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.
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).
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.
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.
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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.
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.
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.
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.
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.