title: 2010/674/EU: Council Decision of 26 July 2010 on the signing and provisional application of an Agreement between the European Union, Iceland, Liechtenstein and Norway on an EEA Financial Mechanism 2009-2014, an Agreement between the European Union and Norway on a Norwegian Financial Mechanism for the period 2009-2014, an Additional Protocol to the Agreement between the European Economic Community and Iceland, concerning special provisions applicable to imports into the European Union of certain fish and fisheries products for the period 2009-2014, and an Additional Protocol to the Agreement between the European Economic Community and Norway, concerning special provisions applicable to imports into the European Union of certain fish and fisheries products for the period 2009-2014#Agreement between the European Union, Iceland, the Principality of Liechtenstein and the Kingdom of Norway on an EEA Financial Mechanism 2009-2014#Agreement between the Kingdom of Norway and the European Union on a Norwegian Financial Mechanism for the period 2009-2014#Additional Protocol to the Agreement between the European Economic Community and the Republic of Iceland#Additional Protocol to the Agreement between the European Economic Community and the Kingdom of Norway

text:
               9.11.2010

               EN

               Official Journal of the European Union

               L 291/1

         COUNCIL DECISION
   of 26 July 2010
   on the signing and provisional application of an Agreement between the European Union, Iceland, Liechtenstein and Norway on an EEA Financial Mechanism 2009-2014, an Agreement between the European Union and Norway on a Norwegian Financial Mechanism for the period 2009-2014, an Additional Protocol to the Agreement between the European Economic Community and Iceland, concerning special provisions applicable to imports into the European Union of certain fish and fisheries products for the period 2009-2014, and an Additional Protocol to the Agreement between the European Economic Community and Norway, concerning special provisions applicable to imports into the European Union of certain fish and fisheries products for the period 2009-2014
   (2010/674/EU)
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 217 in conjunction with Article 218(5) thereof,
   Having regard to the proposal from the European Commission,
   Whereas:

               (1)

               The following financial mechanisms and cooperation programmes expired on 30 April 2009:

                           —

                           the EEA Financial Mechanism 2004-2009 provided for in Protocol 38a to the Agreement on the European Economic Area (‘EEA Agreement’) (1), as subsequently supplemented with an addendum in 2007 upon Bulgaria and Romania becoming contracting parties to the EEA Agreement (2),

                           —

                           the Norwegian Financial Mechanism 2004-2009 provided for in the Agreement between the Kingdom of Norway and the European Community on a Norwegian financial mechanism for the period 2004-2009 (3),

                           —

                           the Cooperation Programme mentioned in the Agreement in the form of an Exchange of Letters between the European Community and the Kingdom of Norway concerning a Cooperation Programme for Economic Growth and Sustainable Development in Bulgaria (4), and

                           —

                           the Cooperation Programme mentioned in the Agreement in the form of an Exchange of Letters between the European Community and the Kingdom of Norway concerning a Cooperation Programme for Economic Growth and Sustainable Development in Romania (5).

               (2)

               The need to alleviate economic and social disparities within the European Economic Area persists. Therefore a new mechanism for the financial contributions of the EEA EFTA States and a new Norwegian financial mechanism should be established.

               (3)

               To this end, the Commission has negotiated, on behalf of the Union, an agreement with Iceland, Liechtenstein and Norway on a new EEA financial mechanism for the period 2009-2014 as well as an annex to that agreement. The annex will take the form of a protocol, to be named Protocol 38b to the EEA Agreement. To the same end, the Commission has also negotiated, on behalf of the Union, an agreement with Norway on a new Norwegian financial mechanism for the period 2009-2014.

               (4)

               Subject to their conclusion at a later date, these agreements should be signed.

               (5)

               The special provisions applicable to imports into the Union of certain fish and fisheries products originating in Iceland and Norway, provided for in the following protocols, expired on 30 April 2009 and should be reviewed in accordance with Article 2 of each of those protocols:

                           —

                           Additional Protocol to the Agreement between the European Economic Community and the Republic of Iceland consequent on the accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic to the European Union (6),

                           —

                           Additional Protocol to the Agreement between the European Economic Community and the Kingdom of Norway consequent on the accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic to the European Union (7),

                           —

                           Additional Protocol to the Agreement between the European Economic Community and Iceland consequent on the Accession of the Republic of Bulgaria and Romania to the European Union (8),

                           —

                           Additional Protocol to the Agreement between the European Economic Community and the Kingdom of Norway consequent on the accession of the Republic of Bulgaria and Romania to the European Union (9).

               (6)

               To this end, the Commission has negotiated, on behalf of the Union, new additional protocols to the free trade agreements respectively with Iceland and Norway, to lay down special provisions applicable to imports into the Union of certain fish and fisheries products originating in Iceland and Norway for the period 2009-2014.

               (7)

               Subject to their conclusion at a later date, these additional protocols should be signed.

               (8)

               The replacement of the existing financial mechanisms by new mechanisms, which relate to different time periods, different amounts of funds, and different implementing provisions, as well as the renewal and extension of the concessions relating to certain fish and fisheries products, taken as a whole, constitute an important development of the association with the EEA EFTA States, which justifies the recourse to Article 217 of the Treaty on the Functioning of the European Union.

               (9)

               Pending the completion of the procedures required for their conclusion, the Agreements referred to in recital 4 and the Protocols referred to in recital 7 should be applied on a provisional basis,

         HAS ADOPTED THIS DECISION:
   Article 1
   The signing of the following agreements and protocols is hereby approved on behalf of the Union, subject to their conclusion:

               —

               Agreement between the European Union, Iceland, the Principality of Liechtenstein and the Kingdom of Norway on an EEA Financial Mechanism 2009-2014 and the Annex thereto,

               —

               Agreement between the European Union and the Kingdom of Norway on a Norwegian Financial Mechanism for the period 2009-2014,

               —

               Additional Protocol to the Agreement between the European Economic Community and the Republic of Iceland and the Annex thereto,

               —

               Additional Protocol to the Agreement between the European Economic Community and the Kingdom of Norway and the Annex thereto.

         The texts of the Agreements and Additional Protocols and the Annexes thereto are attached to this Decision.
   Article 2
   The President of the Council is hereby authorised to designate the person(s) empowered to sign these Agreements and Protocols on behalf of the Union, subject to their conclusion.
   Article 3
   Pending the completion of the procedures for their conclusion, the Agreements and Protocols referred to in Article 1, shall be applied on a provisional basis as from the following dates:

               —

               the Agreement between the European Union, Iceland, the Principality of Liechtenstein and the Kingdom of Norway on an EEA Financial Mechanism 2009-2014 and the Annex thereto, as from the first day of the first month following the deposit of the last notification to this effect,

               —

               the Agreement between the European Union and the Kingdom of Norway on a Norwegian Financial Mechanism for the period 2009-2014, as from the first day of the first month following the deposit of the last notification to this effect,

               —

               the Additional Protocol to the Agreement between the European Economic Community and the Republic of Iceland and the Annex thereto, as from the first day of the third month following the deposit of the last notification to this effect,

               —

               the Additional Protocol to the Agreement between the European Economic Community and the Kingdom of Norway and the Annex thereto, as from the first day of the third month following the deposit of the last notification to this effect.

         Article 4
   This Decision shall enter into force on the day of its adoption.

      Done at Brussels, 26 July 2010.

            For the Council

            The President

         S. VANACKERE

      (1)  OJ L 130, 29.4.2004, p. 14.

      (2)  OJ L 221, 25.8.2007, p. 18.

      (3)  OJ L 130, 29.4.2004, p. 81.

      (4)  OJ L 221, 25.8.2007, p. 46.

      (5)  OJ L 221, 25.8.2007, p. 52.

      (6)  OJ L 130, 29.4.2004, p. 85.

      (7)  OJ L 130, 29.4.2004, p. 89.

      (8)  OJ L 221, 25.8.2007, p. 58.

      (9)  OJ L 221, 25.8.2007, p. 62.

