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.
EMA have launched a public consultation on the functional specification for a portal and database that will underpin the EU Clinical Trials Regulation. Stakeholders are invited to review the document and provide comments to the EMA by 31 October 2014.
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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.