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Pharmaceutical industry: A one-stop resource
Welcome to the pharmaceutical industry area of the MHRA website. This section, which has been developed following feedback from users, provides targeted links to information throughout the site, as well as content relevant to the industry.
If you have any feedback on this section and how we can improve it please email webupdates@mhra.gsi.gov.uk
There is a link at the top of every page of the MHRA website which links directly to the new section.
If you have any feedback on this section and how we can improve it please email webupdates@mhra.gsi.gov.uk
There is a link at the top of every page of the MHRA website which links directly to the new section.
News and hot topics
02 Sep 2010 | Variations legislation 2010 - details of our experience to date, submissions audit and update to FAQs
To help ensure that companies are submitting the new Type IA notifications correctly we have published details of our experience to date, an audit of submissions made in June 2010 and also updated the FAQs.
24 Aug 2010 | Providing information about medicines online - project postponed
Research was undertaken at the beginning of 2010 which indicated that there is a broad consensus among patients/ members of the public on the benefits of providing product information online. Unfortunately, due to the current economic climate, we have no immediate plans to proceed with this development.
13 Aug 2010 | Relocation of the MHRA head office
The MHRA head office in Vauxhall, London, will be moving to a new London location in October 2010. We will ensure there will be minimal disruption to services for all our stakeholders during the move. This new section of the website will be updated as further details about the move become available and will include updated contacts details and specific information for those who work with the Agency.
05 Aug 2010 | New Variations - One Year On
This event, to be held in January 2011 in London, will provide an update on developments arising from the Coordination Group for Mutual Recognition and Decentralised Procedures (CMD), as well as give an opportunity to clarify current guidance.
02 Aug 2010 | Adverse drug reactions: Update on Anonymised Single Patient Reports (ASPRs): July 2010
We have implemented a series of changes to the logic which defines which marketing authorisation holders (MAHs) receive ASPRs/Individual Case Safety Reports (ICSRs).
Fees
This page includes the fees payable for the regulation of medicines, guidance for periodic fees, and how to make payments to the MHRA.
Clinical trials
This page provides links to information on applying for a clinical trial authorisation (CTA), maintaining a CTA, safety reporting and Good Clinical Practice (GCP).
Post marketing authorisation approval
This page provides links to information about post marketing authorisation approval procedures, including variations, renewals, and changes of ownership.
Herbal, homeopathic and borderline medicines
This page provides links to information on how to place a herbal medicine on the UK market, homeopathic medicines and borderline medicines.
Manufacturing and wholesaling
This page provides links to information about manufacturer's and wholesale dealer's licences, including the registers of licensed sites and lists of new, terminated and revoked licences, importing and exporting, and the associated legislation and guidance.
Contacting the MHRA
This page provides links to information about how to contact the MHRA. It also includes an escalation procedure for industry to resolve any issues informally.
Legislation, guidance and policy
This page provides links to information on medicines legislation, guidance and policy. It includes an overview of medicines legislation, including preparing a medicinal product for sale in the UK or EU marketplace, how the MHRA develops policy, and current MHRA consultations relevant to industry.
Applying for a marketing authorisation
This page provides links to all the information needed for obtaining a marketing authorisation (including parallel import licences) in the UK.
Product information and advertising
This page provides links to information on product information (labels, patient information leaflets and packaging) and advertising.
Inspection
This page provides links to information about the different types of inspection, including the inspection process and risk-based inspections, as well as the associated legislation and guidance.
Safety and pharmacovigilance
This page provides links to information about safety and pharmacovigilance, including adverse drug reaction reporting, periodic safety update reports, 'Drug Safety Update', as well as the associated legislation and guidance.
Over-the-counter medicines
This page provides links to the latest information about over-the-counter (OTC) medicines including products containing codeine, pseudoephedrine and children's cough and cold medicines and reclassification of medicines, as well as questions and answers on the new OTC Product Licensing Assessment Team (PLAT) 7.
Medicines for children
This page provides links to information about the regulation of medicines for children, including the requirements for submission of paediatric data and the European paediatric work-sharing procedures.
Page last modified:
24 August 2010
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