Labels and leaflets: Applications for assessment

Article 61(3) of Directive 2001/83/EC provides that all proposed changes to the label or leaflet covered by the Directive, and not connected with the Summary of Product Characteristics (SPC), must be submitted for review. The flat rate fee for the assessment of these changes to labels and leaflets is currently £524.

A single fee will cover the assessment of all changes to a single version of the label and leaflet for one product, submitted at the same time.

As for variations, bulk fee discounts of one full fee with a 50% reduction in further fees for applications submitted together has been implemented. These will apply where identical changes are being made across a range of different strengths of the same dosage form. Where the changes to a second or subsequent version of the packaging components are identical to those proposed to the first version of the packaging, and are submitted at the same time, the bulk fee provisions will apply.

However, where other changes are proposed to a second or subsequent version of the label and leaflet, a separate application must be submitted accompanied by the appropriate full fee.

There will be no additional fee for assessing changes to labels and leaflets required as a result of variations to the SPC since the appropriate variations fee covers these. However, any other changes, not consequent to the SPC change, will require application to and assessment by the Patient Information Quality Unit.  Hence, if the Patient Information Quality Unit, (consequent to the variation application) is required to undertake a separate assessment, then a separate fee will be levied  If any inconsequential changes to labels and PILs have been approved at the same time as a change to the SPC, you will be specifically notified in the variation approval letter. Alternatively, should it be necessary to undertake a separate assessment of the packaging components you will be advised in the variation approval letter that this is the case, the reason for this and a reminder that a fee will be charged. The MHRA will not levy a fee when revisions to the label or leaflet are submitted solely in order to incorporate safety changes requested by the Agency.

An application form for submission of label and leaflet applications is below.  Where bulk provisions apply, one application form should be completed together with an accompanying list of products affected. Submissions should be made, preferably electronically, as detailed in Special Mail 5.

› Application form for changes to labels and patient information leaflets (36Kb)

Code of practice for pack design for over the counter medicines
Council Directive 2001/83/EC as amended, requires that marketing authorisation holders (MAH) inform the competent authority of all changes to the labelling which are not connected to changes to the Summary of Product Characteristics (SPC) [Article 61(3)]. Notwithstanding the need to notify the competent authority of the amendment, responsibility for the information presented on the packaging rests solely with the MAH.

Article 62 of the Directive permits the inclusion of additional information on the labelling of medicines provided it is compatible with the SPC, useful for the patient and non-promotional. Information of this nature is termed non-statutory and a Code of Practice which deals with this has been developed for use by the over-the-counter (OTC) medicines sector. The code of practice is available from the Proprietary Association of Great Britain (PAGB).

› Code of practice for pack design for over the counter medicines (16Kb)

Contact for further information
The Unit responds to and investigates enquiries and complaints regarding patient information reported by members of the public and the pharmaceutical industry. Enquiries and complaints should be made in writing and sent to: The Patient Information Quality Unit, MHRA, 14-1, Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ or e-mail patient.information@mhra.gsi.gov.uk.