for a request to submit a duplicate marketing authorisation under Article 82(1) of Regulation (EC) No 726/2004’.

February 2021

---

(1)  Targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products, https://ec.europa.eu/health/human-use/consultations/20180518_biologicalmedicinalproducts_en

(2)  If the applicant requesting the duplicate is not the same as the one that applied for the original marketing authorisation, but belongs to the same group of companies, please clarify it here.

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

Council

| 5.3.2021 | EN | Official Journal of the European Union | C 76/11 |
| --- | --- | --- | --- |

5.3.2021

EN

Official Journal of the European Union

C 76/11

---

Notice for the attention of the persons subject to the restrictive measures provided for in Council Decision 2014/119/CFSP, as amended by Council Decision (CFSP) 2021/394, and in Council Regulation (EU) No 208/2014 as implemented by Council Implementing Regulation (EU) 2021/391 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Ukraine

(2021/C 76/02)

The following information is brought to the attention of the persons who appear in the Annex to Council Decision 2014/119/CFSP (1), as amended by Council Decision (CFSP) 2021/394 (2), and in Annex I to Council Regulation (EU) No 208/2014 (3) as implemented by Council Implementing Regulation (EU) 2021/391 (4) concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Ukraine.

The Council of the European Union has decided that the persons that appear in the abovementioned Annexes should be included in the list of persons and entities subject to restrictive measures provided for in Decision 2014/119/CFSP and in Regulation (EU) No 208/2014 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Ukraine. The grounds for designations of those persons appear in the relevant entries in those Annexes.

The attention of the persons concerned is drawn to the possibility of making an application to the competent authorities of the relevant Member State(s) as indicated in the websites in Annex II to Regulation (EU) No 208/2014, in order to obtain an authorisation to use frozen funds for basic needs or specific payments (cf. Article 4 of the Regulation).

The persons concerned may submit a request to the Council, together with supporting documentation, that the decision to include them on the abovementioned list should be reconsidered, before 10 December 2021 to the following address:

| Council of the European Union |
| --- |
| General Secretariat |
| RELEX.1.C |
| Rue de la Loi/Wetstraat 175 |
| 1048 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

Council of the European Union

General Secretariat

RELEX.1.C

Rue de la Loi/Wetstraat 175

1048 Bruxelles/Brussel

BELGIQUE/BELGIË

Email: sanctions@consilium.europa.eu

The attention of the persons concerned is also drawn to the possibility of challenging the Council’s decision before the General Court of the European Union, in accordance with the conditions laid down in Article 275, second paragraph, and Article 263, fourth and sixth paragraphs, of the Treaty on the Functioning of the European Union.

---

(1)  OJ L 66, 6.3.2014, p. 26.

(2)  OJ L 77, 5.3.2021, p. 29

(3)  OJ L 66, 6.3.2014, p. 1.

(4)  OJ L 77, 5.3.2021, p. 2

---

| 5.3.2021 | EN | Official Journal of the European Union | C 76/13 |
| --- | --- | --- | --- |

5.3.2021

EN

Official Journal of the European Union

C 76/13

---

Notice for the attention of the data subjects to whom the restrictive measures provided for in Council Decision 2014/119/CFSP and Council Regulation (EU) No 208/2014 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Ukraine apply

(2021/C 76/03)

The attention of data subjects is drawn to the following information in accordance with Article 16 of Regulation (EU) 2018/1725 of the European Parliament and of the Council (1).

The legal basis for this processing operation are Council Decision 2014/119/CFSP (2), as amended by Council Decision (CFSP) 2021/394 (3), and Council Regulation (EU) No 208/2014 (4) as implemented by Council Implementing Regulation (EU) 2021/391 (5).

The controller of this processing operation is the Department RELEX.1.C in the Directorate-General for External Relations – RELEX of the General Secretariat of the Council (GSC), that can be contacted at:

| Council of the European Union |
| --- |
| General Secretariat |
| RELEX.1.C |
| Rue de la Loi/Wetstraat 175 |
| 1048 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

Council of the European Union

General Secretariat

RELEX.1.C

Rue de la Loi/Wetstraat 175

1048 Bruxelles/Brussel

BELGIQUE/BELGIË

Email: sanctions@consilium.europa.eu

The GSC’s Data Protection Officer can be contacted at:

Data Protection Officer

data.protection@consilium.europa.eu

The purpose of the processing operation is the establishment and updating of the list of persons subject to restrictive measures in accordance with Decision 2014/119/CFSP, as amended by Decision (CFSP) 2021/394, and Regulation (EU) No 208/2014 as implemented by Implementing Regulation (EU) 2021/391.

