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Title:
Addition of Braille to packaging

Reference ID:
12HW

Department Responsible:
Department of Health

Problem Description:
MHRA:
Currently when adding Braille to the outer packaging to comply with Article 56(a), a submission must be made to the Patient Information Quality Unit for assessment. The addition of Braille can be made with other regulatory changes; however a submission and assessment of the Braille is still necessary.

Proposed solution:
Use self-certification to implement the addition of Braille to the outer packaging with guarantees from the MAH that there is no adverse effect on the legibility of the text and confirmation of the Braille text. This could take the form of a signed declaration covering all the required standard conditions.

Cost or time incurred:
Awaiting calculation

Department:
Department of Health

Sector(s):
Private Sector

Category(s):
Science, technology and innovations

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Official response

Thank you for submitting simplification proposals.This reply is in response to number of measures received from ABPI

The majority of the proposals submitted will be progressed under the three main work streams; Patient Information, Authorisation and Pharmacovigilance.
The proposals in relation to bridged user testing for changes to patient information leaflets (PILs) and self-certification of Braille will be taken forward by the Patient Information subgroup, which is due to meet again around October 2008. In the meantime we will be working with industry to progress the proposals that can be taken forward ahead of the meeting.
The proposals regarding pharmacovigilance, including the additional proposals submitted directly to my colleague Mick Foy, together with proposals from the Proprietary Association of Great Britain (PAGB), were also considered by the Pharmacovigilance subgroup on 14 July 2008. The subgroup agreed that the full range of pharmacovigilance proposals submitted by industry would be prioritised by Karen Wood, who attended the subgroup meeting on behalf of the ABPI, for consideration at the subgroup’s next meeting, which is likely to be held in October 2008.
A number of the items concern the processing of new marketing authorisation applications and variations in Licensing Division. The proposal concerning national phase of decentralised and MR applications [3] is currently being addressed in initiatives to meet the 30 days timeline for grant of national marketing authorisations. These were announced on MHRA website on 13 March (http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON014291). The remaining proposals [1, 4, 5, 11] will be considered in detail within the Authorisation work stream, however, as discussed at the plenary meeting on 14 July we would be grateful if the ABPI could submit further background information to expand on the issue regarding excipient updates.
Finally, with regards to the proposal about the eCTD specification for Module 1, we agreed at the Plenary meeting that this would be progressed at the ABPI’s meeting with the MHRA Information Management Division (IMD) later this month following the receipt of further information from ABPI on the issue, which we look forward to receiving. IMD also advised at the meeting that the issue of the acknowledgement of receipt letter and the valid application letter arriving together, and the delays incurred in receiving confirmation regarding cancellation of licences, were expected to be resolved over the next few weeks and did not need to be taken forward as BROMI initiatives.
The MHRA places considerable importance on the continuing participation of stakeholders as a productive way in which Government can continue to identify areas for simplification and reform. We would like to extend our thanks for your time and effort in participating in this process.

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