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Regulation (EU) 2016/793 of the European Parliament and of the CouncilShow full title

Regulation (EU) 2016/793 of the European Parliament and of the Council of 11 May 2016 to avoid trade diversion into the European Union of certain key medicines (codification)

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  1. Introductory Text

  2. Article 1.(1) This Regulation lays down: (a) the criteria for establishing...

  3. Article 2.(1) The importation into the Union of tiered-priced products for...

  4. Article 3.The tiered price referred to in Article 4(2)(b) shall, at...

  5. Article 4.(1) In order for products to benefit from this Regulation,...

  6. Article 5.(1) The power to adopt delegated acts is conferred on...

  7. Article 6.(1) Delegated acts adopted under this Article shall enter into...

  8. Article 7.A product approved as a tiered-priced product and listed in...

  9. Article 8.A permanent logo, as set out in Annex V, shall...

  10. Article 9.(1) Where there is reason to suspect that, contrary to...

  11. Article 10.(1) If products suspended for release or detained by customs...

  12. Article 11.This Regulation shall not apply to goods of a non-commercial...

  13. Article 12.(1) The Commission shall monitor on an annual basis the...

  14. Article 13.(1) The application of this Regulation shall in no circumstances...

  15. Article 14.Regulation (EC) No 953/2003 is repealed. References to the repealed...

  16. Article 15.This Regulation shall enter into force on the twentieth day...

  17. Signature

    1. ANNEX I

      LIST OF TIERED-PRICED PRODUCTS

    2. ANNEX II

      COUNTRIES OF DESTINATION

      1. Afghanistan

      2. Angola

      3. Armenia

      4. Azerbaijan

      5. Bangladesh

      6. Benin

      7. Bhutan

      8. Botswana

      9. Burkina Faso

      10. Burundi

      11. Cambodia

      12. Cameroon

      13. Cape Verde

      14. Central African Republic

      15. Chad

      16. China

      17. Comoros

      18. Congo

      19. Côte d'Ivoire

      20. Democratic Republic of the Congo

      21. Djibouti

      22. Equatorial Guinea

      23. Eritrea

      24. Ethiopia

      25. Gambia

      26. Ghana

      27. Guinea

      28. Guinea-Bissau

      29. Haiti

      30. Honduras

      31. India

      32. Indonesia

      33. Kenya

      34. Kiribati

      35. Kyrgyzstan

      36. Laos

      37. Lesotho

      38. Liberia

      39. Madagascar

      40. Malawi

      41. Maldives

      42. Mali

      43. Mauritania

      44. Moldova

      45. Mongolia

      46. Mozambique

      47. Myanmar/Burma

      48. Namibia

      49. Nepal

      50. Nicaragua

      51. Niger

      52. Nigeria

      53. North Korea

      54. Pakistan

      55. Rwanda

      56. Samoa

      57. São Tomé and Príncipe

      58. Senegal

      59. Sierra Leone

      60. Solomon Islands

      61. Somalia

      62. South Africa

      63. Sudan

      64. Swaziland

      65. Tajikistan

      66. Tanzania

      67. Timor-Leste

      68. Togo

      69. Turkmenistan

      70. Tuvalu

      71. Uganda

      72. Vanuatu

      73. Vietnam

      74. Yemen

      75. Zambia

      76. Zimbabwe

    3. ANNEX III

      PERCENTAGES REFERRED TO IN ARTICLE 3

      1. Percentage referred to in Article 3(a): 25 %

      2. Percentage referred to in Article 3(b): 15 %

    4. ANNEX IV

      SCOPE OF DISEASES

      1. HIV/AIDS, malaria, tuberculosis and related opportunistic diseases

    5. ANNEX V

      LOGO

      1. The winged staff of Aesculapius with a coiled serpent, in...

    6. ANNEX VI

      REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS

    7. ANNEX VII

      CORRELATION TABLE

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