Quality Risk Management ICH Q9 – Revision published for public comments
HPRA Guide Update to “Labels and Leaflets of Human Medicines”
The Health Products Regulatory Authority (HPRA) issued a revised version of the Guide to labels and Leaflets of Human Medicines on the 10th October 2018, updating from version 18 to 19. The scope of this guidance applies to the labels and package leaflets of medicinal products for human use, authorised nationally, through mutual-recognition or through the decentralised procedure. In this revision the EMA’s Compilation of Quality review of documents decisions on stylistic matters in product information is referenced, which serves as a useful style guide on how product information should be presented on packaging and leaflets. This reference (EMA/25090/2002 Rev. 18) is attached in the link below.
The three main areas of change in the Guide to labels and Leaflets of Human Medicines from revision 18 to 19 are:
- Changes to the process of implementing multilingual text on packaging
- Minor changes to compliance with Braille requirements on packaging
- Changes to requirements for user testing where format or layout changes occur on leaflets
The definition of multilingual packaging in this guidance is a package which is designed for two or more European languages. Section 5.3 of the HPRA Guidance document was updated with new guidance on the requirements relating to the application of multilingual text to labels and leaflets. The provision for multilingual text was always a requirement, however in the recent update, the process for implementing multiple languages on labels and leaflets has changed. Previously, the applicant was required to provide a written declaration at the time of submission of label content, declaring that the label text was identical in all languages that appear on the carton. The HPRA proceeded to perform an assessment of the multilingual information to ensure that it is clear and legible. Now, in version 19 of the HPRA Guide to labels and leaflets, this declaration is no longer required to be submitted. The HPRA will accept, by way of a “blue box” countries” national requirements as highlighted in the Notice to Applicant’s Guideline on the packaging information of medicinal products for human use authorised by the Union and in the CMD(h) guidance on “blue box” requirements, CMDh/258/2012. The minimum requirements in the “Guideline on the readability of the labelling and package leaflet of medicinal products for human use”, ENTR/F/2/SF/jr should also be followed.”
Section 5.3 also includes a statement to encourage the application of multilingual labelling and packaging leaflets for medicines supplied to the Irish market where there is a potential risk to that supply with single-country packaging. The HPRA advise that they are willing to work closely with Marketing Authorisation Holders (MAHs) and other European regulators to help facilitate this.
Additional instructions are included outlining the criteria that multilingual packaging must fulfil. Flexibility is permitted in relation to examples given, e.g. for millilitres: ml or mL are both accepted.
The second main addition to the guidance in revision 19 is the changes surrounding compliance to Braille requirements in section 7.2. It states that Grade 1 Braille, which is uncontracted Braille, is the required type of Braille for use on medicinal packaging in Ireland. It clarifies that “since March 2017, Unified English Braille (UEB) has been the preferred type of contacted Braille for use in Ireland generally, and that previously Standard English Braille (SEB) should have no impact on most of the Braille applied to medicines packaging, with the exception of the Braille used for some mathematical symbols. Applicants should satisfy themselves that the Braille used for any mathematical symbols on its product packaging is in a format suitable for patients in Ireland, is easily readable and clearly comprehensible.
Additional clarification has been provided on the required height of the Braille dots to ensure the readability of the Braille. A target braille height of 0.20mm with 95% of Braille dot height greater than 0.12mm is stipulated in this guidance.
Section 8.2 includes the types of format and layout changes on leaflets that require user testing. This section also identifies changes where user testing is not required. Bridging reports, with evidence from tests on similar packaging leaflets, can be used to support user testing exemptions; these bridging reports should be submitted as Type 1B variations under category C.I.z.
The full guidance document can be found on the HPRA website at the following link:
If you would like further information or wish to discuss how PharmaLex can support you with the submission of new packaging labels and leaflets, or the update of existing packaging please connect with us at +353 1 8466 4742 or contactirl@pharmalex.com.
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