Informational UK – Contingency legislation covering regulation of medicines and medical devices in a no deal scenario – Human Medicines and Medical Devices (Amendm

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JoshuaFroud

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#2
Morning Marcelo

The first link here (and the link on your site) to the article apears to be broken? Are you able to fix? Thanks.
 
#4
Hi all! Checking this Amendment there is something I have not clear: the regulation (regulation 7A) now requires the UK responsible person too meet certain reporting requirements, but it refers to the reporting of complaints and reports that the UK responsible person must do to manufacturers and there is nothing about the responsibility of notifying incidents to the MHRA. In addition, the article 122 indicates that manufacturers must report any serious incident and field safety action to the Secretary of State, so it looks like this responsibility still lies with the manufacturer. Does anybody else interpret the same? Thanks!
 
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