The data subjects are the natural persons who fulfil the listing criteria as laid down in Decision 2014/119/CFSP and Regulation (EU) No 208/2014.

The personal data collected includes data necessary for the correct identification of the person concerned, the statement of reasons and any other data related thereto.

The personal data collected may be shared as necessary with the European External Action Service and the Commission.

Without prejudice to restrictions pursuant to Article 25 of Regulation (EU) 2018/1725, the exercise of the rights of the data subjects such as the right of access, as well as the rights to rectification or to object will be answered in accordance with Regulation (EU) 2018/1725.

Personal data will be retained for 5 years from the moment the data subject has been removed from the list of persons subject to the restrictive measures or the validity of the measure has expired, or for the duration of court proceedings in the event they had been started.

Without prejudice to any judicial, administrative or non-judicial remedy, data subjects may lodge a complaint with the European Data Protection Supervisor in accordance with Regulation (EU) 2018/1725 (edps@edps.europa.eu).

---

(1)  OJ L 295, 21.11.2018, p. 39.

(2)  OJ L 66, 6.3.2014, p. 26.

(3)  OJ L 77, 5.3.2021, p. 29

(4)  OJ L 66, 6.3.2014, p. 1.

(5)  OJ L 77, 5.3.2021, p. 2.

---

European Commission

| 5.3.2021 | EN | Official Journal of the European Union | C 76/15 |
| --- | --- | --- | --- |

5.3.2021

EN

Official Journal of the European Union

C 76/15

---

Euro exchange rates (1)

4 March 2021

(2021/C 76/04)

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2034 |
| JPY | Japanese yen | 129,23 |
| DKK | Danish krone | 7,4361 |
| GBP | Pound sterling | 0,86270 |
| SEK | Swedish krona | 10,1595 |
| CHF | Swiss franc | 1,1114 |
| ISK | Iceland króna | 153,30 |
| NOK | Norwegian krone | 10,2595 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 26,208 |
| HUF | Hungarian forint | 364,53 |
| PLN | Polish zloty | 4,5529 |
| RON | Romanian leu | 4,8813 |
| TRY | Turkish lira | 8,9666 |
| AUD | Australian dollar | 1,5449 |
| CAD | Canadian dollar | 1,5213 |
| HKD | Hong Kong dollar | 9,3363 |
| NZD | New Zealand dollar | 1,6599 |
| SGD | Singapore dollar | 1,6024 |
| KRW | South Korean won | 1 353,89 |
| ZAR | South African rand | 18,0926 |
| CNY | Chinese yuan renminbi | 7,7846 |
| HRK | Croatian kuna | 7,5870 |
| IDR | Indonesian rupiah | 17 166,50 |
| MYR | Malaysian ringgit | 4,8828 |
| PHP | Philippine peso | 58,399 |
| RUB | Russian rouble | 88,6563 |
| THB | Thai baht | 36,511 |
| BRL | Brazilian real | 6,7469 |
| MXN | Mexican peso | 25,0615 |
| INR | Indian rupee | 87,5520 |

Currency

Exchange rate

USD

US dollar

1,2034

JPY

Japanese yen

129,23

DKK

Danish krone

7,4361

GBP

Pound sterling

0,86270

SEK

Swedish krona

10,1595

CHF

Swiss franc

1,1114

ISK

Iceland króna

153,30

NOK

Norwegian krone

10,2595

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

26,208

HUF

Hungarian forint

364,53

PLN

Polish zloty

4,5529

RON

Romanian leu

4,8813

TRY

Turkish lira

8,9666

AUD

Australian dollar

1,5449

CAD

Canadian dollar

1,5213

HKD

Hong Kong dollar

9,3363

NZD

New Zealand dollar

1,6599

SGD

Singapore dollar

1,6024

KRW

South Korean won

1 353,89

ZAR

South African rand

18,0926

CNY

Chinese yuan renminbi

7,7846

HRK

Croatian kuna

7,5870

IDR

Indonesian rupiah

17 166,50

MYR

Malaysian ringgit

4,8828

PHP

Philippine peso

58,399

RUB

Russian rouble

88,6563

THB

Thai baht

36,511

BRL

Brazilian real

6,7469

MXN

Mexican peso

25,0615

INR

Indian rupee

87,5520

---

(1)  Source: reference exchange rate published by the ECB.