      AGREEMENT
      between the European Union, Iceland, the Principality of Liechtenstein and the Kingdom of Norway on an EEA Financial Mechanism 2009-2014
      THE EUROPEAN UNION,
      ICELAND,
      THE PRINCIPALITY OF LIECHTENSTEIN,
      THE KINGDOM OF NORWAY,
      WHEREAS the Parties to the Agreement on the European Economic Area (‘EEA Agreement’) agreed on the need to reduce the economic and social disparities between their regions with a view to promoting a continuous and balanced strengthening of trade and economic relations between them,
      WHEREAS, in order to contribute to that objective, the EFTA States have established a Financial Mechanism in the context of the European Economic Area,
      WHEREAS the provisions governing the EEA Financial Mechanism for the period 2004-2009 have been set out in Protocol 38a and the Addendum to Protocol 38a to the EEA Agreement,
      WHEREAS the need to alleviate economic and social disparities within the European Economic Area persists, and therefore a new mechanism for the financial contributions of the EEA EFTA States should be established for the period 2009-2014,
      HAVE DECIDED TO CONCLUDE THE FOLLOWING AGREEMENT:
      Article 1
      The text of Article 117 of the EEA Agreement shall be replaced by the following:

         ‘Provisions governing the Financial Mechanisms are set out in Protocol 38, Protocol 38a and the Addendum to Protocol 38a, and Protocol 38b.’.

      Article 2
      A new Protocol 38b shall be inserted after Protocol 38a to the EEA Agreement. The text of Protocol 38b is provided for in the Annex to this Agreement.
      Article 3
      This Agreement shall be ratified or approved by the Parties in accordance with their own procedures. The instruments of ratification or approval shall be deposited with the General Secretariat of the Council of the European Union.
      It shall enter into force on the first day of the second month after the last instrument of ratification or approval has been deposited.
      Pending the completion of the procedures referred to in paragraphs 1 and 2, this Agreement shall be applied on a provisional basis as from the first day of the first month following the deposit of the last notification to this effect.
      Article 4
      This Agreement, drawn up in a single original in the Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Italian, Latvian, Lithuanian, Hungarian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish, Icelandic and Norwegian languages, the text in each of these languages being equally authentic, shall be deposited with the General Secretariat of the Council of the European Union, which will remit a certified copy to each of the Parties to this Agreement.

         Съставено в Брюксел на двадесет и осми юли две хиляди и десета година и деветнадесети август две хиляди и десета година.
         Hecho en Bruselas, el veintiocho de julio de dos mil diez y el diecinueve de agosto de dos mil diez.
         V Bruselu dne 28. července 2010 a 19. srpna 2010.
         Udfærdiget i Bruxelles, den 28. juli 2010 og den 19. august 2010.
         Geschehen zu Brüssel am 28. Juli 2010 und am 19. August 2010.
         Brüsselis kahe tuhande kümnenda aasta juulikuu kahekümne kaheksandal ja augustikuu üheksateistkümnendal päeval
         Έγινε στις Βρυξέλλες, στις 28 Iουλίου 2010 και στις 19 Αυγούστου 2010.
         Done at Brussels on the twenty-eighth day of July and on the nineteenth day of August in the year two thousand and ten.
         Fait à Bruxelles, le vingt-huit juillet deux mil dix et le dix-neuf août deux mil dix.
         Fatto a Bruxelles, addì ventotto luglio duemiladieci e diciannove agosto duemiladieci.
         Briselē, 2010. gada 28. jūlijā un 2010. gada 19. augustā
         Priimta Briuselyje 2010 m. liepos 28 d. ir 2010 m. rugpjūčio 19 d.
         Kelt Brüsszelben, a kétezer-tizedik év július havának huszonnyolcadik napján és a kétezer-tizedik év augusztus havának tizenkilencedik napján.
         Magħmul fi Brussell, it-28 ta’ Lulju 2010 u d-19 ta’ Awwissu 2010.
         Gedaan te Brussel, 28 juli 2010 en 19 augustus 2010.
         Sporządzono w Brukseli dnia 28 lipca 2010 r. i 19 sierpnia 2010 r.
         Feito em Bruxelas, em vinte e oito de Julho de dois mil e dez e em dezanove de Agosto de dois mil e dez.
         Întocmit la Bruxelles, 28 iulie 2010 și 19 august 2010.
         V Bruseli dvadsiateho ôsmeho júla dvetisícdesať a devätnásteho augusta dvetisícdesať.
         V Bruslju, 28. julija 2010 in 19. avgusta 2010.
         Tehty Brysselissä, kahdentenakymmenentenäkahdeksantena päivänä heinäkuuta vuonna kaksituhattakymmenen ja yhdeksäntenätoista päivänä elokuuta vuonna kaksituhattakymmenen
         Som skedde i Bryssel den tjugoåttonde juli tjugohundratio och den nittonde augusti tjugohundratio.
         Gert í Brussel, 28. júlí 2010 og 19. ágúst 2010.
         Utferdiget i Brussel, den 28. juli 2010 og den 19. august 2010.

            За Европейския съюз
            Por la Unión Europea
            Za Evropskou unii
            For Den Europæiske Union
            Für die Europäische Union
            Euroopa Liidu nimel
            Για την Ευρωπαϊκή Ένωση
            For the European Union
            Pour l’Union européenne
            Per l’Unione europea
            Eiropas Savienības vārdā –
            Europos Sąjungos vardu
            Az Európai Unió részéről
            Għall-Unjoni Ewropea
            Voor de Europese Unie
            W imieniu Unii Europejskiej
            Pela União Europeia
            Pentru Uniunea Europeană
            Za Európsku úniu
            Za Evropsko unijo
            Euroopan unionin puolesta
            För Europeiska unionen

            Fyrir Ísland

            Für das Fürstentum Liechtenstein

            For Konveriket Norge

         ANNEX

            PROTOCOL 38 B

            ON THE EEA FINANCIAL MECHANISM (2009-2014)

         Article 1
         Iceland, Liechtenstein and Norway (‘the EFTA States’) shall contribute to the reduction of economic and social disparities in the European Economic Area and to the strengthening of their relations with the Beneficiary States, through financial contributions in the priority sectors listed in Article 3.
         Article 2
         The total amount of the financial contribution provided for in Article 1 shall be EUR 988,5 million, to be made available for commitment in annual tranches of EUR 197,7 million over the period running from 1 May 2009 to 30 April 2014, inclusive.
         Article 3
         1.   The financial contributions shall be available in the following priority sectors:

                     (a)

                     Environmental protection and management;

                     (b)

                     Climate change and renewable energy;

                     (c)

                     Civil society;

                     (d)

                     Human and social development;

                     (e)

                     Protecting cultural heritage.

               2.   Academic research may be eligible for funding in so far as it is targeted at one or more of the priority sectors.
         3.   The indicative allocation target for each Beneficiary State is at least 30 percent for priority sectors (a) and (b) combined, and 10 per cent for priority sector (c). The priority sectors shall, in accordance with the procedure referred to in Article 8 paragraph 2, be chosen, concentrated and adapted in a flexible manner, according to the different needs in each Beneficiary State, taking into account its size and the amount of the contribution.
         Article 4
         1.   The EFTA contribution shall not exceed 85 percent of programme cost. It may in special cases be up to 100 per cent of programme cost.
         2.   The applicable rules on state aid shall be complied with.
         3.   The European Commission shall screen all programmes and any substantial change in a programme for their compatibility with the European Union's objectives.
         4.   The responsibility of the EFTA States for the projects is limited to providing funds according to the agreed plan. No liability to third parties will be assumed.
         Article 5
         The funds shall be made available to the following Beneficiary States: Bulgaria, Czech Republic, Estonia, Greece, Spain, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Portugal, Romania, Slovenia and Slovakia.
         EUR 45,85 million shall be allocated to Spain for transitional support for the period 1 May 2009–31 December 2013. While taking into account transitional adjustments, the remaining funds shall be made available in accordance with the following distribution:

                     Funds
                     (million EUR)

                     Bulgaria

                     78,60

                     Czech Republic

                     61,40

                     Estonia

                     23,00

                     Greece

                     63,40

                     Cyprus

                     3,85

                     Latvia

                     34,55

                     Lithuania

                     38,40

                     Hungary

                     70,10

                     Malta

                     2,90

                     Poland

                     266,90

                     Portugal

                     57,95

                     Romania

                     190,75

                     Slovenia

                     12,50

                     Slovakia

                     38,35

               Article 6
         With a view to reallocating any non-committed available funds to high priority projects of any Beneficiary State, a review shall be carried out in November 2011 and again in November 2013.
         Article 7
         1.   The financial contribution provided for in this Protocol shall be closely coordinated with the bilateral contribution from Norway provided for by the Norwegian Financial Mechanism.
         2.   In particular, the EFTA States shall ensure that the application procedures and implementation modalities are essentially the same for both financial mechanisms referred to in the previous paragraph.
         3.   Any relevant changes in the European Union's cohesion policies shall be taken into account, as appropriate.
         Article 8
         The following shall apply to the implementation of the EEA Financial Mechanism:

                     1.

