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NHS foundation trusts, those organisations defined as 'high-performing' hospitals and are run as not-for-profit corporations, have an additional layer of regulatory oversight provided by the economic regulator - Monitor - which imposes authorisation standards in relation to internal governance and financial viability.
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The technical regulation restricts international trade by imposing an authorisation requirement for SVHC listed in Annex XIV REACH and that are used in imported articles.
"Prior to an application for a warrant, a Public Interest Advocate must be notified of the pending application and given the opportunity to make submissions regarding the application, including any conditions or restrictions that might be imposed on authorisations made under the warrant".
Although the draft Regulation refers to the authorisation by a judicial authority for conducting on-site inspections, it imposes the obligation to apply for such authorisation only if this is required by national rules (Article 12 - Authorisation by a judicial authority).
PAMs are especially imposed on conditional marketing authorisations or when marketing authorisations have been granted under exceptional circumstances.
However, if according to the ethics committee the research imposes serious risks to the participant's private life or bodily integrity, authorisation to participation must be given by the tutelary judge.
"You can get a warrant to search and seize stuff, but since when did law enforcement have the authorisation to impose punishments on their own?
Pharmaceutical industry standards, such as good manufacturing practice (GMP) and marketing authorisation, were imposed upon the predominantly hospital-based human tissue transplantation field.
In France, authorisation is required from a judge if an ethics committee rules that the research imposes serious risks to the participants.
This law imposes that".
Geography also imposes limits.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com