---

NOTICES FROM MEMBER STATES

| 5.3.2021 | EN | Official Journal of the European Union | C 76/16 |
| --- | --- | --- | --- |

5.3.2021

EN

Official Journal of the European Union

C 76/16

---

Commission notice pursuant to Article 17(5) 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

Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations

(Text with EEA relevance)

(2021/C 76/05)

| Member State | Spain |
| --- | --- |
| Concerned route | La Gomera – Tenerife Norte / La Gomera – Gran Canaria |
| Period of validity of the contract | From 1 August 2021 to 31 July 2024 |
| Deadline for submission of tenders | 2 months following the date of publication of this notice |
| Address where the text of the invitation to tender and any relevant information and/or documentation related to the public tender and the public service obligation 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 |

Member State

Spain

Concerned route

La Gomera – Tenerife Norte / La Gomera – Gran Canaria

Period of validity of the contract

From 1 August 2021 to 31 July 2024

Deadline for submission of tenders

2 months following the date of publication of this notice

Address where the text of the invitation to tender and any relevant information and/or documentation related to the public tender and the public service obligation 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

Email: osp.dgac@mitma.es

---

V Announcements

ADMINISTRATIVE PROCEDURES

European Investment Bank

| 5.3.2021 | EN | Official Journal of the European Union | C 76/17 |
| --- | --- | --- | --- |

5.3.2021

EN

Official Journal of the European Union

C 76/17

---

European Investment Bank Institute

Call for proposals

The European Investment Bank Institute proposes a new EIBURS sponsorship under its Knowledge Programme

(2021/C 76/06)

The Knowledge Programme of the European Investment Bank Institute (EIB Institute) channels its research grants through different schemes, one of which is:

EIBURS, the EIB University Research Sponsorship Programme

EIBURS provides grants to university departments or research centres associated with universities in EU, candidate or potential candidate countries working on research topics of major interest to the Bank. EIBURS sponsorships – of up to EUR 100 000 per year for a period of three years – are awarded through a competitive process to interested university departments or research centres with recognised expertise in the selected area. Successful proposals entail the delivery of a variety of outputs that will be the subject of a contractual agreement with the European Investment Bank.

For the academic year 2020/2021, the EIBURS programme is seeking proposals on a new research theme:

‘Impact of gender mainstreaming in infrastructure projects – Evidence from a water project in Madagascar’

1.   Background

The EIB Group Strategy on Gender and Women’s Economic Empowerment (GS) took effect in January 2017. This strategy aims to embed gender equality and women’s economic empowerment into the EIB Group’s activities both inside and outside the European Union. The GS is implemented through the Gender Action Plan (GAP), which provides a roadmap and specifies activities for the EIB Group to undertake to ensure fulfilment of the commitments made under the strategy (2017-2022).

The GAP includes four areas of activity, among which is enhancing the impact of EIB operations on gender equality. To ensure that EIB operations mainstream due attention to gender into the investment process, the EIB Group is introducing a gender tag, akin to a classification system, at the appraisal stage. The purpose of the tag is to readily identify, ex ante, those operations likely to have an impact on gender equality. Such ex ante assessments are particularly important for investments not targeting gender equality as a specific outcome or objective but that could, with the right design features or in the right geographies/sectors, have significant effects on gender equality. For example, evidence seems to indicate that incorporating gender concerns into the design and implementation of infrastructure projects makes project benefits more accessible and inclusive, and enhances projects’ development impact (ADB 2019) (1). Similarly, it is expected that infrastructure investments designed in a gender-responsive manner may increase women’s economic resilience and well-being, for instance through time saving, increased sense of safety and security, increased mobility, higher bargaining power or by overcoming social norms that cause barriers (e.g. digital investments overcome norms that limit women’s mobility and therefore access to banking or information), etc. (2) However, at this pilot stage, progress is required in developing rigorous ex ante estimations to guide project design and measurement approaches in relation to gender equality outcomes and impacts of the EIB-supported infrastructure operations.