                     The highest degree of transparency, accountability and cost efficiency shall be applied in all implementation phases, as well as principles of good governance, sustainable development and gender equality. The objectives of the EEA Financial Mechanism shall be pursued in the framework of close cooperation between the Beneficiary States and the EFTA States.

                     2.

                     In order to ensure efficient and targeted implementation, and taking into account national priorities, the EFTA States shall conclude with each Beneficiary State a Memorandum of Understanding that shall set out the multi-annual programming framework and the structures for management and control.

                     3.

                     After having concluded the Memorandum of Understanding, the Beneficiary State shall submit programme proposals. The EFTA States will appraise and approve the proposals and conclude grant agreements with the Beneficiary States for each programme. The level of detail in the programme shall take into account the size of the contribution. Within programmes, projects may in exceptional cases be specified, including conditions for their selection, approval and control, in accordance with the provisions for implementation referred to in paragraph 8.
                     The implementation of the agreed programmes shall be the responsibility of the Beneficiary States. The Beneficiary States shall provide for an appropriate management and control system in order to ensure a sound implementation and management system.

                     4.

                     Partnerships shall, where appropriate, be applied in the preparation, implementation, monitoring and evaluation of the financial contribution in order to ensure broad participation. Partners may include, inter alia, local, regional and national levels, as well as the private sector, civil society and social partners in the Beneficiary States and the EFTA States.

                     5.

                     The control system provided for the management of the EEA Financial Mechanism shall ensure the respect of the principle of sound financial management. The EFTA States may carry out controls according to their internal requirements. The Beneficiary States shall provide all necessary assistance, information and documentation to this effect. The EFTA States may suspend financing and require recovery of funds in the case of irregularities.

                     6.

                     Any project under the multi-annual programming framework in the Beneficiary States may be implemented in cooperation between entities based in the Beneficiary States and in the EFTA States, in accordance with the applicable rules on public procurement.

                     7.

                     The management costs of the EFTA States shall be covered by the overall amount referred to in Article 2 and will be specified in the provisions for the implementation referred to in paragraph 8.

                     8.

                     The EFTA States shall establish a Committee for the overall management of the EEA Financial Mechanism. Further provisions for the implementation of the EEA Financial Mechanism will be issued by the EFTA States after consultation with the Beneficiary States. The EFTA States shall endeavour to issue these provisions before the signing of the Memoranda of Understanding.

               Article 9
         At the end of the five-year period and without prejudice to the rights and obligations under the Agreement, the Contracting Parties will, in the light of Article 115 of the Agreement, review the need to address economic and social disparities within the European Economic Area.

      AGREEMENT
      between the Kingdom of Norway and the European Union on a Norwegian Financial Mechanism for the period 2009-2014
      Article 1
      The Kingdom of Norway undertakes to contribute for a five year period to the reduction of economic and social disparities in the European Economic Area, and to the strengthening of its relations with the Beneficiary States, through a separate Norwegian Financial Mechanism in the priority sectors listed in Article 3.
      Article 2
      The total amount of the financial contribution provided for in Article 1 shall be EUR 800 million, to be made available for commitment in annual tranches of EUR 160 million over the period running from 1 May 2009 to 30 April 2014, inclusive.
      Article 3
      The financial contributions shall be available in the following priority sectors:

                  (a)

                  Carbon Capture and Storage;

                  (b)

                  Green Industry Innovation;

                  (c)

                  Research and Scholarship;

                  (d)

                  Human and Social Development;

                  (e)

                  Justice and Home Affairs;

                  (f)

                  Promotion of Decent Work and Tripartite Dialogue.

            The allocation target for priority sector (a) shall be at least 20 percent. Due account will be taken of the different needs and the size of each Beneficiary State.
      One per cent of the allocation to each Beneficiary State shall be set aside for a fund for the Promotion of Decent Work and Tripartite Dialogue, to be operated by an entity designated by the Kingdom of Norway, and in accordance with the distribution key referred to in Article 5.
      Article 4
      The contribution from the Kingdom of Norway shall not exceed 85 percent of programme cost. It may in special cases be up to 100 percent of programme cost.
      The applicable rules on state aid shall be complied with.
      The European Commission shall screen all programmes and any substantial change in a programme for their compatibility with the European Union's objectives.
      The responsibility of the Kingdom of Norway for the projects is limited to providing funds according to the agreed plan. No liability to third parties will be assumed.
      Article 5
      The funds shall be made available to the following Beneficiary States: Bulgaria, Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Romania, Slovenia and Slovakia, in accordance with the following distribution:

                  Beneficiary State

                  Funds (million EUR)

                  Bulgaria

                  48,00

                  Cyprus

                  4,00

                  Czech Republic

                  70,40

                  Estonia

                  25,60

                  Latvia

                  38,40

                  Lithuania

                  45,60

                  Hungary

                  83,20

                  Malta

                  1,60

                  Poland

                  311,20

                  Romania

                  115,20

                  Slovenia

                  14,40

                  Slovakia

                  42,40

            Article 6
      With a view to reallocate any non-committed available funds to high priority projects of any Beneficiary State, a review shall be carried out in November 2011 and again in November 2013.
      Article 7
      The financial contribution provided for in Article 1 shall be closely coordinated with the contribution from the EFTA States provided for by the EEA Financial Mechanism.
      In particular, the Kingdom of Norway shall ensure that the application procedures and implementation modalities are essentially the same for both financial mechanisms referred to in the previous paragraph.
      Any relevant changes in the European Union's cohesion policies shall be taken into account, as appropriate.
      Article 8
      The following shall apply to the implementation of the Norwegian Financial Mechanism:

                  1.

                  The highest degree of transparency, accountability and cost efficiency shall be applied in all implementation phases, as well as objectives and principles of good governance, sustainable development and gender equality. The objectives of the Norwegian Financial Mechanism shall be pursued in the framework of close co-operation between the Beneficiary States and the Kingdom of Norway.

                  2.

                  In order to ensure efficient and targeted implementation, and taking into account national priorities, the Kingdom of Norway shall conclude with each Beneficiary State a Memorandum of Understanding that shall set out the multi-annual programming framework and the structures for management and control.

                  3.

                  After having concluded the Memorandum of Understanding, the Beneficiary States shall submit programme proposals. The Kingdom of Norway will appraise and approve the proposals and conclude grant agreements with the Beneficiary States for each programme. The level of detail in the programme shall take into account the size of the contribution. Within programmes, projects may in exceptional cases be specified, including conditions for their selection, approval and control, in accordance with the provisions for implementation referred to in paragraph 8.
                  The implementation of the agreed programmes shall be the responsibility of the Beneficiary States. The Beneficiary States shall provide for an appropriate management and control system in order to ensure a sound implementation and management system. The Beneficiary State and the Kingdom of Norway may agree, in specific circumstances, that programmes be operated by any entity appointed by them.

                  4.

                  Partnerships shall, where appropriate, be applied in the preparation, implementation, monitoring and evaluation of the financial contributions in order to ensure broad participation. Partners may include, inter alia, local, regional and national levels, as well as the private sector, civil society and social partners in the Beneficiary States and the Kingdom of Norway.

                  5.

                  The control system provided for the management of the Norwegian Financial Mechanism shall ensure the respect of the principle of sound financial management. The Kingdom of Norway may carry out controls according to internal requirements. The Beneficiary States shall provide all necessary assistance, information and documentation to this effect. The Kingdom of Norway may suspend financing and require recovery of funds in the case of irregularities.

                  6.

                  Any project under the multi-annual programming framework in the Beneficiary States may be implemented in cooperation between entities based in the Beneficiary States and in the Kingdom of Norway and in accordance with the applicable rules on public procurement.

                  7.

                  The management costs of the Kingdom of Norway shall be covered by the overall amount referred to in Article 2 and will be specified in the provisions for the implementation referred to in paragraph 8.

                  8.

                  The Kingdom of Norway, or an entity appointed by it, shall be responsible for the overall management of the Norwegian Financial Mechanism. Further provisions for the implementation of the Norwegian Financial Mechanism will be issued by the Kingdom of Norway after consultation with the Beneficiary States. The Kingdom of Norway shall endeavour to issue these provisions before the signing of the Memoranda of Understanding.

