Allgemeines » Renewal of Licenses

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
鈥?MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).
鈥?In April 2013 Youth Oscar Klefbom Jersey , it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with MHRA identity being used solely for the regulatory centre within the group. The Agency employs more than 1,300
鈥?It was located in Vauxhall Youth Kailer Yamamoto Jersey , London and is now relocated to 151 Buckingham Palace Rd, London SW1W9.
History
鈥?In 1999, the Medicines Control Agency (MCA) took over control of the General Practice Research Database (GPRD) from Office for National Statistics.
鈥?Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form MHRA. In April 2012 Youth Alex Chiasson Jersey , the GPRD was expanded and relaunched as the Clinical Practice Research Datalink (CPRD).
鈥?In April 2013, MHRA merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with MHRA identity being used for the parent organisation and one of the centres within the group. At the same time CPRD was formally declared a separate centre of MHRA Youth Cam Talbot Jersey , too.
Structure
MHRA is divided into three main centres:
鈥?MHRA Regulatory (the regulator for the pharmaceutical and medical devices industries)
鈥?Clinical Practice Research Datalink
鈥?National Institute for Biological Standards and Control
Aims
鈥?Protect the public health
鈥?Promoting the public health
鈥?Improving the public health
Objectives
鈥?Safeguard public health by ensuring that the products we regulate meet required standards and are acceptably safe,
鈥?Communicating accurate, timely and authoritative information to healthcare professionals Youth Kyle Brodziak Jersey , patients and the public.
鈥?Support research and ensure that Better Regulation principles so that regulation does not stifle innovation,
鈥?Influence the shape of the future regulatory framework through effective European and International relationships,
鈥?Run an organization with a skilled and equipped workforce that is fit for the future.
Roles
鈥?Operate post-marketing surveillance for reporting Youth Milan Lucic Jersey , investigating and monitoring of adverse drug reactions to medicines and incidents with medical devices.
鈥?Assessment and authorisation of medicinal products for sale and supply in UK.
鈥?Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market.
鈥?Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.
鈥?Investigate internet sales and potential counterfeiting of medicines, and prosecute where necessary.
鈥?Provide Regulatory Training & eCTD Training
鈥?Regulate clinical trials of medicines and medical devices.
鈥?Monitor and ensure compliance with statutory obligations relating to medicines and medical devices.
鈥?Promote safe use of medicines and devices.
Funding
MHRA is funded by the Department of Health and Social Carefor the regulation of medical devices, whilst the costs of medicines regulation is met through fees from the pharmaceutical industry. This has led to suggestions by some MPs that MHRA is too reliant on industry Youth Darnell Nurse Jersey , and so not fully independent.
Types of applications
1) Full applications
Applications for new active substances are described as 'full applications'.
2) Abridged applications
飩?Applications for medicines containing existing active substances are described as 'abbreviated鈥?or 鈥榓bridged applications鈥?
飩?Existing drugs with new forms, routes and indications. Sometimes, although the drug is the same Youth Tobias Rieder Jersey , the new product has a different strength or pharmaceutical form or is used by a different route or for different clinical uses
飩?Existing drugs in new combinations may also be proposed though they may need a full data package to support them.
飩?鈥榃ell-established鈥?drugs and products - The new product may include a drug substance which has such a well-established medicinal use and an acceptable level of safety that the applicant company can submit published data to support the safety and efficacy aspects of their application. Examples here may include some over-the-counter (OTC) remedies.
3) Informed consent and change of ownership applications
飩?For commercial reasons companies may want to take over or duplicate a product license held by another company. Where the first company agrees to this 'informed consent' approach, the second company can get an exact copy license commonly known as a 'piggy-back' license.
飩?Alternatively, where the ownership of the company changes hands and the new owners need to take over the old product licenses. These applications are called 'change of ownership' applications
Submission of Application
飩?All applications must follow the common technical dossier (CTD) format which has been a requirement since 2003.
飩?The preferred format for new marketing authorization (MA) applications is the electronic Common Technical Dossier (eCTD).
飩?eCTD applications must be created according to the current specifications.
飩?However Youth Ryan Strome Jersey , MHRA accept that many companies are not yet ready to submit applications in eCTD format. Therefore, it accepts applications in PDF-only format also.


Renewal of Licenses
飩?New Marketing authorizations (MAs) are valid for five years and then may be renewed on the basis of a re-evaluation . Wholesale Jerseys China Wholesale Jerseys From China Wholesale Cheap Jerseys Wholesale Authentic Jerseys Wholesale NFL Jerseys China Wholesale Authentic Jerseys Wholesale NBA Jerseys Online Wholesale MLB Jerseys From China Wholesale Authentic Soccer Jerseys Cheap Authentic NHL Jerseys