Regulation 536/2014 on clinical trials - Need for national

Regulation 536/2014 on clinical trials
- Need for national implementation?
Rechtsanwalt Markus Ambrosius
Sträter Rechtsanwälte
Kronprinzenstraße 20
D-53173 Bonn
Fon: +49 (0) 228-934 54-0
Fax: +49 (0) 228-934 54-54
[email protected]
www.straeterlawyers.de
www.straeterlawyers.de
Legal acts of the Union
Art. 288 TFEU
Regulation
Directive
Decision
Ø general application
Ø directly applicable
Ø binding re. results
Ø form and method
choosen by MS
Ø binding on the
addressee
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1
Ethics Committee
Art. 4
"The ethical review shall be performed by an Ethics
Committee in accordance with the law of the
Member State concerned."
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Ethical review
Ø May encompass aspects addressed in Part I or
Part II of the AR as appropriate.
Ø Review within the timelines for the authorisation
procedure
Ø Opinion is valid for the entire MS
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2
Member State Decision
Ø Refusal of Member State to authorise in case of:
• Disagreement with RMS on grounds referred
to in Art. 8 (2) – opt-out
• Negative opinion of ethics committee
Ø Applies also to
• Subsequent addition of MS (Art. 14 (10))
• Substantial modifications (Art. 19 (2), 20 (7),
23 (4))
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Ethics committees and national legislation
Procedural aspects:
Ø Timing
Ø Additional requests for information
Ø Competence of ethics committees (LKP)
Ø Language requirements
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3
Ethics committees and national legislation
Material aspects:
Ø Scope of ethical review
Ø Dossier requirements (Part I, Part II, additional
aspects?)
Ø Grounds for refusal
Ø Room for detailed guidance of EU?
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Directive 2001/20 and Ethics Committees
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4
Decision-making process
Subject to national law
Ø Consideration of ethics committee opinion
Ø Competence of national authorities
Ø Language issues
Ø Conflicts of interests and independence
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General rules
Art. 9
Ø Protection of personal data
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5
Manufacturing/import
Art. 61
Ø Rules re. manufacturing and import licence need
modification
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Legal Representative
Art. 74
Ø Opt-out re. concept of legal representative
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Damage compensation
Art. 76
Ø System for compensation for any damage in the
form of an insurance, guarantee of similar
arrangement
Ø Form of system to be choosen by Member State
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Corrective measures
- Art. 77
Ø Revocation of CTA
Ø Suspension of CT
Ø Modification request
- Detailed rules to be implemented nationally
- Revocation of Ethics Committee opinion?
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7
Inspection/Fees
Ø General framework available in Art. 78 and 86, 87
Ø Detailed provisions to be drawn up by Member
States
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Amendments of national legislation
Ø AMG + GCP-V need to be revised completely re.
CTA system by NCA
Ø Ethics committee procedure needs to be aligned
with new timelines for authorisation procedure
Ø National legislator needs to decide on the dossier
requirements
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8
What about other issues?
Ø Authorisation requirement pursuant to
StrahlenSchutzVO?
Ø Could remain unchanged (Art. 91)
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Discussion
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Thank you very much for
your attention!
Rechtsanwalt
Markus Ambrosius
Sträter Rechtsanwälte
Kronprinzenstraße 20
D-53173 Bonn
Fon: +49 (0) 228-934 54-0
Fax: +49 (0) 228-934 54-54
[email protected]wyers.de
www.straeterlawyers.de
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