            Article 9
      This Agreement shall be ratified or approved by the Parties in accordance with their own procedures. The instruments of ratification or approval shall be deposited with the General Secretariat of the Council of the European Union.
      It shall enter into force on the first day of the second month after the last instrument of ratification or approval has been deposited.
      Pending the completion of the procedures referred to in paragraphs 1 and 2, this Agreement shall be applied on a provisional basis as from the first day of the first month following the deposit of the last notification to this effect.
      Article 10
      This Agreement, drawn up in a single original in the Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Italian, Latvian, Lithuanian, Hungarian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish and Norwegian languages, the text in each of these languages being equally authentic, shall be deposited with the General Secretariat of the Council of the European Union, which will remit a certified copy to each of the Parties to this Agreement.

         Съставено в Брюксел на двадесет и осми юли две хиляди и десета година.
         Hecho en Bruselas, el veintiocho de julio de dos mil diez.
         V Bruselu dne 28. července 2010.
         Udfærdiget i Bruxelles, den 28. juli 2010.
         Geschehen zu Brüssel am 28. Juli 2010.
         Brüsselis kahe tuhande kümnenda aasta juulikuu kahekümne kaheksandal päeval
         Έγινε στις Βρυξέλλες, στις 28 Iουλίου 2010.
         Done at Brussels on the twenty-eighth day of July in the year two thousand and ten.
         Fait à Bruxelles, le vingt-huit juillet deux mil dix.
         Fatto a Bruxelles, addì ventotto luglio duemiladieci.
         Briselē, 2010. gada 28. jūlijā
         Priimta Briuselyje 2010 m. liepos 28 d.
         Kelt Brüsszelben, a kétezer-tizedik év július havának huszonnyolcadik napján.
         Magħmul fi Brussell, it-28 ta’ Lulju 2010.
         Gedaan te Brussel, 28 juli 2010.
         Sporządzono w Brukseli dnia 28 lipca 2010 r.
         Feito em Bruxelas, em vinte e oito de Julho de dois mil e dez.
         Întocmit la Bruxelles, 28 iulie 2010.
         V Bruseli dvadsiateho ôsmeho júla dvetisícdesať.
         V Bruslju, 28. julija 2010
         Tehty Brysselissä kahdentenakymmenentenäkahdeksantena päivänä heinäkuuta vuonna kaksituhattakymmenen.
         Som skedde i Bryssel den tjugoåttonde juli tjugohundratio.
         Utferdiget i Brussel, den 28. juli 2010.

            За Европейския съюз
            Por la Unión Europea
            Za Evropskou unii
            For Den Europæiske Union
            Für die Europäische Union
            Euroopa Liidu nimel
            Για την Ευρωπαϊκή Ένωση
            For the European Union
            Pour l'Union européenne
            Per l'Unione europea
            Eiropas Savienības vārdā –
            Europos Sąjungos vardu
            Az Európai Unió részéről
            Għall-Unjoni Ewropea
            Voor de Europese Unie
            W imieniu Unii Europejskiej
            Pela União Europeia
            Pentru Uniunea Europeană
            Za Európsku úniu
            Za Evropsko unijo
            Euroopan unionin puolesta
            För Europeiska unionen

            For Konveriket Norge

      ADDITIONAL PROTOCOL
      to the Agreement between the European Economic Community and the Republic of Iceland
      THE EUROPEAN UNION
      and
      ICELAND
      HAVING REGARD to the Agreement between the European Economic Community and the Republic of Iceland signed on 22 July 1972, and to the existing arrangements for trade in fish and fishery products between Iceland and the Community,
      HAVING REGARD to the Additional Protocol to the Agreement between the European Economic Community and the Republic of Iceland consequent on the accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic to the European Union, and in particular Article 2 thereof,
      HAVING REGARD to the Additional Protocol to the Agreement between the European Economic Community and Iceland consequent on the accession of the Republic of Bulgaria and Romania to the European Union, and in particular Article 2 thereof,
      HAVE DECIDED TO CONCLUDE THIS PROTOCOL:
      Article 1
      The special provisions applicable to imports into the European Union of certain fish and fishery products originating in Iceland are laid down in this Protocol and the Annex thereto.
      The annual duty free tariff quotas are provided for in the Annex to this Protocol. These tariff quotas shall cover the period from 1 May 2009 to 30 April 2014. The quota levels shall be reviewed by the end of that period taking into account all relevant interests.
      Article 2
      The volumes of the duty free tariff quotas for the first 12 month period 1 May 2009 to 30 April 2010 will be allocated to the period 1 May 2010 to 30 April 2011.
      Should the volumes of the tariff quotas for the tariff quota period from 1 May 2010 to 30 April 2011 not be fully exhausted, the remaining volumes shall be carried over to the tariff quota period from 1 May 2011 to 30 April 2012. For this purpose drawings on the tariff quotas applicable from 1 May 2010 to 30 April 2011 shall be stopped on the second working day in the Commission following 1 September 2011. On the following working day, the unused balances of these tariff quotas shall be made available under the corresponding tariff quota applicable from 1 May 2011 to 30 April 2012. From that date onwards no retroactive drawings and no returns shall be possible on the particular tariff quotas applicable from 1 May 2010 to 30 April 2011.
      Article 3
      This Protocol shall be ratified or approved by the Contracting Parties in accordance with their own procedures. The instruments of ratification or approval shall be deposited with the General Secretariat of the Council of the European Union.
      It shall enter into force on the first day of the second month after the last instrument of ratification or approval has been deposited.
      Pending the completion of the procedures referred to in paragraphs 1 and 2, this Protocol shall be applied on a provisional basis as from the first day of the third month following the deposit of the last notification to this effect.
      Article 4
      This Protocol, drawn up in a single original in the Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Italian, Latvian, Lithuanian, Hungarian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish and Icelandic languages, the text in each of these languages being equally authentic, shall be deposited with the General Secretariat of the Council of the European Union, which will remit a certified copy to each of the Parties to this Agreement.

         Съставено в Брюксел на двадесет и осми юли две хиляди и десета година.
         Hecho en Bruselas, el veintiocho de julio de dos mil diez.
         V Bruselu dne 28. července 2010.
         Udfærdiget i Bruxelles, den 28. juli 2010.
         Geschehen zu Brüssel am 28. Juli 2010.
         Brüsselis kahe tuhande kümnenda aasta juulikuu kahekümne kaheksandal päeval
         'Εγινε στις Βρυξέλλες, στις 28 Iουλίου 2010.
         Done at Brussels on the twenty-eighth day of July in the year two thousand and ten.
         Fait à Bruxelles, le vingt-huit juillet deux mil dix.
         Fatto a Bruxelles, addì ventotto luglio duemiladieci.
         Briselē, 2010. gada 28. jūlijā
         Priimta Briuselyje 2010 m. liepos 28 d.
         Kelt Brüsszelben, a kétezer-tizedik év július havának huszonnyolcadik napján.
         Magħmul fi Brussell, it-28 ta’ Lulju 2010.
         Gedaan te Brussel, 28 juli 2010.
         Sporządzono w Brukseli dnia 28 lipca 2010 r.
         Feito em Bruxelas, em vinte e oito de Julho de dois mil e dez.
         Întocmit la Bruxelles, 28 iulie 2010.
         V Bruseli dvadsiateho ôsmeho júla dvetisícdesať.
         V Bruslju, 28. julija 2010
         Tehty Brysselissä kahdentenakymmenentenäkahdeksantena päivänä heinäkuuta vuonna kaksituhattakymmenen.
         Som skedde i Bryssel den tjugoåttonde juli tjugohundratio.
         Gert i Brussel, 28. juli 2010.