The EIB is currently considering using women’s time usage as a proxy indicator of the impact that infrastructure investments can have on freeing up women’s time to engage in productive activities and hence to reduce the gender wage and pension gaps. However, the suitability and effectiveness of using this indicator still has to be tested. The EIB has thus approved a pilot phase during which such an indicator, its use and its validity will be explored alongside its potential practicable application to EIB infrastructure investments. This call for proposals will focus on a water investment project and tackle this issue from this perspective.

2.   Focus of the project

The aim of the present research project is, prior to the implementation of the intervention, to design and initiate an impact evaluation, including the gathering of baseline data, and provide guidance on the best indicator(s) for the EIB to use as a proxy of gender equality impact in water infrastructure projects.

More specifically, we propose focusing the empirical research on a water project in Madagascar that aims to strengthen and improve the drinking water supply in Antananarivo in terms of availability, quality of service and coverage (3). Women in Antananarivo, in particular in peri-urban communities and informal settlements, disproportionately suffer from the lack of access to potable water, as they carry most of the burden of water collection – including time, calories spent, musculoskeletal injuries, and risk of assault or attack. Financing such projects is therefore assumed to contribute to gender equality. However, evidence is mixed, as shown in the 2018 evidence gap map published by 3ie on the topic (4). Although some recent studies evaluate interventions and outcomes that disproportionately affect women and girls, gender analysis is rarely used as part of the framework for understanding gendered programme effects. This is due, in part, to a lack of sex-disaggregated data in the reporting. The overall objective of the impact evaluation is to rigorously assess the overall and gender-differentiated causal impact of the JIRAMA III drinking water project on variables such as time gains, health outcomes (e.g. water-borne illnesses, infant mortality), health expenses and standards of living (to be defined together).

To set the stage for this future impact evaluation, the current research proposal will need to:

| — | reconstruct the theory of change based on the relevant academic literature and expected results of the project, |
| --- | --- |

—

reconstruct the theory of change based on the relevant academic literature and expected results of the project,

| — | prepare a rigorous impact evaluation design (including identification of a valid counterfactual in collaboration with the project promoter), |
| --- | --- |

—

prepare a rigorous impact evaluation design (including identification of a valid counterfactual in collaboration with the project promoter),

| — | prior to the implementation of the intervention, carry out a baseline survey of both groups – i.e. those who will benefit from the intervention and the comparison households (appropriate data collection mechanisms, identification of relevant sex-disaggregated indicators to effectively estimate the possible differential effects on women and men, etc.). |
| --- | --- |

—

prior to the implementation of the intervention, carry out a baseline survey of both groups – i.e. those who will benefit from the intervention and the comparison households (appropriate data collection mechanisms, identification of relevant sex-disaggregated indicators to effectively estimate the possible differential effects on women and men, etc.).

Those steps need to take place at the onset of the project to enable the EIB to conduct a consistent follow-up/endline survey (5) to conclude the evaluation of the socioeconomic impact and improvements in women’s economic resilience and well-being after project completion.

3.   Challenges and limitations

Three main challenges will need to be addressed by the research team. First, the identification of an optimal methodology for carrying out an ex ante estimation of the impact of water infrastructure investments in urban areas on wider societal gender inequality and the selection of the most appropriate indicators that could apply in this context. Since this methodological challenge is recurrent when appraising EIB support, the research team should develop a rigorous methodology, backed by academic research, which can be used in a simple way to inform EIB gender tagging and project selection and design where relevant.

Second, given the long-term nature of the water project in Madagascar, the three-year time frame for this assignment will only enable the initial stages of the impact evaluation to be carried out. However, the research work is expected to collect data at the onset of the project, when the project has not yet influenced the outcome variables of interest (i.e. women’s economic resilience and well-being). This, combined with the identification of a valid comparison group, will make it possible to compare baseline data with the same indicators collected ex-post. The research team is expected to engage in discussions with the relevant EIB services and project promoter to explain the overall approach and its implications.

