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The UK is leaving the European Union on March 29, 2019. “We remain focused on delivering the deal that we have negotiated with the EU,” the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said. Following consultations on how medicines, medical devices and clinical trials would be regulated in a no-deal scenario, the MHRA has issued updated guidance setting out the UK’s proposed arrangements for regulation if it leaves the EU on March 29, 2019, with no deal. For medicines, the key arrangements include automatically converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), a process known as ‘grandfathering’, among others. For medical devices, the key arrangements include for a time-limited period, devices that have a CE mark from a notified body based in the UK or an EU country will continue to be recognised by UK law and allowed to be placed on the UK market. For clinical trials, the arrangements include continuing to recognise existing approvals so there will be no need to re-apply, the MHRA said.
Organ donation
A moving New Year gesture
Gunshot victim Archana Gupta was brought to the emergency wing of Fortis Flt Lt Rajan Dhall Hospital (FHVK) in New Delhi at 00:18 am on New Year’s Day, 2019, in an extremely critical condition and was declared brain dead by the attending doctors on January 2. Her family, displaying enormous strength and grit in their hour of grief, decided to donate her kidneys, a note from the hospital said. An NOC was obtained from the Delhi Police since this is a medico-legal case.
Once the patient was declared brain dead on January 2, the proposal to donate her organs was discussed with the family. According to NOTTO (National Organ and Tissue Transplant Organisation), once a patient is declared brain dead, the hospital can approach the family for organ donation. After the necessary approvals and procedures as outlined by NOTTO, one kidney was sent to Apollo Hospital and the other given to FHVK, the note added.
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