            За Европейския съюз
            Por la Unión Europea
            Za Evropskou unii
            For Den Europæiske Union
            Für die Europäische Union
            Euroopa Liidu nimel
            Για την Ευρωπαϊκή Ένωση
            For the European Union
            Pour l'Union européenne
            Per l'Unione europea
            Eiropas Savienības vārdā –
            Europos Sąjungos vardu
            Az Európai Unió részéről
            Għall-Unjoni Ewropea
            Voor de Europese Unie
            W imieniu Unii Europejskiej
            Pela União Europeia
            Pentru Uniunea Europeană
            Za Európsku úniu
            Za Evropsko unijo
            Euroopan unionin puolesta
            För Europeiska unionen

            Fyrir Ísland

         ANNEX

            SPECIAL PROVISIONS REFERRED TO IN ARTICLE 1 OF THE PROTOCOL

         The Union shall open the following annual duty free tariff quotas for products originating in Iceland, in addition to existing tariff quotas:

                     CN code

                     Description of products

                     Annual (1.5-30.4) tariff quota volume in net weight, unless otherwise specified

                     0303 51 00

                     Herrings of the species Clupea harengus and Clupea pallasii, frozen, excluding livers and roes (1),

                     950 tonnes

                     0306 19 30

                     Frozen Norway lobsters (Nephrops norvegicus)

                     520 tonnes

                     0304 19 35

                     Fillets of redfish (Sebastes spp.), fresh or chilled

                     750 tonnes

            (1)  The benefit of the tariff quota shall not be granted to goods declared for release for free circulation during the period 15 February to 15 June.

      ADDITIONAL PROTOCOL
      to the Agreement between the European Economic Community and the Kingdom of Norway
      THE EUROPEAN UNION
      and
      THE KINGDOM OF NORWAY
      HAVING REGARD to the Agreement between the European Economic Community and the Kingdom of Norway signed on 14 May 1973 and to the existing arrangements for trade in fish and fishery products between Norway and the European Union,
      HAVING REGARD to the Additional Protocol to the Agreement between the European Economic Community and the Kingdom of Norway consequent on the accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Hungary, the Republic of Latvia, the Republic of Lithuania, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic to the European Union, and in particular Article 2 thereof,
      HAVING REGARD to the Additional Protocol to the Agreement between the European Economic Community and the Kingdom of Norway consequent on the accession of the Republic of Bulgaria and Romania to the European Union, and in particular Article 2 thereof,
      HAVE DECIDED TO CONCLUDE THIS PROTOCOL:
      Article 1
      The special provisions applicable to imports into the European Union of certain fish and fishery products originating in Norway are laid down in this Protocol and the Annex thereto.
      The annual duty free tariff quotas are provided for in the Annex to this Protocol. These tariff quotas shall cover the period from 1 May 2009 to 30 April 2014. The quota levels shall be reviewed by the end of that period taking into account all relevant interests.
      Article 2
      The tariff quota levels that should have been opened for Norway as from 1 May 2009 until the implementation of this Protocol shall be divided in equal parts and allocated on a yearly basis for the remaining part of the period of application of this Protocol.
      Article 3
      Norway shall take the necessary steps to ensure the continuation of the regulation laid down by Royal Decree of 21 April 2006 allowing for free transit of fish and fishery products landed in Norway from vessels flying the flag of a Member State of the European Union. This regulation shall apply for the period referred to in Article 1 once the annual tariff quotas have been implemented.
      Article 4
      The rules of origin applicable for the tariff quotas listed in the Annex to this Protocol shall be those set out in Protocol 3 to the Agreement between the European Economic Community and the Kingdom of Norway signed on 14 May 1973.
      Article 5
      This Protocol shall be ratified or approved by the Parties in accordance with their own procedures. The instruments of ratification or approval shall be deposited with the General Secretariat of the Council of the European Union.
      It shall enter into force on the first day of the second month after the last instrument of ratification or approval has been deposited.
      Pending the completion of the procedures referred to in paragraphs 1 and 2, this Protocol shall be applied on a provisional basis as from the first day of the third month following. the deposit of the last notification to this effect.
      Article 6
      This Protocol, drawn up in a single original in the Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Italian, Latvian, Lithuanian, Hungarian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish and Norwegian languages, the text in each of these languages being equally authentic, shall be deposited with the General Secretariat of the Council of the European Union, which will remit a certified copy to each of the Parties.

         Съставено в Брюксел на двадесет и осми юли две хиляди и десета година.
         Hecho en Bruselas, el veintiocho de julio de dos mil diez.
         V Bruselu dne 28. července 2010.
         Udfærdiget i Bruxelles, den 28. juli 2010.
         Geschehen zu Brüssel am 28. Juli 2010.
         Brüsselis kahe tuhande kümnenda aasta juulikuu kahekümne kaheksandal päeval
         Έγινε στις Βρυξέλλες, στις 28 Iουλίου 2010.
         Done at Brussels, on the twenty-eighth day of July in the year two thousand and ten.
         Fait à Bruxelles, le vingt-huit juillet deux mil dix.
         Fatto a Bruxelles, addì ventotto luglio duemiladieci.
         Briselē, 2010. gada 28. jūlijā
         Priimta Briuselyje, 2010 m. liepos 28 d.
         Kelt Brüsszelben, a kétezer-tizedik év július havának huszonnyolcadik napján.
         Magħmul fi Brussell, it-28 ta’ Lulju 2010.
         Gedaan te Brussel, 28 juli 2010.
         Sporządzono w Brukseli dnia 28 lipca 2010 r.
         Feito em Bruxelas, em vinte e oito de Julho de dois mil e dez.
         Întocmit la Bruxelles, 28 iulie 2010.
         V Bruseli dvadsiateho ôsmeho júla dvetisícdesať.
         V Bruslju, 28. julija 2010.
         Tehty Brysselissä kahdentenakymmenentenäkahdeksantena päivänä, heinäkuuta vuonna kaksituhattakymmenen.
         Som skedde i Bryssel den tjugoåttonde juli tjugohundratio.
         Utferdiget i Brussel, 28. juli 2010.

            За Европейския съюз
            Por la Unión Europea
            Za Evropskou unii
            For Den Europæiske Union
            Für die Europäische Union
            Euroopa Liidu nimel
            Για την Ευρωπαϊκή Ένωση
            For the European Union
            Pour l'Union européenne
            Per l'Unione europea
            Eiropas Savienības vārdā –
            Europos Sajungos vardu
            Az Európai Unió részéről
            Għall-Unjoni Ewropea
            Voor de Europese Unie
            W imieniu Unii Europejskiej
            Pela União Europeia
            Pentru Uniunea Europeană
            Za Európsku úniu
            Za Evropsko unijo
            Euroopan unionin puolesta
            För Europeiska unionen

            For Kongeriket Norge

         ANNEX

            SPECIAL PROVISIONS REFERRED TO IN ARTICLE 1 OF THE PROTOCOL

         In addition to the existing duty free tariff quotas, the European Union shall open the following annual duty free tariff quotas for products originating in Norway:

                     CN code

                     Description of products

                     Annual (1.5-30.4) tariff quota volume in net weight unless otherwise specified

                     0303 29 00

                     Other frozen salmonidae

                     2 000 tonnes

                     0303 51 00

                     Herrings of the species Clupea harengus and Clupea pallasii, frozen, excluding livers and roes (1)

                     45 800 tonnes

                     0303 74 30

                     Mackerel of the species Scomber scombrus and Scomber japonicus, frozen, whole, excluding livers and roes (2)

                     39 800 tonnes

                     0303 79 98

                     Other fish, frozen, excluding livers and roes

                     2 200 tonnes

                     0304 29 75
                     ex 0304 99 23

                     Frozen filets of herring of the species Clupea harengus and Clupea pallasii

                     Frozen flaps of herring of the species Clupea harengus and Clupea pallasii (butterflies) (3)

                     67 600 tonnes

                     ex 1605 20 10
                     ex 1605 20 91
                     ex 1605 20 99

                     Shrimps and prawns, peeled and frozen, prepared or preserved

                     7 000 tonnes

                     ex 1604 12 91
                     ex 1604 12 99

                     Herring, spiced and/or vinegar cured, in brine (4)

                     3 000 tonnes net drained weight

            (1)  The benefit of the tariff quota shall not be granted to goods declared for release for free circulation during the period 15 February to 15 June.

            (2)  The benefit of the tariff quota shall not be granted to goods declared for release for free circulation during the period 15 February to 15 June.

            (3)  The benefit of the tariff quota shall not be granted to goods of CN code 0304 99 23 declared for release for free circulation during the period 15 February to 15 June.