Finally, infrastructure investments, including water projects such as this one, have the potential to have indirect and induced impacts on women’s prospects, and these are harder to measure. Nevertheless, they are also important to consider in terms of both risks and opportunities in designing projects.

4.   Deliverables and team composition

Given the three-year time frame, the research work should include intermediate deliverables and final deliverables.

Year 1:

| — | A review of the related academic literature (6). |
| --- | --- |

—

A review of the related academic literature (6).

| — | Empirical analysis:






  — | a theory of change of the JIRAMA water project in Madagascar based on a participatory approach and a conceptual framework investigating how women’s improved access to drinking water enhances their economic resilience and well-being, and the relevance of time savings in this regard, |
| --- | --- | --- |

—

Empirical analysis:

—

a theory of change of the JIRAMA water project in Madagascar based on a participatory approach and a conceptual framework investigating how women’s improved access to drinking water enhances their economic resilience and well-being, and the relevance of time savings in this regard,

| — | formulation of precise research questions and related indicators in collaboration with the EIB, |
| --- | --- |

—

formulation of precise research questions and related indicators in collaboration with the EIB,

| — | a methodological note on the design of the impact evaluation resulting from discussions with the EIB project team and local partners, specifying the approach (e.g. quasi-experimental) and the identification of a valid control or comparison group, preliminary interviews with relevant stakeholders, the preparation of qualitative and quantitative data collection tools/survey questionnaires/interview guides and required indicators, the data collection methods (e.g. sampling strategy and power calculations, pilot mission, enumerator training, potential translation of the questionnaire into Malagasy, organisation of focus group discussions, use of tablets, etc.) and a detailed calendar of the activities. |
| --- | --- |

—

a methodological note on the design of the impact evaluation resulting from discussions with the EIB project team and local partners, specifying the approach (e.g. quasi-experimental) and the identification of a valid control or comparison group, preliminary interviews with relevant stakeholders, the preparation of qualitative and quantitative data collection tools/survey questionnaires/interview guides and required indicators, the data collection methods (e.g. sampling strategy and power calculations, pilot mission, enumerator training, potential translation of the questionnaire into Malagasy, organisation of focus group discussions, use of tablets, etc.) and a detailed calendar of the activities.

Year 2:

| — | Baseline data collection (timing to align with the project timeline). |
| --- | --- |

—

Baseline data collection (timing to align with the project timeline).

| — | Construction of the indicators, data cleaning and creation of the project-relevant databases (e.g. in stata, R or Excel format). |
| --- | --- |

—

Construction of the indicators, data cleaning and creation of the project-relevant databases (e.g. in stata, R or Excel format).

Year 3:

| — | A report presenting descriptive statistics and analytics of the baseline data and including triangulation of various data sources (qualitative and quantitative). The analysis will need to check whether characteristics between treatment and control groups are balanced. |
| --- | --- |

—

A report presenting descriptive statistics and analytics of the baseline data and including triangulation of various data sources (qualitative and quantitative). The analysis will need to check whether characteristics between treatment and control groups are balanced.

| — | A methodological note on the implications for the EIB in the appraisal of water infrastructure projects based on the study results. This note should also provide guidance on the best indicator for the EIB to use as a proxy of gender equality impact through investments in infrastructure, in particular considering time poverty (7) as an indicator of particular interest to the EIB. It should provide recommendations on how such an indicator can be tracked (including data sources for triangulation, etc.). |
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A methodological note on the implications for the EIB in the appraisal of water infrastructure projects based on the study results. This note should also provide guidance on the best indicator for the EIB to use as a proxy of gender equality impact through investments in infrastructure, in particular considering time poverty (7) as an indicator of particular interest to the EIB. It should provide recommendations on how such an indicator can be tracked (including data sources for triangulation, etc.).

| — | Dissemination of research findings with the EIB and relevant counterparts (such as seminars/conferences/preparation of infographics or a short video). |
| --- | --- |

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Dissemination of research findings with the EIB and relevant counterparts (such as seminars/conferences/preparation of infographics or a short video).

