The MHRA guidance documents on minimum clinical particulars for summaries of product characteristics (SmPCs) of prescription only (POM) non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and over-the-counter (OTC) ibuprofen, for systemic administration, have been revised:
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Minimum clinical particulars for pharmacy (P) and general sales list (GSL) Ibuprofen for systemic administration - Guidance to marketing authorisation (MA) holders
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Minimum clinical particulars for non-selective prescription only (POM) NSAIDs for systemic administration (excludes aspirin/ salicylic acid derivatives) (86Kb)
These documents outline the key elements for SmPCs, and a number of key points required in the patient information leaflet (PIL) and labelling wording. These are continually updated in order to bring them line with emerging medical and scientific information. MA holders should note that these guidance documents do not represent comprehensive guidance for NSAID SmPCs, they only address key minimum information. Therefore MA holders should ensure that all the relevant NSAID class warnings, including product specific warnings, are included in the product information. These updated versions (dated November 2007), replace the current documents last revised August 2004.
The revised documents incorporate current published information, including information obtained from the following:
- current MHRA Expert Advisory Committees advice
- key elements for non-selective NSAIDs adopted by the EMEA Committee on Human Medicinal Products (CHMP) during its plenary in October 2005
- cardiovascular and cerebrovascular warnings for non-selective NSAIDs for systemic administration agreed by the EMEA Pharmacovigilance Working Party (PhVWP) in December 2006
- key elements for non-selective NSAIDs Piroxicam, Ketoprofen and Ketorolac adopted by the CHMP - September 2006
- commission decision dated 7 September 2007 of Article 31 of Directive 2001/83/EC on Piroxicam (this supersedes the Piroxicam wording adopted by CHMP in September 2006)
Implementation
We are in the process of writing to all MA holders affected by these updates.
MA holders are invited to update their non-selective NSAID licences for systemic administration in line with the new guidance documents by submitting Type II variations within 6 months (by 31 July 2008); or they should provide a declaration that variations are not required where the prescribing information is up to date. You will be required to start incorporating updated leaflets into new production batches within a 3-6 month timeframe. The declaration should be sent to therapeuticreviewsgroup@mhra.gsi.gov.uk and should be marked for the attention of Ms Dee Mthimkhulu and Ms Anne Ambrose.
The variations will attract the usual fee(s). Currently pending renewal applications will be finalised when the variations are determined.
PILs being prepared for submission in relation to Compliance with Articles 59(1) and 59(3) of Council Directive 2001/83/EC should include the wordings. If you have already undertaken User Testing on leaflets that do not include the suggested wording the MHRA will not expect the user-testing to be repeated in every case.
As you are aware MA holders have an obligation to keep marketing authorisations up to date and the product information should reflect current medical and scientific knowledge.
Further information
For further advice on the submission of your variation please contact Ms Dee Mthimkhulu (Tel: 020 3080 6815) or Ms Anne Ambrose (Tel: 020 3080 6186); alternatively you may email us at therapeuticreviewsgroup@mhra.gsi.gov.uk
