Pharmaceutical industry: A one-stop resource

EU additional monitoring list for medicines


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

Man reading news on a computer - home

08 Sep 2014 | Reminder to cancel licences by 31 December 2014

Important information for holders of authorisations, registrations and licences.

01 Aug 2014 | Safety feature (Falsified Medicines Directive): 'black' and 'white' lists (MLX387)

MHRA seeks views on the listing of prescription medicines that shall not bear the safety feature and non-prescription medicines that shall bear the safety feature (falsified medicines directive).

17 Jun 2014 | New EU Clinical Trials Regulation published

On 27 May 2014, the Clinical Trials Regulation was published in the Official Journal of the EU (OJEU).

The unwanted display of the text is removed here...dont delete this

Fees

Invoice - home
This page includes the fees payable for the regulation of medicines, guidance for periodic fees, and how to make payments to the MHRA.
The unwanted display of the text is removed here...dont delete this

Clinical trials

Clinical trials - home
This page provides links to information on applying for a clinical trial authorisation (CTA), maintaining a CTA, safety reporting and  Good Clinical Practice (GCP).
The unwanted display of the text is removed here...dont delete this

Post marketing authorisation approval

Box of pils - home
This page provides links to information about post marketing authorisation approval procedures, including  variations, renewals, and changes of ownership.
The unwanted display of the text is removed here...dont delete this

Herbal, homeopathic and borderline medicines

Herbal and homeopathic - home
This page provides links to information on how to place a herbal medicine on the UK market, homeopathic medicines and borderline medicines.
The unwanted display of the text is removed here...dont delete this

Manufacturing and wholesaling

Man standing by a pile of boxes - home
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.
The unwanted display of the text is removed here...dont delete this

Contacting the MHRA

Contacting the MHRA - home
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

Legislation, guidance and policy - home
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

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.

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.

Inspection

Inspection - home
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

Safety and pharmacovigilance - home
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

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.

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.
Page last modified: 25 April 2013