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Third National Report on the Implementation of the Cartagena Protocol on Biosafety
(NR3 )
last updated: 03 Sep 2020
General Information
Contact person submitting the report
9. Organizations/stakeholders who were consulted or participated in the preparation of
this report
10. Time period covered by this report
Party to the Cartagena Protocol on Biosafety
11. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
Article 2 – General provisions
14. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?
16. Which specific instruments are in place for the implementation of your national biosafety framework?
One or more national biosafety laws
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
21. Here you may provide further details on the implementation of Article 2 in your country
Article 5 - Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
23. If you answered Yes to question 22, has this information been submitted to the BCH?
24. Here you may provide further details on the implementation of Article 5 in your country:
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
26. Does your country regulate the contained use of LMOs?
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
28. Here you may provide further details on the implementation of Article 6 in your country:
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol OR a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
30. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
31. If you answered Yes to question 30, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
32. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
33. Has your country established legal requirements for the accuracy of information contained in the notification?
34. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
35. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
36. If you answered Yes to question 35, how many LMOs has your country approved to date for import for intentional introduction into the environment?
37. If you answered Yes to question 35, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
38. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
39. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
40. With reference to the decisions taken on intentional transboundary movements of LMOs for intentional introduction into the environment, has your country received a notification from the Party(ies) of export or from the exporter(s) prior to the transboundary movement?
41. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?
42. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?
43. Has your country informed the notifier(s) and the BCH of its decision(s)?
44. What percentage of your country’s decisions fall into the following categories?
45. In cases where your country approved an import with conditions or prohibited an import, did it provide reasons on which its decisions were based to the notifier and the BCH?
46. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
47. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
48. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
49. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
50. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
51. Has your country indicated its needs for financial and technical assistance and capacity-building in respect of LMOs-FFP?
52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
53. How many LMOs-FFP has your country approved to date?
54. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
55. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
56. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
57. Has your country informed the Parties through the BCH of its decision(s) regarding domestic use, including placing on the market, of LMOs-FFP within 15 days?
58. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP
Article 12 – Review of decision
59. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
60. Has your country ever received a request for a review of a decision?
61. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
62. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
63. Has your country informed both the notifier and the BCH of the review and/or changes in the decision?
64. Has your country informed both the notifier and the BCH of the review and changes in the decision within thirty days?
65. Has your country provided reasons to both the notifier and the BCH for the review and/or changes in the decision?
66. Here you may provide further details on the implementation of Article 12 in your country
Article 13 – Simplified procedure
67. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
68. Has your country ever applied the simplified procedure?
69. If you answered Yes to question 68, has your country informed the Parties through the BCH of the cases where the simplified procedure applies?
70. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
71. Here you may provide further details on the implementation of Article 13 in your country
Article 14 – Bilateral, regional and multilateral agreements and arrangements
72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
73. If you answered Yes to question 72, how many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
74. If you answered Yes to question 72, has your country informed the Parties through the BCH of the agreements or arrangements?
75. If you answered Yes to question 72, please provide a brief description of the scope and objective of the agreements or arrangements entered into
76. Here you may provide further details on the implementation of Article 14 in your country
Articles 15 & 16 – Risk Assessment and Risk Management
77. Has your country established a national framework for conducting risk assessments prior to taking decisions regarding LMOs?
78. If you answered Yes to question 77, does this framework include procedures for identifying and/or training national experts to conduct risk assessments?
79 a. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
Risk assessment:
79 b. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
Management / Control:
79 c. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
Monitoring:
80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
81. Is your country using the "ManualonRiskAssessmentofLMOs" (developed by CBD Secretariat) for training in risk assessment?
82. Is your country using the "GuidanceonRiskAssessmentofLMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for training in risk assessment?
83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?
