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.
New requirements for active substances (ASs) imported into the European Economic Area (EEA) for use in the manufacture of authorised medicinal products have been introduced today under the Falsified Medicines Directive 2011/62/EU (the FMD).
Between 18 October 2012 and 19 November 2012 the MHRA ran a public consultation on the transposition of the Falsified Medicines Directive 2011/62/EU into UK legislation. A summary of the responses is now available to read.
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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.