            (4)  This tariff quota shall be increased to 4 000 tonnes net drained weight in the period 1 May 2010 to 30 April 2011, to 5 000 tonnes net drained weight in the period 1 May 2011 to 30 April 2012, and to 6 000 tonnes net drained weight in the period 1 May to 30 April in each subsequent 12 month period.


title: 2012/622/EU: Decision of the European Parliament of 10 May 2012 on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2010#Resolution of the European Parliament of 10 May 2012 with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2010

text:
               17.10.2012

               EN

               Official Journal of the European Union

               L 286/377

         DECISION OF THE EUROPEAN PARLIAMENT
   of 10 May 2012
   on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2010
   (2012/622/EU)
   THE EUROPEAN PARLIAMENT,

               —

               having regard to the final annual accounts of the European Medicines Agency for the financial year 2010,

               —

               having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2010, together with the Agency’s replies (1),

               —

               having regard to the Council’s recommendation of 21 February 2012 (06083/2012 – C7-0051/2012),

               —

               having regard to Article 319 of the Treaty on the Functioning of the European Union,

               —

               having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

               —

               having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council (3) establishing a European Medicines Agency, and in particular Article 68 thereof,

               —

               having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (4), and in particular Article 94 thereof,

               —

               having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

               —

               having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0107/2012),

               1.

               Postpones its decision on granting the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2010;

               2.

               Sets out its observations in the resolution below;

               3.

               Instructs its President to forward this Decision and the resolution that forms an integral part of it to the Executive Director of the European Medicines Agency, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series).

            The President

         Martin SCHULZ

            The Secretary-General

         Klaus WELLE

      (1)  OJ C 366, 15.12.2011, p. 27.

      (2)  OJ L 248, 16.9.2002, p. 1.

      (3)  OJ L 136, 30.4.2004, p. 1.

      (4)  OJ L 357, 31.12.2002, p. 72.

      RESOLUTION OF THE EUROPEAN PARLIAMENT
      of 10 May 2012
      with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2010
      THE EUROPEAN PARLIAMENT,

                  —

                  having regard to the final annual accounts of the European Medicines Agency for the financial year 2010,

                  —

                  having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2010, together with the Agency’s replies (1),

                  —

                  having regard to the Council’s recommendation of 21 February 2012 (06083/2012 – C7-0051/2012),

                  —

                  having regard to Article 319 of the Treaty on the Functioning of the European Union,

                  —

                  having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

                  —

                  having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council (3) establishing a European Medicines Agency, and in particular Article 68 thereof,

                  —

                  having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (4), and in particular Article 94 thereof,

                  —

                  having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

                  —

                  having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0107/2012),

                  A.

                  whereas the Court of Auditors, in its report on the annual accounts of the European Medicines Agency for the financial year 2009, qualified its opinion on the legality and regularity of the underlying transactions,

                  B.

                  whereas in its Decision of 10 May 2011, Parliament decided to postpone its decision on granting the Executive Director of the Agency discharge in respect of the implementation of its budget for 2009 (5) but then granted it in its Decision of 25 October 2011 (6),

                  C.

                  whereas on 25 October 2011 Parliament granted the Executive Director of the Agency discharge for implementation of the Agency’s budget for the financial year 2009, and in its resolution accompanying the discharge decision, inter alia:

                              —

                              emphasises that the discharge authority should continue to carefully monitor during the upcoming discharge procedures the level of implementation of the measures undertaken to address the Agency’s serious weaknesses disclosed by the reports from both the Court of Auditors and the Internal Audit Service (IAS),

                              —

                              called on the Agency to inform the discharge authority of the action taken on issues relating to effective compliance with its Code of Conduct as regards the management of conflicts of interest,

                              —

                              insisted, but also warned the Agency, that all the action mentioned in the respective audit reports, including the one for the year 2010, should be fully implemented before the start of the next discharge procedure,

                  D.

                  whereas the Court of Auditors has stated that it has obtained reasonable assurances that the annual accounts for the financial year 2010 are reliable and that the underlying transactions are legal and regular,

                  E.

                  whereas the budget of the Agency for 2010 was EUR 208 400 000, which represents an increase of 7,20 % over the financial year 2009;

                  F.

                  whereas the initial contribution of the Union to the budget of the Agency for 2010 was EUR 28 279 600 compared with EUR 36 390 000 in 2009 (7), and whereas the overall contribution of the Union to the budget of the Agency for 2010 was EUR 36 600 100,

         Follow-up of 2009 discharge

                  1.

                  Expects the Agency to inform the discharge authority of the results of the action taken with regard to the following issues:

                              —

                              the process of adoption by the Management Board of the action plan with specific measures and a timetable for implementation to remedy the shortcomings identified in the procurement procedures;

                              —

                              the thorough verification of the effective use of the existing procedures for the identification and management of conflicts of interest for its staff and experts;

                        calls on the Court of Auditors to give reasonable assurances that the Agency has effectively addressed its shortcomings relating to procurement procedures, and on the IAS to give assurances the discharge authority on the effective use of existing procedures for the management of conflicts of interest for the Agency’s staff and experts;

                  2.

                  Calls on the Agency and on the IAS to immediately verify whether all the action specified in the audit reports, including that for 2010, were fully implemented and to inform the discharge authority accordingly;

                  3.

                  Notes from the Agency that on 15 December 2011 the Management Board endorsed a proposal for the Agency to present at the June 2012 meeting of the Management Board the detailed implementing measures related to the:

                              —

                              establishment of the new structure and scope of the Advisory Committee on Procurement and Contract,

                              —

                              implementation of a multiannual procurement plan,

                              —

                              establishment of the responsibilities for the above;

                        insists that the Management Board sends the Action Plan to the discharge authority at the latest by 30 June 2012;

         Budget and financial management

                  4.

                  Recalls that the initial Union contribution to the Agency for 2010 amounted to EUR 26 335 100; notes however that EUR 10 265 000 coming from the recovery of surplus, was added to that amount which, as a result, makes a total Union contribution of EUR 36 600 100 for 2010;

                  5.

                  Stresses that the general budget of the European Union for the financial year 2010, as definitively adopted, presents two different figures as the initial contribution of the Union to the budget of the Agency, i.e. EUR 28 279 600 and EUR 26 335 100; urges, therefore, the Commission to inform the discharge authority of the exact subsidy allocated to the Agency;

                  6.

                  Acknowledges that the Agency’s budget is financed both from the Union budget and from fees paid by the pharmaceutical industry when applying for, obtaining or maintaining Union marketing authorisations; finds from the Annual Activity Report that in 2010, 73 % of the revenue of the Agency is estimated to have derived from the fee revenue and that, in parallel with the increase in the fee-based revenue, the relative percentage income from the Union contribution fell from 23 % in 2006 to 14 % in 2010;

                  7.

                  Finds from the Annual Activity Report that 17 exceptions were entered in the register of exceptions in 2010;

                  8.

                  Notes weaknesses in the Agency’s system for validating creditor claims in respect of IT contractors; takes note of the Agency’s statement that the weaknesses noted by the Court of Auditors related to a human error and were corrected, that it has strengthened its ex-ante operational and financial control of invoices and that no further weaknesses have been detected; invites the Court of Auditors to verify and inform Parliament in this respect;

         Carryover appropriations and cancellations

                  9.

                  Acknowledges from the Agency’s Report on budgetary and financial management that automatic carryovers to the 2011 financial year totalled EUR 41 655 049,44, or 20,90 % of the appropriation committed, and that one non-automatic carryover to the 2011 financial year was requested totalling EUR 3 500 000, or 1,68 % of the final appropriation;

                  10.

                  Is concerned that the Court of Auditors has once more reported a high carryover of EUR 17 600 000 in Title II (Administrative expenditure); stresses that this situation indicates delays in the implementation of activities financed from Title II of the Agency’s budget and that the Agency is not complying with the budgetary principle of annuality;

                  11.

                  Notes with concern the additional comment from the Court of Auditors that only 36 % of the appropriations carried forward to 2011 correspond to expenditure accrued from 2010, while the remaining 64 % of amounts carried over did not relate to the 2010 financial year;

                  12.

                  Points out that the Court of Auditors had already reported a high level of carryovers in previous financial years; notes, in particular, that in the 2009 budget the Court of Auditors reported a carryover of EUR 19 500 000 (38 % of the Agency’s commitments) and in 2008 it was EUR 36 000 000 (19,7 % of the 2008 budget);

                  13.

                  Establishes from the Agency’s Report on budgetary and financial management that in 2010, appropriations totalling EUR 9 074 296,49 were cancelled compared with EUR 7 693 276,58 in 2009; notes the Agency’s reply that the level of cancelled expenditure appropriations is a result of stringent monitoring of actual revenue and adjustments to expenditure; urges the Agency to take immediate action to reduce the level of cancelled appropriations and to adopt an Action Plan with concrete measures — including aimed at a stricter estimation of the fee income and the period to be received — and deadlines to address this persistent problem by 30 June 2012;

         Procurement Procedures and Transfers

                  14.