Moreover, we recommend including in the team at least one profile with hands-on and demonstrated experience in conducting rigorous impact evaluations with a counterfactual approach. Team members with relevant experience in gender analysis and/or assessment of water projects would be a strong advantage. Similarly, team members with local experience and/or a good knowledge of the context of Madagascar would facilitate the implementation of the baseline survey.

Proposals should be submitted in English by 30 April 2021, 24:00 (CET). Proposals submitted after this date will not be considered. Proposals should be sent by email to:

| | Events.EIBInstitute@eib.org |
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Events.EIBInstitute@eib.org

| | For more information on the EIBURS selection process and on the EIB Institute, please visit: https://institute.eib.org/ |
| --- | --- |

For more information on the EIBURS selection process and on the EIB Institute, please visit: https://institute.eib.org/

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(1)  ADB (2019), ‘Gender in Infrastructure: Lessons from Central and West Asia’.

(2)  Jacobson, J., Mohun, R., and Sajjad, F. (2016), ‘Infrastructure: A Game Changer for Women’s Economic Empowerment’, UKaid and ICED.

(3)  The project consists of an increase in production and water treatment capacity, storage capacity, and transport and distribution capacity. The project is expected to lead to an improvement in access to drinking water for a population of about 2 million inhabitants.

(4)  3ie (2018), ‘Water, Sanitation and Hygiene Evidence Gap Map: 2018 update’, London: International Initiative for Impact Evaluation (3ie), available here and summary findings here.

(5)  The follow-up/endline survey is not part of the current assignment.

(6)  In addition to a review of ex ante social/gender impact assessment approaches and related proxy indicators used by other financial institutions, including but not limited to IFIs, MDBs and DFIs, and by academic/research/think tank institutions (e.g. European Institute for Gender Equality (EIGE) and GROW in Canada).

(7)  More time spent working in unpaid work-related activities means less leisure time and less time to engage in productive activities, and therefore higher ‘time poverty’ and often poverty itself. Women’s time poverty can be due to gender/social norms that mean that women disproportionately engage in certain unpaid care responsibilities or activities that take time away from more productive ones. These can relate to lack of access to care services, poor access to safe public transport and, outside the European Union in particular, to firewood and water collection.

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PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 5.3.2021 | EN | Official Journal of the European Union | C 76/21 |
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5.3.2021

EN

Official Journal of the European Union

C 76/21

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Prior notification of a concentration

(Case M.9926 — ADI/Maxim)

(Text with EEA relevance)

(2021/C 76/07)

1.

This notification concerns the following undertakings:

| — | Analog Devices, Inc. (ADI, USA), |
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Analog Devices, Inc. (ADI, USA),

| — | Maxim Integrated Prodcuts (Maxim, USA). |
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Maxim Integrated Prodcuts (Maxim, USA).

ADI acquires within the meaning of Article 3(1)(b) of the Merger Regulation sole control of the whole of Maxim.

The concentration is accomplished by way of purchase of shares.

2.

| — | for ADI: ADI designs, manufactures and markets a broad portfolio of solutions, including integrated circuits, algorithms, software and subsystems that use analogue, mixed-signal and digital signal processing technologies. ADI’s products serve customers across the globe in a number of sectors, including the industrial, communications, automotive and consumer sectors. |
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for ADI: ADI designs, manufactures and markets a broad portfolio of solutions, including integrated circuits, algorithms, software and subsystems that use analogue, mixed-signal and digital signal processing technologies. ADI’s products serve customers across the globe in a number of sectors, including the industrial, communications, automotive and consumer sectors.

| — | for Maxim: Maxim designs, develops, manufactures and markets a broad range of analogue, mixed-signal and digital integrated circuits. Its products serve customers in diverse geographic locations in the automotive, communications and data centre, computing, consumer and industrial sectors. |
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for Maxim: Maxim designs, develops, manufactures and markets a broad range of analogue, mixed-signal and digital integrated circuits. Its products serve customers in diverse geographic locations in the automotive, communications and data centre, computing, consumer and industrial sectors.

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved.

4.

