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UK MHRA: MHRA Fees 2023 & Guidance on How to Draft a Direct Health Care Professional Communication

A new statutory fee for MHRA services was introduced on April 1, 2023, by the Medicines and Healthcare Products Regulatory Agency (MHRA) United Kingdom.

MHRA charges fees for a range of services related to medicine regulation, medical device regulation, and other healthcare product regulations in the United Kingdom.

These fees are set by the UK government and reviewed annually.

The MHRA fees for 2023 - 2024 have increased from 2022 - 2023.

Earlier today (04 April 2023) UK's Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance on "Guidance on How to draft a Direct Health Care Professional Communication" which is designed to help ensure that all communication between the MHRA and MAHs is clear, concise, and effective, which ultimately benefits patients by helping to ensure the safety and efficacy of pharmaceutical products.

A direct healthcare professional communication (DHPC) receives direct communications from marketing authorisation holders or the licensing authority regarding a marketed medicine so that it can be used safely and effectively.

The UK's direct healthcare professional communication letters should always include a 'call for reporting' section that describes the national system for reporting suspected adverse drug reactions.

A call for reporting is a request for pharmaceutical companies, healthcare professionals, and members of the public to report adverse reactions or incidents related to medical products or devices. As part of its pharmacovigilance system, the MHRA monitors and assesses the safety of medicines and medical devices. This call for reporting is an essential part of its pharmacovigilance system.

Click this LINK to understand and how to communicate and coordinate safety information concerning medicinal products authorised in the UK.


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