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Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union (Text with EEA relevance)
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1.The competent authorities referred to in Article 6(1) shall carry out checks to verify whether users comply with their obligations under Articles 4 and 7, taking into account that the implementation by a user of a best practice in relation to access and benefit-sharing, recognised under Article 8(2) of this Regulation or under Article 20(2) of the Nagoya Protocol, may reduce that user’s risk of non-compliance.
2.[F1The Secretary of State] shall ensure that the checks carried out pursuant to paragraph 1 are effective, proportionate, dissuasive and detect cases of user non-compliance with this Regulation.
3.The checks referred to in paragraph 1 shall be conducted:
(a)in accordance with a periodically reviewed plan developed using a risk-based approach;
(b)when a competent authority is in possession of relevant information, including on the basis of substantiated concerns provided by third parties, regarding a user’s non-compliance with this Regulation. Special consideration shall be given to such concerns raised by provider countries.
4.The checks referred to in paragraph 1 of this Article may include an examination of:
(a)the measures taken by a user to exercise due diligence in accordance with Article 4;
(b)documentation and records that demonstrate the exercise of due diligence in accordance with Article 4 in relation to specific use activities;
(c)instances where a user was obliged to make declarations under Article 7.
On-the-spot checks may also be carried out, as appropriate.
5.Users shall offer all assistance necessary to facilitate the performance of the checks referred to in paragraph 1.
6.F2... Where, following the checks referred to in paragraph 1 of this Article, shortcomings have been detected, the competent authority shall issue a notice of remedial action or measures to be taken by the user.
Depending on the nature of the shortcomings, [F3the Secretary of State] may also take immediate interim measures.
Textual Amendments
F1Words in Art. 9(2) substituted (31.12.2020) by The Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018 (S.I. 2018/1393), regs. 1, 3(9)(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 9(6) omitted (31.12.2020) by virtue of The Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018 (S.I. 2018/1393), regs. 1, 3(9)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in Art. 9(6) substituted (31.12.2020) by The Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018 (S.I. 2018/1393), regs. 1, 3(9)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
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