UK MHRA makes submission of mock-ups of drug labels/leaflets more flexible
This article was originally published in SRA
The UK Medicines and Healthcare products Regulatory Agency has made the procedure under which drug companies submit mock-ups of labels and patient leaflets more flexible1,2.
As of 1 April, companies are no longer limited to submitting their labels and patient leaflets mock-ups in full colour only, according to the MHRA, which has introduced alternative formats for making such submissions.
The changes to the procedure concern initial and final submission documents for new marketing authorisations as well as Type 1B and Type II variation applications. They were introduced following consultation with pharmaceutical industry associations.
New marketing authorisations
For new marketing authorisations – including extension applications – the changed procedure applies to all applications evaluated under the mutual recognition, decentralised and UK-only procedures. It provides companies with the option of supplying either full-colour mock-ups with the first submission (Day 0) or word document formats using templates provided by the European Medicines Agency.
Prior to a marketing authorisation being granted (during the "national phase" in mutual recognition/decentralised procedures), companies should provide full colour mock-ups. However, if there are no plans to place the product on the market for six months or more after the anticipated date of approval, a corrected word document template can be provided instead. Where the marketing authorisation is granted without full colour mock-ups, these must be submitted for approval before the product is placed on the market either through a variation application or by making a submission to the MHRA's Patient Information Quality (PIQ) unit.
Variation applications
For variation applications concerning a drug's labelling or patient leaflet, the changed procedure covers mutual recognition and UK-only variation procedures.
Under this, a company has the choice of submitting: full colour mock-ups with the first submission (Day 0); a word document format using the EMA template; or a PDF version of the existing labelling and/or patient leaflet with the changes annotated (in Adobe). Before a variation is granted, full colour mock-ups must be submitted taking account any changes the MHRA required after assessing the company's initial submission or otherwise following the agency's "approvable" letter.
In general, the choice of the submission format would depend on the extent of changes that need to be made to the labelling or the leaflet. For example, where there are several complex changes of text in Type II variations it may be better to start with a Word template submission rather than an annotated PDF. But in Type 1B mutual recognition variation procedures where the UK is the concerned member state, the MHRA strongly recommends that companies submit clean new mock-ups at Day 0 because there is no "national phase" and there may be no questions raised by the reference member state.
References
1. MHRA news, 29 March 2012, www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON146893
2. MHRA, Labels & Patient Leaflets in the Initial & Final Submission Documents for New MA and Type 1B or Type II Variation Applications, 29 March 2012, www.mhra.gov.uk/home/groups/comms-ic/documents/regulatorynews/con146894.pdf