                  Ascertains from the Annual Activity Report that, in addition to the 165 specific contracts concluded under framework contracts, 70 new procurement contracts exceeding EUR 25 000 in value were concluded by the Agency during 2010;

                  15.

                  Notes from the Agency’s Report on budgetary and financial management that, during 2010, 13 transfers of a total amount of EUR 13 714 500 (15,29 % of the final appropriations) were approved; further notes that the Agency already adopted 10 transfers of a total amount of EUR 9 609 000 in 2009; calls on the Agency to adopt an Action Plan with concrete measures and deadlines to remedy this persistent problem;

         System of remuneration for services

                  16.

                  Urges the Agency to introduce a system of remuneration for services provided by national Member State authorities based on the Member States’ real costs; also calls on the Agency to promptly inform the discharge authority when this system is put in place; notes in this regards that a new payment system was already presented to the Management Board at their meeting of 10 December 2009 but it, in the end, rejected the proposal;

                  17.

                  Supports all efforts at the executive and administrative levels of the Agency to reform the payment system for services provided by Member States’ authorities which should clearly be based on the real costs; urges the Management Board to move forward on this issue;

                  18.

                  Notes that by refusing a new payment system, the Management Board accepts and takes direct responsibility for very important risks, such as non-compliance with legislative requirements, the potential financial impact of the current remuneration system, and reputation; is therefore not ready to accept this questionable attitude from the Management Board and calls on the Agency to adopt an Action Plan on this matter and to inform the discharge authority by 30 June 2012;

         Human resources management

                  19.

                  Urges the Agency to strengthen its recruitment processes and ensure that its documentation is correctly managed; calls in particular on the Agency to improve the documentation of the recruitment files for contract agents and on the Appointing Authority to adopt the reserve lists proposed by the selection committees;

                  20.

                  Acknowledges also from the Court of Auditors that the Agency did not distinguish sufficiently between employment-agency staff and contract staff recruitment; calls therefore on the Agency to use employment-agency staff to cover short-term needs only and grant transparent access for contract staff positions;

         Management of conflict of interest

                  21.

                  Urges the Agency to provide central coordination for the development of a common experts’ assessment methodology applicable to all national competent authorities and for its monitoring; notes that, after the Memorandum of Understanding (MoU) signed between the Agency and each national competent authority on the monitoring of the scientific level of the experts became effective on 4 July 2011, the Agency still has responsibility for developing and coordinating a common experts’ assessment and experts’ methodology;

                  22.

                  Emphasises that the Agency needs to finalise the signing of MoUs on the independence of scientific evaluation, to amend internal procedures correspondingly, and to update the experts’ database; takes note of the Agency’s reply that MoUs on the independence of scientific evaluation have been signed as of October 2011 and that the experts’ database was updated to allow for the direct uploading of the electronic declarations of interest into the database; calls on the Agency to inform the discharge authority of the status of implementation of these measures by 30 June 2012; also invites the IAS to inform the discharge authority when these very important recommendations are effectively implemented by the Agency;

                  23.

                  Calls on the Agency to inform the discharge authority of the way in which it ensures that procedures for the involvement of experts are fully applied until the MoUs on the independence of scientific evaluation have been signed by all national competent authorities;

                  24.

                  Calls on the Agency to report on its involvement in the organisation of conferences by private organisations such as the Organisation for Professionals in Regulatory Affairs;

                  25.

                  Takes note from the Agency of the adoption on 1 February 2012 of the ‘Decision on rules relating to Articles 11a and 13 of the Staff Regulations concerning the handling of declared interests of employees of the European Medicines Agency’ by the Management Board and of the ‘Decision on rules concerning the handling of declared interests of national experts on secondment, visiting experts, trainees and interims of the European Medicines Agency’ by the Executive Director; calls on the Agency to inform the discharge authority of the concrete measures undertaken to implement these decisions by 30 June 2012 in order to enable Parliament to assess the procedures in place for handling potential conflicts of interest for all categories listed in the two decisions, plus the members of the Management Board;

                  26.

                  Notes with concern that in the financial circuits there are also potential conflicts of interests in processing payments due to insufficient segregation of duties; urges the Agency therefore to duly take into account this very significant risk and take immediate action to address this deficiency;

                  27.

                  Notes that the former Executive Director of the Agency wrote to the Agency on 28 December 2010 outlining the activities which he was intending to take up at the end of his term of office; considers the first decision of 11 January 2011, taken by the Chairman of the Agency Management Board, to authorise the new activities of the former Executive Director of the Agency to be a breach of Union rules relating to conflicts of interest, in particular with regard to Title II, Article 16, of the Staff Regulations of the Officials of the European Union; recalls that according to Title II, Article 11, and title IV, Article 91, of the Conditions of Employment of Other Servants of the European Union, this provision applies by analogy to temporary agents and to contract employees; considers the fact that the Management Board adopted limitations on the future activities of the former Executive Director on 17 March 2011 — only after strong public protest — to be clear proof that the Agency did initially not apply the Staff Regulations properly, which in turn raises serious questions about their application of the rules in general; asks the Executive Director to present a detailed report on the implementation of Article 16 of the Staff Regulations within the Agency;

                  28.

                  Is seriously concerned by the failure of the Agency and its Management Board to effectively address the matter of conflict of interests; takes note that in April 2012 the Agency adopted a revised policy on the handling of conflicts of interests of Scientific Committee members and experts, as well as a breach of trust procedure for Committee members and experts; insists that implementation and concrete results are the only elements to prove the efficiency of the new policy and procedure; believes that the Agency should verify, during 2012, all declarations of interest of experts and Scientific Committee members; therefore, calls on the Agency to provide data — figures and names included — following the enforcement of this procedure; calls also on the Agency to have verified at least 75 % of the experts’ declarations of interest and at least 75 % of the Scientific Committee members’ declarations of interest and to provide the discharge authority with the verification results and with an Action Plan with a calendar concerning the rest of the verification process for declarations of interest by the end of August 2012;

                  29.

                  Recalls that, following the employment of the Agency’s former Executive Director by a consultancy that advises, among others, pharmaceutical companies almost immediately after he left the Agency, the discharge authority raised concerns over the actual independence of the Agency and the way in which its Management Board implemented Article 16 of the Staff Regulations; is furthermore concerned by the allegations that the Agency’s former Executive Director created his own consultancy firm while still in office; calls on the Agency to provide the discharge authority with further information on this matter by 30 June 2012;

                  30.

                  Urges the Court of Auditors to finalise and present its current audit of conflict of interest in the Agency;

                  31.

                  Regrets the fact that many of the experts failed to publish their declarations of interests, and that the comparison of declarations of interests published by the relevant national agencies and by the Agency shows significant differences in some cases; deplores, furthermore, the fact that at least one member of the Management Board of the Agency, also substitute member of the Committee for Medicinal Products for Human Use, failed to declare his recent management responsibilities in a pharmaceutical firm;

                  32.

                  Welcomes the Agency’s initiative to publish the declarations of interests of its staff occupying management positions and of the experts involved in the evaluation of medicinal products on its website; notes with interest that the list of experts also indicates their risk level in terms of conflict of interest; believes that at least the previous working places – professional background – should also be published along with the declarations of interest to allow verification of the declarations of interest and identify possible conflicts; therefore invites the Agency to provide Parliament with information on the status of implementation of these measures by 30 June 2012;

                  33.

                  Urges the Agency to carry out checks on the declarations of interests submitted to it, and a detailed check on a random basis, notably by implementing a system under which declarations are cross-checked against information held by industry and by the relevant national agencies;

                  34.

                  Is nevertheless concerned by the Agency’s approach vis-à-vis the scrutiny of declarations of interest, which is primarily based on trust rather than on verification; is notably concerned by the fact that the comparison of the experts’ declaration of interest published by the relevant national agencies and by the Agency reveals significant discrepancies in some cases; therefore calls on the Agency to establish a genuine mechanism enabling proper scrutiny of the declarations of interest received by the Agency and to inform the discharge authority on this matter by 30 June 2012;

                  35.

                  Urges the Agency to apply its conflict of interest policy to its Management Board;

                  36.

