Paper Title
POST-BREXIT REGULATIONS OF DRUG PRODUCTS AND MEDICAL DEVICES IN THE UNITED KINGDOM
Article Identifiers
Authors
Dr. P. Shailaja , S. Jhansi , T. Susmitha , G. Snehalatha
Keywords
Medical and Healthcare Products Regulatory Agency (MHRA), United Kingdom (UK), European Union (EU), Brexit, electronic CTD, Yellow Card
Abstract
The Medical and Healthcare Products Regulatory Agency (MHRA) is the regulatory body in the United Kingdom. The MHRA is the in-charge for regulation of pharmaceuticals and medical devices in the UK. The term Brexit refers to United Kingdom’s exit from European Union. Before Brexit, the guidelines for marketing medical devices and pharmaceuticals were under the European Medicines Agency (EMA) jurisdiction. On January 31, 2020, the United Kingdom formally exited the European Union. Thus, the Medical and Healthcare Products Regulatory Agency was created. The United Kingdom comprises four nations namely Scotland, Wales, England and Northern Ireland. The licensing for drug marketing was done in the portal of the Medical and Healthcare Products Regulatory Agency website. The documents are submitted in electronic Common Technical Document format by the applicant through the MHRA portal. There are various new marketing authorization assessment routes announced by MHRA for the marketing of drugs and medical devices. The Yellow Card scheme was developed in the UK for collecting adverse effects data of medicinal products directly from patients online on the website of the Medical and Healthcare Regulatory Products Agency which aids in medication research and new drug investigation.
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How To Cite (APA)
Dr. P. Shailaja, S. Jhansi, T. Susmitha, & G. Snehalatha (July-2023). POST-BREXIT REGULATIONS OF DRUG PRODUCTS AND MEDICAL DEVICES IN THE UNITED KINGDOM. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 8(7), b668-b672. https://ijnrd.org/papers/IJNRD2307174.pdf
Issue
Volume 8 Issue 7, July-2023
Pages : b668-b672
Other Publication Details
Paper Reg. ID: IJNRD_201462
Published Paper Id: IJNRD2307174
Downloads: 000122002
Research Area: Pharmacy
Country: Visakhapatnam, Andhra Pradesh, India
Published Paper PDF: https://ijnrd.org/papers/IJNRD2307174.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2307174
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