Article 62U.K.Data sharing
1.In order to avoid animal testing, testing on vertebrates for the purposes of this Regulation shall be undertaken only as a last resort. Testing on vertebrates shall not be repeated for the purposes of this Regulation.
2.Any person intending to perform tests or studies (‘the prospective applicant’)
(a)shall, in the case of data involving tests on vertebrates; and
(b)may, in the case of data not involving tests on vertebrates,
submit a written request to the [F1competent authority] to determine whether such tests or studies have already been submitted to the F2... competent authority in connection with a previous application under this Regulation [F3or Regulation (EU) No 528/2012 as it had effect immediately before IP completion day] or Directive 98/8/EC. [F4The competent authority must] verify whether such tests or studies have already been submitted [F5and whether the competent authority has access to the tests or studies].
Where such tests or studies have already been submitted to the F6... competent authority in connection with a previous application, under this Regulation [F7or Regulation (EU) No 528/2012 as it had effect immediately before IP completion day] or Directive 98/8/EC, [F8and where the competent authority has access to the tests or studies the competent authority must], without delay, communicate the name and contact details of the data submitter and data owner to the prospective applicant.
The data submitter shall, where relevant, facilitate contacts between the prospective applicant and the data owner.
Where the data acquired under those tests or studies are still protected under Article 60, the prospective applicant:
(a)shall, in the case of data involving tests on vertebrates; and
(b)may, in the case of data not involving tests on vertebrates,
request from the data owner all the scientific and technical data related to the tests and studies concerned as well as the right to refer to these data when submitting applications under this Regulation.
Textual Amendments
F1Words in Art. 62(2) substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 108(a)(i) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 30)
F2Words in Art. 62(2) omitted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 108(a)(ii) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 30)
F3Words in Art. 62(2) inserted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 108(a)(iii) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 30)
F4Words in Art. 62(2) substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 108(a)(iv) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 30)
F5Words in Art. 62(2) inserted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 108(a)(v) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 30)
F6Words in Art. 62(2) omitted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 108(b)(i) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 30)
F7Words in Art. 62(2) inserted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 108(b)(ii) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 30)
F8Words in Art. 62(2) substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 108(b)(iii) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 30)