Observations must reach the Commission not later than 10 days following the date of this publication. The following reference should always be specified:

M.9926 ADI/Maxim

Observations can be sent to the Commission by email, by fax, or by post. Please use the contact details below:

Email: COMP-MERGER-REGISTRY@ec.europa.eu

Fax +32 22964301

Postal address:

| European Commission |
| --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

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(1)  OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).

1

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OTHER ACTS

European Commission

| 5.3.2021 | EN | Official Journal of the European Union | C 76/23 |
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5.3.2021

EN

Official Journal of the European Union

C 76/23

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Publication of the amended single document following the approval of a minor amendment pursuant to the second subparagraph of Article 53(2) of Regulation (EU) No 1151/2012

(2021/C 76/08)

The European Commission has approved this minor amendment in accordance with the third subparagraph of Article 6(2) of Commission Delegated Regulation (EU) No 664/2014 (1).

The application for approval of this minor amendment can be consulted in the Commission’s eAmbrosia database.

SINGLE DOCUMENT

‘JIHOČESKÁ ZLATÁ NIVA’

EU No: PGI-CZ-0406-AM02 – 28.8.2020

PDO ( ) PGI (X)

1.   Name(s)

‘Jihočeská Zlatá Niva’

2.   Member State or third country

Czech Republic

3.   Description of the agricultural product or foodstuff

3.1.   Type of product

Class 1.3. Cheeses

3.2.   Description of the product to which the name in (1) applies

Outside appearance: The cheese is cylindrical, having a diameter of 180-200 mm and a height of approximately 10 cm (weight approximately 2,8 kg), with signs of surface treatment by washing or scraping; the bluish-green mould throughout the inside of the cheese and the smear covering part of its surface are not detrimental. The surface of the cheese may be cream to light brownish in colour.

Internal appearance: The inside of the cheese is off-white to cream in colour, with a regular green to bluish-green marbling of mould in the paste and recognisable pierce marks.

Consistency: milder than ‘Jihočeská Niva’ (with a 50 % FCDM), sticky, evenly ripened; the presence of foreign mould is not permitted.

Flavour and aroma: salty, pungent, aromatic, with a sharp finish, characteristic of cultured Penicillium roqueforti mould.

Form in which the product is marketed: the cheese is marketed whole, in halves or in portions of various weights.

Physico-chemical requirements:

Drymatter content: 52 %. permissible negative divergence in dry-matter content: – 1 %, positive divergences in dry-matter content are not detrimental.

Fat content in dry matter: 60 %. permissible range of FCDM values: 60 % to < 65 %.

Salt content: from 2,5 % to 6 %

Microbiological characteristics:

The cheese contains cultured Penicillium roqueforti mould PY or PV, CB or PR1 (up to PR4). Other strains of Penicillium roqueforti mould produced by other producers, whose properties correspond to the strains listed here, may also be used. In addition, in terms of microbiological requirements, the cheese meets the usual criteria for food safety and production-process hygiene.

3.3.   Feed (for products of animal origin only) and raw materials (for processed products only)

The basic raw material used in the production of this natural cheese with mould inside it is dairy-processed cow’s milk. Only milk from the defined area is used. Other raw materials are: Penicillium roqueforti mould PY or PV, CB or PR1 (up to PR4), (as well as other Penicilium roqueforti strains from other producers, whose properties correspond to the strains listed here), salt, dairy cultures, rennet and calcium chloride.

3.4.   Specific steps in production that must take place in the defined geographical area

The basic raw material, i.e. milk, must come from the defined geographical area. The entire production and ripening process must take place in the defined area so that maximum use can be made of long-standing local experience and the original ripening cellars.

Dairy-processed milk with a fat content of 5,35 % (with a possible variation of +/– 0,15 %) is fed into the cheese-making machine and commonly used starter cultures, which ensure good acidification throughout the production and ripening of the cheese, are added. The characteristic taste of ‘Jihočeská Zlatá Niva’ is imparted by cultured Penicillium roqueforti mould, which has been used for several decades (the culture stock is commonly available for use in the food industry). After the rennet has been added and the milk has curdled, the resulting curd grains are packed into cylindrical moulds. The whey is drained off and the microflora culture developed at a defined temperature. The cheese is salted either in two stages (first it is placed in a brine bath, then it is rubbed with coarse-grained salt), or by applying salt to the surface. In the past, ripening took place only in natural ripening cellars that were hollowed out of limestone rock. In 2005, owing to an increase in blue cheese production, air-conditioned ripening cellars equipped with temperature and humidity controls were built. The cheese is ripened in the cellars for at least 6 weeks.

