Volume : 11, Issue : 03, March – 2024
Title:
ROLE OF COPP IN PHARMACEUTICAL EXPORT
Authors :
L.Saipriya*, Dr.B. Thejovathi, Dr.L. Harikiran
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 efcacy 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.
Key words: MHRA, United Kingdom, Product license, eCT
This review includes basics of CoPP, origin of CoPP, types, types of drug includes in CoPP, procedure to obtain CoPP, requirement for CoPP, applicant, examples, format and content and benefits of CoPP. A CoPP is given by the drug regulator not before conducting an inspection of the manufacturing plant. Proper documentation is essential in almost every aspect of the pharmaceutical industry. Whether for product registration, factory inspection, or internal quality control, AdvaCare employs the latest technologies to streamline and process information. All facilities possess up-to-date Good Manufacturing Practice (GMP), CE, TUV, and/or ISO certificates that reflect high quality standards and WHO rules and regulations. Essential product registration documents, such as the Certificate of Pharmaceutical Product (COPP), Free Sales Certificate (FSC), Certificate of Origin (COO), and Marketing Authorizations are among the many documents our registration department frequently submit for registration purposes.
Keywords: Pharmaceutical Industry, COPP , GMP , COO , Drug Regulator.
Cite This Article:
Please cite this article in press L.Saipriya et al, Role Of Copp In Pharmaceutical Export .,Indo Am. J. P. Sci, 2024; 11 (3).
Number of Downloads : 10
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