Medicines regulatory news

This section provides the latest information about the regulation of medicines, including information that was previously published in 'MAIL', our updating journal for medicines which ceased publication at the end of 2007.

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Latest medicines regulatory news

• 04 Sep 2008| Statement on non-medical prescribing and mixing medicines in palliative care

  We have issued a statement on non-medical prescribing and mixing medicines in palliative care.

• 03 Sep 2008| Variation application form template for antiepiletic drugs

  We have produced an application form template for the variation to a marketing authorisation for antiepileptic drugs.

• 29 Aug 2008| Public consultation: Proposals for amendments to medicines legislation to allow dispensing opticians access to certain prescription only medicines (poms)

  We have published a public consultation covering proposals for amendments to medicines legislation to allow dispensing opticians access to certain prescription only medicines (poms).

• 21 Aug 2008| Recent reclassifications of medicines

  The maximum strength of GSL liquid paracetamol preparations for adults and children aged 12 years and over has been increased from 2.5% to 5%.

• 12 Aug 2008| Report on the importation of unlicensed medicines, Quarter 2, 2008

  We have published a quarterly report on importation of unlicensed medicines.

• 05 Aug 2008| Patient information leaflet (PIL) of the month: Saw Palmetto capsules added

  The patient information leaflet for Saw Palmetto capsules has been added to the 'Patient information leaflet of the month' section.

• 04 Aug 2008| Changing the name of a company for authorisations held under Medicines Regulations

  A new procedure has been introduced for any company that intends to change its name. This applies to all companies or legal entities which hold any authorisation under Medicines Regulations. It also affects any companies listed on any authorisations in some capacity (e.g. a manufacturer, wholesale dealer etc.).

• 01 Aug 2008| Recent reclassifications of medicines

  An additional indication has been introduced for General Sale List (GSL) medicines containing loperamide hydrochloride 2mg.

• 29 Jul 2008| Guidance on the MHRA’s handling of the requirement in the Paediatric Regulation to undertake a ‘compliance check’ during validation

  We have published guidance to companies on how we intend to handle the impact of the requirements of the Paediatric Regulation on the validation of applications for marketing authorisations.

• 24 Jul 2008| Update on the "Sunset Clause": One-off exercise to establish the marketing status of all medicinal products on the UK market

  We have undertaken a one-off exercise to establish the marketing status of all medicinal products on the UK market, whether they have purely national authorisations, or were authorised under the decentralised or mutual recognition procedures.