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 4, July 2019)
The name of the medicinal product in the Braille script on the packaging should be indicated in a way that facilitates clear medicinal product recognition to blind and partially-sighted persons, in line with Article 56a of the Directive 2001/83/EC and European Commission "Guideline on the readability of the labelling and package leaflet of medicinal products for human use" and "HRN EN 17351:2014 Packaging - Braille on packaging for medicinal products (ISO 17351:2013; EN ISO 17351:2014)".
In order to implement the Braille script on the packaging, the marketing authorisation holder is required to:
- provide necessary data in the marketing authorisation procedure
- will be included in the price of marketing authorisation procedure and will not be separately charged.
- submit an application for variation under Art. 36 of the Ordinance on granting the marketing authorisation for medicinal products (Official Gazette, No. 83/13, 28/20 and 32/21)
- will be charged as a variation indicated under 3.2.1 of the HALMED price list ( Variation to labelling and/or package leaflet, including variation of a mock-up of inner and outer packaging, that does not require changes in the summary of product characteristics).
The documentation needed for the authorisation of indicating or waiver of indicating the Braille script through the variation 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, provide a labelling proposal in a mark up version and a clean version
- labelling proposal should include:
- data in the Latin script that will be written in the Braille script
- statement "Accepted justification for the non-indicating of the Braille script", in case that the data on the labelling is not required to be indicated in the Braille script according to the "Guideline on the readability of the labelling and package leaflet of medicinal products for human use", whereby HALMED will decide of the justification of this statement in the assessment procedure.
- proof of accuracy of the data indicated in the Braille script on the packaging issued by a union, association or institution for the blind and partially-sighted officially registered in the Republic of Croatia qualified to verify the correctness of data in the Braille script, according to "Guideline on the readability of the labelling and package leaflet of medicinal products for human use" and "HRN EN 17351:2014 Packaging - Braille on packaging for medicinal products (ISO 17351:2013; EN ISO 17351:2014)".
For data accuracy confirmation a standard application form should be used (.docx, .pdf).
If the product name in Croatian is identical to the medicinal product name authorised in one of the EU/EEA countries and the medicinal product does not have additional doses or pharmaceutical forms, thus they do not need to be indicated in the Braille script, a proof of accuracy of the Braille script issued by a union, association or institution for blind and partially-sighted persons from the EU/EEA countries (if in the Latin script) can be delivered to HALMED.
- Justification for non-indicating of data in the Braille script (Modul 1.3.6) when applicable for a medicinal product according to the "Guideline on the readability of the labelling and package leaflet of medicinal products for human use".