                  Notes that the Agency has been audited by the Court of Auditors in the framework of the Special Report on conflicts of interest management in the Union agencies; acknowledges from the Court of Auditors that the above-mentioned Special Report will be published by the end of June 2012; is of the opinion that, given the extent of criticisms questioning conflict of interest issues in the Agency, the decision on discharge should be postponed until the publication of the Special Report to take into account the findings of the Court of Auditors in this respect;

                  37.

                  Considers that the effective management of conflict of interest is crucial to maintain public trust in the work of the Agency;

                  38.

                  Acknowledges the Agency’s willingness to publish the Declarations of Interests of experts involved in the evaluation of medicinal products; but deplores the fact that many of the experts have yet to publish their Declarations of Interests;

                  39.

                  Takes note of the fact that the Management Board adopted limitations on the subsequent professional activities of the former Executive Director on 17 March 2011 after public protest supported by Parliament regarding its decision in January 2011 to authorise his new activities fully; recalls in this context that a delegation of the Committee on the Environment, Public Health and Food Safety visited the Agency in June 2011 to follow up this case and to receive further information on the improved procedures; recalls, furthermore, that the Committee held an exchange of views with the Executive Director — designate in July 2011 where the issue was addressed again in order to avoid future recurrences;

         Performance

                  40.

                  Considers the assessment of the adequacy and effectiveness of the systems in place to support the provision of scientific advice for human medicines in the Agency as an important tool to measure the Agency’s performance;

                  41.

                  Takes note of the increased number of products and services (opinions, reports, scientific advice, inspections) compared with 2009; is also satisfied with the implementation of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (8) and encourages the Agency to continue its action to provide incentives for research, development and placing on the market of designated orphan medicinal products;

         Internal audit

                  42.

                  Acknowledges from the Agency that 11 ‘very important’ recommendations from the IAS still need to be implemented; notes that one of them has been reported as implemented by the Agency and is now under the IAS review;

                  43.

                  Is concerned that seven of these ‘very important’ recommendations have been delayed by up to more than 12 months; notes that these recommendations concern:

                              —

                              the compliance with Article 110 of the Staff Regulations;

                              —

                              the recruitment process;

                              —

                              the use of databases;

                              —

                              the definition of rules on filing for products;

                              —

                              the guidelines on the management of potential conflicts of interest of staff;

                              —

                              the procedures on involvement of experts;

                              —

                              the segregation of duties in the financial circuits;

                        urges the Agency therefore to promptly address these deficiencies identified by the IAS and to inform the discharge authority of the measures taken;

                  44.

                  Is further concerned that the Agency rejected two ‘very important’ recommendations relating to:

                              —

                              the fees paid to national agencies;

                              —

                              the reduction in the number of consultants working in-house;

                        urges the Agency to explain immediately to the discharge authority the rejection of these two recommendations;

                  45.

                  Notes that if the IAS in its follow-up report of September 2010 continues to find ‘inadequate assessment of the independence of the experts’, the Executive Director should publish a list of all the authorised medicinal products concerned and report how the Agency intends to rectify these procedures;

                  46.

                  Draws attention to its recommendations from previous discharge reports, as set out in the Annex to this resolution;

                  47.

                  Refers, in respect of the other observations accompanying its Decision on discharge, which are of a horizontal nature, to its resolution of 10 May 2012 (9) on the performance, financial management and control of the agencies.

         (1)  OJ C 366, 15.12.2011, p. 27.

         (2)  OJ L 248, 16.9.2002, p. 1.

         (3)  OJ L 136, 30.4.2004, p. 1.

         (4)  OJ L 357, 31.12.2002, p. 72.

         (5)  OJ L 250, 27.9.2011, p. 173.

         (6)  OJ L 313, 26.11.2011, p. 27.

         (7)  OJ L 64, 12.3.2010, p. 445.

         (8)  OJ L 18, 22.1.2000, p. 1.

         (9)  Texts adopted, P7_TA(2012)0164. (see page 388 of this Official Journal).

      ANNEX

         EUROPEAN PARLIAMENT RECOMMENDATIONS OVER PAST YEARS

                  European Medicines Agency

                  2006

                  2007

                  2008

                  2009

                  Performance

                  n.a.

                              —

                              The principle of sound financial management was not rigorously fulfilled: the Agency’s cash forecast had not been prepared properly

                              —

                              The Agency carries out its operations in two locations, exposing it to additional costs (direct posts: EUR 450 000)

                              —

                              Good results in having put in place sophisticated activity-based budgeting and user-satisfaction monitoring

                              —

                              Calls on the Agency to reassess its brokerage policy in light of the financial risks incurred throughout the year

                              —

                              The Agency carries out its operations in two locations, exposing it to additional costs

                              —

                              Unacceptable that the Agency does not apply the relevant rules for management of conflicts of interest effectively

                              —

                              12 very important & 1 critical recommendations from several earlier IAS Annual Audit Reports were still not implemented in 2009
                              Unacceptable that the Agency is not complying with its Code of Conduct, urges the Agency to document & assess its controls & file the relevant allocation decisions which must be made available on its website

                              —

                              Urges the Agency to inform the discharge authority of the steps it has taken to ensure the independence of its experts since its inception

                              —

                              Asks the Agency to complete & regularly update the European Experts Database as required by Regulation (EC) No 726/2004

                  Carry-over of appropriations

                  The budgetary principle of annuality was not strictly observed: the utilisation rate for commitment appropriations was less than 60 %. more than 40 % of the commitments were carried over to the financial year 2007

                  The agency had difficulties in the programming, the budgeting of its activities, and their implementation: EUR 32 000 000 euro were carried over and EUR 4 000 000 were cancelled: Calls on the agency to fulfil the principle of annuality

                  Calls on the Agency to fulfil the annuality principle: the budget appropriations carried over and cancelled have amounted respectively to EUR 36 000 000 (19,7 % of the budget) and EUR 9 700 000 (5,3 % of the budget)

                  Court of Auditors reports a carryover of EUR 19 500 000 (38 % of Agency’s commitments), EUR 14 800 000 of this was for activities not yet implemented at year end, indicates delays in the implementation of activities financed form Title II. Agency is not in accordance with budgetary principle of annuality

                  Procurement procedures

                  n.a.

                              —

                              Transparency issues at the level of selection criteria and at the level of the evaluation methods for the price criteria and joint procurement procedure

                              —

                              Recalls on improving procurement management

                  Calls on the Agency to improve the quality of its procurement procedures so as to put an end to the shortcomings: i.e. as regards the application of evaluation methods for the price criteria and as regards the essential need for justifications for the choice procedure

                              —

                              Concerned that the Court of Auditors findings of errors in the procurement procedures corresponding to a significant amount of the Agency’s total budget for the financial year of 2009. Shortcomings in evaluation criteria such as price and choice of procedures

                              —

                              Urges the Agency to improve the quality of its procurement procedures in order to put an end to the shortcomings identified by the Court of Auditors

                              —

                              Calls on the Agency to set up a multiannual procurement plan

                              —

                              Calls on the Agency to ensure the results of procurement procedures are verified before contracts are awarded

                  Revenue from fees

                  The Agency has not been able to make a comprehensive analysis of the costs incurred by Member States’ rapporteurs in order to obtain an objective and documented basis on which to adapt its payments to them, and consequently the fee charged to its customers: This situation was in breach of the Fee Regulation

                  Transparency issues on the amount repaid to the Member States’ rapporteurs

                  Calls on the Commission to evaluate the Agency’s endemic high level of cash holdings (EUR 41 887 000)

                  Calls on the Agency to ensure better coordination between its financial & scientific services in order to remedy the unacceptable long day of recovery orders

                  Internal Audit

                  n.a.

                  n.a

                  Calls on the Agency to fulfil a ‘critical recommendation’ made the Commission’s Internal Audit Service related to the area of experts’ conflicts of interests, and other eight ‘very important’ recommendations in the areas of documentation of conflicts of interest for the Agency’s staff, databases used to support the administrative procedures for evaluation and development of guidelines for filing and full implementation of such guidelines

                              Unacceptable that the Executive Director’s statement of assurance does not mention any reservations which is inconsistent with the undertaking given in its Code of Conduct adopted by the Agency in the light of the statements of assurance from the IAS & the Court of Auditors

                              Asks the Agency to forward the IAS reports since 2007 to the discharge authority by 30 June 2011

                              Urges the Agency to rapidly implement the IAS recommendations, provide the discharge authority with an overview of measures taken & implemented