INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016
Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI)
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.
Keywords:
Medical and Healthcare Products Regulatory Agency (MHRA), United Kingdom (UK), European Union (EU), Brexit, electronic CTD, Yellow Card
Cite Article:
"POST-BREXIT REGULATIONS OF DRUG PRODUCTS AND MEDICAL DEVICES IN THE UNITED KINGDOM", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.8, Issue 7, page no.b668-b672, July-2023, Available :http://www.ijnrd.org/papers/IJNRD2307174.pdf
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ISSN:
2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
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