The surface of the ripened cheese is washed or scraped.

3.5.   Specific rules concerning slicing, grating, packaging, etc. of the product the registered name refers to

In view of the biotechnological nature of the product, blue cheese must be packed directly at the production facility. This is also necessary to maintain product quality and hygiene and to prevent the cheese from being confused with cheese that is made in a different area and, last but not least, to permit better traceability of the product.

The entire cylinder or part thereof is packed in aluminium foil or special oxygen-permeable film. A further part of the production is cut up into portions and packed in plastic tubs covered with printed plastic film.

The product packaging must be intact, clean and correctly labelled.

3.6.   Specific rules concerning labelling of the product the registered name refers to

The designation ‘Jihočeská Zlatá Niva’ is clearly marked on the product packaging.

4.   Concise definition of the geographical area

The geographical area is the southern Bohemia region, whose borders are defined by Act No 36/1960 on the territorial division of the State, as amended.

5.   Link with the geographical area

The southern Bohemia region is one of the Czech Republic’s least polluted areas. It has always been considered to be a predominantly agricultural area. This is still the case today.

The milk comes from southern Bohemia. The unique flora of the pastures, which are located in the Novohradské Hory [Nové Hrady Moutains], Blanský les [Blanský Forest] and Šumava [Bohemian Forest] protected areas, has a positive effect on the taste of the milk.

This varied, rugged terrain with unspoilt forests, meadows, pastures and clean water courses is characterised by a very clean environment, particularly around Český Krumlov and in the Šumava hills (declared a UNESCO Biosphere Reserve in 1990). Proof of the high value of southern Bohemia’s natural environment lies in the large number of officially designated protected areas, two of which have UNESCO-protected status.

They contain species-rich pastures, in particular mesophilic meadows, which are home to flora specific to this area. Short-stalked plants (mat-grass, fescues, etc.) with high varietal diversity are characteristic, alongside certain rare varieties typical of the area. One specific endemic plant is Phyteuma nigrum, and others include Gentiana pannonica, Gentiana cruciata, Ligusticum mutellina, Arnica montana, Gentianella praecox subsp. Bohemica, Carex michelii, Andropogon ischaemum, Veronica teucrium, Stachys recta, Koeleria pyramidata, etc.

Of course, local people’s experience in producing this cheese, handed down from generation to generation, has also had a major influence on the quality and properties of ‘Jihočeská Zlatá Niva’.

These factors clearly distinguish the defined area from surrounding areas.

‘Jihočeská Zlatá Niva’ cheese is characterised by very high-quality processing and by its taste, with a balanced dry-matter, fat and salt content; it has been made for several decades by the process referred to in (3.5). The basis for the product is milk from southern Bohemia.

‘Jihočeská Zlatá Niva’ blue cheese has been produced at the Český Krumlov plant using the same production method since 1951. Numerous references in the press attest to the history of Niva cheese production. The cheese was named after the Šumava meadows and pastures that are the source of the main ingredient, i.e. cow’s milk. The unique local flora has a positive effect on the taste of the milk and hence also on the final product.

‘Jihočeská Zlatá Niva’ blue cheese is very highly regarded on the Czech market both by the general public and by dairy-industry specialists. For many years ‘Jihočeská Zlatá Niva’ has been judged by panels of experts at nationwide cheese shows to be amongst the very best in the ‘blue cheese’ category. ‘Jihočeská Zlatá Niva’ is similarly highly rated by the general public.

Reference to publication of the specification

(the second subparagraph of Article 6(1) of the Regulation)

https://isdv.upv.cz/doc/vestnik/2020/vestnik_UPV_202010.pdf#page=157

Official Journal No 10 of 4.3.2020, p. 157 ff.

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(1)  OJ L 179, 19.6.2014, p. 17.

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