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Home Pharmaceutical industry

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 webusability@mhra.gsi.gov.uk or fill out our feedback form.

There is a link at the top of every page of the MHRA website which links directly to this section.

News and hot topics

16 May 2013 | Changes to medicines names: sulphate to sulfate

Further to the nomenclature harmonisation in 2003/04 Changes to medicines names: BANs to rINNs, the European Pharmacopoeia and British Pharmacopoeia have amended the spelling of sulphate to sulfate for all products containing sulfate (or sulfur containing compounds eg sulfonate).

25 Apr 2013 | EU additional monitoring list for medicines

The Pharmacovigilance Risk Assessment Committee (PRAC) has published the European so-called ‘mandatory’ list of medicines under additional monitoring.

14 Mar 2013 | Guidance on submitting label and leaflet mock-ups following variations

In April 2012, following consultation with medicines trade associations and member companies we announced some procedural changes concerning the requirement to submit full-colour mock-ups of labels and patient leaflets. In the last year we have received a number of requests for a copy of the guidance, which we have now published on our website.

14 Mar 2013 | Joint BIA/MHRA Conference: Innovation in the development and regulation of biopharmaceuticals

The third joint BIA and MHRA conference will focus on supporting innovation in the development and regulation of biopharmaceuticals from both regulatory and life sciences industry perspectives.

11 Mar 2013 | Press release: MHRA launches an ‘Innovation Office’ to encourage the development of novel medical products and devices

The MHRA is launching an ‘Innovation Office’ to help organisations who are developing innovative medicines, medical devices or using novel manufacturing processes to navigate the regulatory processes in order to be able to progress their products or technologies.

Go to the news and hot topics page

Fees

This page includes the fees payable for the regulation of medicines, guidance for periodic fees, and how to make payments to the MHRA.

Go to the fees page

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).

Go to the clinical trials page

Post marketing authorisation approval

This page provides links to information about post marketing authorisation approval procedures, including variations, renewals, and changes of ownership.

Go to the post marketing approval authorisation page

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.

Go to the herbal, homeopathic and borderline medicines page

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.

Go to the manufacturing and wholesaling page

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.

Go to the contacting the MHRA page

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.

Go to the legislation, guidance and policy page

Applying for a marketing authorisation

Post marketing authorisation approval - home

This page provides links to all the information needed for obtaining a marketing authorisation (including parallel import licences) in the UK.

Go to the applying for a marketing authorisation page

Product information and advertising

Woman reading a patient information leaflet - home

This page provides links to information on product information (labels, patient information leaflets and packaging) and advertising.

Go to the product information and advertising page

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.

Go to the inspection page

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.

Go to the safety and pharmacovigilance page

Over-the-counter medicines

Medicine being sold over the counter - home

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.

Go to the over-the-counter medicines page

Medicines for children

Mother giving medicine to her child - home

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.

Go to the medicines for children page

Page last modified: 25 April 2013