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Abstract
MHRA (Medicines And Health Products Regulatory Agency) is the regulatory authority body for pharmaceuticals approval in the UK union. MHRA is formed by the merging of two separate agencies in 2003 i.e., Medicines Control Agency and Medical Device Agency. This agency works to maintain safety, quality and efficacy of the drug product before it enters into the country. The main aim of this work is to know about the practice and the regulatory requirements for the registration of a drug in the UK as per the regulations of MHRA. They are responsible for ensuring that the medicines and medical devices are acceptably safe and don’t cause any harm to the patients. MHRA provides a license which is a marketing authorization to the manufacturer, required before a drug is being used by the patients of that country. Good Manufacturing Practice (GMP) is the minimum requirement that a manufacturer should possess during the period of production of the drug product. New drugs are being invented and also being distributed as per the needs of the patients. It is known that no drug product is completely safe or is 100% safe for use, but MHRA tries to minimize as many problems regarding the drug so that patients will be provided with the best drug with minimal risk.
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References
- 1. Dossier definition [internet], available at. http://www.thefreedictionary.com/dossier Reclassification procedures. available at http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/ Legalstatusandreclassification/index.htm
- 2. MHRA introduction: Medicines & Medical Devices Regulation , available at http://www.mhra.gov.uk/home/groups/commsic/documents/websiteresources/con2031677.pdf, page no.2;
- 3. Marketing Authorisation Procedures: Notice to applicants[Internet]; VOLUME 2A Procedures for marketing authorization Chapter 1 Marketing Authorisation, available at http://ec.europa.eu/health/files/eudralex/vol2/a/vol2a_chap1_2005-11_en.pdf.
- 4. Scientific guidelines: status of EMEA scientific guidelines and European Pharmacopoeia monographs and chapters in the regulatory framework applicable to medicinalproducts, available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004008.pdf
- 5. Labelling requirements: Best practice guidance on labelling and packaging of medicines, available at http://www.mhra.gov.uk/home/groups/commsic/documents/publication/con007554.pdf
- 6. Bioequivalence requirements: guideline on the investigation of bioequivalence, availableathttp://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC50007.
- 7. Renewaloflicences:[internet],availableat http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Marketingauthorisations/Renewaloflicences/index.htm.
- 8. http://www.mhra.gov.uk/home/groups/commsic/documents/websiteresources/con2031677.pdf.2
- 9. http://www.pharmaguideline.com/2010/10/mhra.html.
- 10. https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatoryagency/services-information.
- 11. http://www.orajournal.com/vol1issue4/nov2013/c27.1.pdf.
- 12. https://en.wikipedia.org/wiki/Medicines_and_Healthcare_products_Regulatory_Agency.
- 13. https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distributionpractice
References
1. Dossier definition [internet], available at. http://www.thefreedictionary.com/dossier Reclassification procedures. available at http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/ Legalstatusandreclassification/index.htm
2. MHRA introduction: Medicines & Medical Devices Regulation , available at http://www.mhra.gov.uk/home/groups/commsic/documents/websiteresources/con2031677.pdf, page no.2;
3. Marketing Authorisation Procedures: Notice to applicants[Internet]; VOLUME 2A Procedures for marketing authorization Chapter 1 Marketing Authorisation, available at http://ec.europa.eu/health/files/eudralex/vol2/a/vol2a_chap1_2005-11_en.pdf.
4. Scientific guidelines: status of EMEA scientific guidelines and European Pharmacopoeia monographs and chapters in the regulatory framework applicable to medicinalproducts, available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004008.pdf
5. Labelling requirements: Best practice guidance on labelling and packaging of medicines, available at http://www.mhra.gov.uk/home/groups/commsic/documents/publication/con007554.pdf
6. Bioequivalence requirements: guideline on the investigation of bioequivalence, availableathttp://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC50007.
7. Renewaloflicences:[internet],availableat http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Marketingauthorisations/Renewaloflicences/index.htm.
8. http://www.mhra.gov.uk/home/groups/commsic/documents/websiteresources/con2031677.pdf.2
9. http://www.pharmaguideline.com/2010/10/mhra.html.
10. https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatoryagency/services-information.
11. http://www.orajournal.com/vol1issue4/nov2013/c27.1.pdf.
12. https://en.wikipedia.org/wiki/Medicines_and_Healthcare_products_Regulatory_Agency.
13. https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distributionpractice