Instructions for applicants for implementation of Braille script on the packaging
Instructions for marketing authorisation holder for implementation of the Braille script on the package
(Version 1,3 January 2013)
Under Articles 42 and 148 of the Medicinal Products Act (Official Gazette No. 71/07, 45/09 and 124/11) the name of medicinal product in the Braille script will be mandatory indicated after accession of the Republic of Croatia to the EU and data about the implementation of Braille script will make an obligate part of documentation submitted for granting marketing authorisation.
Taking account of the future mandatory use of the Braille script on the packaging of medicinal products before the Croatia's accession to the EU, HALMED encourages marketing authorisation holders for an early implementation of this obligation.
The name of the medicinal product in the Braille letter on the packaging should be indicated in a way that facilitates clear medicinal product recognition to blind and partially sighted persons., under Article 56a of the Directive 2001/83/EC and European Commission "Guidance concerning the Braille requirements for labelling and the package leaflet" and in compliance with "HRN EN 15823:2011 Packaging - Letter for blind on the packaging for medicinal products (EN 15823:2010)".
Under current legislation, the implementation of the medicinal product name in the Braille script on the package is considered a variation in labelling of the medicinal product not associated with a variation in the Summary of Product Characteristics, or variation under Article 41.a of the Ordinance on granting the marketing authorisation of medicinal product (Official Gazette, No. 113/08 i 155/09).
In order to implement the Braille script on the packaging before the accession to the EU, the marketing authorisation holder is required to:
- submit an application for variation under Art. 41.a of the Ordinance on granting the marketing authorisation (Official Gazette, No. 113/08 i 155/09)
- indicate the type of variation as "variation II others"
- will be charged as a variation indicated in the "Applicable to national procedures by the date of accession after accession of the Republic of Croatia in the EU" part under 3.2.1 of the HALMED price list
- notify as a variation in upgrading that may be included in the application for upgrading (case 184.108.40.206.a Instructions for application submission for dossier upgrading, as of 19 November 2012)
- will not be separately charged, it is included in the price of dossier upgrading
- provide necessary data in the marketing authorisation procedure
- will not be separately charged, it is included in the price of marketing authorisation procedure.
For medicinal products with already implemented Braille letter on the package through regulatory procedures completed earlier, but without submitted documentation for the aforementioned in compliance with this instruction and have not received a HALMED authorisation, marketing authorisation holders should proceed according to the aforementioned under I or II.
The documentation needed for the authorisation of indicating or waiver of indicating the Braille script through the variation or authorisation upgrading or marketing authorisation procedure should include the following (alongside the standard documentation for the aforementioned applications):
- labelling proposal
- provide a labelling proposal and in case of the Braille script application through a variation procedure or authorisation upgrading, provide a labelling proposal with indicated changes and in the final
- in the labelling proposal of the medicinal product it should be indicated:
"Information in the Braille script" and indicate data in the Latin script that will be written in the Braille script
"Information in the Braille script: accepted justification for the non-indicating of the Braille script", in case when data on the labelling should not be indicated in the Braille script according to the "Guidance concerning the Braille requirements for labelling and the package leaflet", about the justification will HALMED decide in the assessment procedure.
- 2. proof of the accuracy of data indicated in the Braille script on the package issued by a federation, association or institution for blind and partially sighted officially registered in the Republic of Croatia qualified to verify the correctness of data in the Braille script, according to "Guidance concerning the Braille requirements for labelling and the package leaflet" and standard "HRN EN 15823:2011 Packaging - Letter for blind on the packaging of medicinal products (15823:2010)".
- for accuracy confirmation a standard application form should be used (.doc, .pdf)
- in case when the accuracy proof is obtained before publication of these instructions, the proof should contain at least the following data to accept:
- data proposal in the Latin script that will be indicated in the Braille script on the packaging
- data print out from the paragraph 1. in the Braille script
- accuracy of data in the Braille script confirmed by a signature and seal of a union, association or institution for blind and short sighted persons officially registered in the Republic of Croatia.
- Justification for non-indicating of data in the Braille letter (Modul 1.3.6) when applicable for a medicinal product according to the "Guidance concerning the Braille requirements for labelling and the package leaflet".