Uk Responsible Person Agreement Template Form
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People also ask
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How do I register as a responsible person in the UK?
RPi applications may be submitted through the MHRA Portal from 1 January 2021. The Responsible Person (import) ( RPi ) is described in regulations 45AA and 45AB of the Human Medicines Regulations 2012 (as amended). The RPi should be a UK resident. You will need to provide proof of address and identity when you apply.
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Who can be a UK responsible person?
“A person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer's obligations under these regulations.”
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What is the UK responsible person agreement?
What is a UKRP agreement? A signed contract between an overseas manufacturer and UKRP which contains all the legal terms and responsibilities included in the UK RP service.
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What is a responsible individual UK?
The RI actively maintains and enhances the knowledge, skills and values they need to perform high quality audits and deliver a professional service to their clients. It contributes to the performance of high-quality audits, and thereby safeguards the public interest.
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What is the UK responsible person symbol?
Although there is no specific “UK Rep Symbol,” product documentation, labels, or packaging may need to include information indicating that a UKRP has been appointed to ensure that the manufacturer based outside the UK complies with UK regulations for medical devices.
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How do I register as a responsible person in the UK?
RPi applications may be submitted through the MHRA Portal from 1 January 2021. The Responsible Person (import) ( RPi ) is described in regulations 45AA and 45AB of the Human Medicines Regulations 2012 (as amended). The RPi should be a UK resident. You will need to provide proof of address and identity when you apply.
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Who can be a responsible person?
It can either be an individual person or a position within a company. The primary requirement is that there should be a clearly identifiable person or position responsible for ensuring compliance with regulatory requirements.
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What is the UK responsible person label?
The UK Responsible Person is responsible for 1) verifying you have CE or UKCA marked your medical devices, 2) submitting, managing, and renewing your device registrations, 3) notifying the MHRA of your UK importers and 4) acting as the point of contact between you and the MHRA when needed.
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