Medicinal Products

Instructions for applicants for implementation of Braille script on the packaging

Instructions for marketing authorisation holders for implementation of Braille script on the packaging
(Version 5, November 2025)

In line with Article 94 of the Medicinal Products Act (Official Gazette Nos. 76/13, 90/14, 100/18, and 136/25.), the name of the medicinal product in Braille script should be indicated on the packaging.

The name of the medicinal product in Braille script on the packaging should be indicated in a way that facilitates clear recognition of the medicinal product to blind and partially sighted persons, in line with Article 56a of the Directive 2001/83/EC and the 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 Braille script on the packaging, the marketing authorisation holder is required to:

1. provide the necessary data in the marketing authorisation procedure
   • this will be included in the price of the marketing authorisation procedure and will not be separately charged.
2. submit an application for variation under Article 36 of the Ordinance on granting the marketing authorisation for medicinal products (Official Gazette, No. 83/13, 28/20 and 32/21)
   
   • this will be charged as a variation indicated under point 3.1.4 for national procedures and under point 3.2.3 for MRP/DCP procedures in HALMED price list (Change in the labelling and/or package leaflet, including a mock-up change of the inner and outer packaging, which is not related to the changes in the summary of product characteristics).

The documentation needed for the authorisation of indication or waiver of indication of Braille script through the variation or marketing authorisation procedure should include the following (alongside the standard documentation for the aforementioned applications):

1. Labelling proposal
   1. provide a labelling proposal and, in case of the Braille script application through a variation procedure, provide both a mark-up version and a clean version
   2. the labelling proposal should include:
      - data in the Latin script that will be written in the Braille script, or
   3. the statement "Accepted justification for the non-indicating of Braille script", in case that the data on the labelling is not required to be indicated in 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 on the justification of this statement during the assessment procedure.
2. Proof of accuracy of the data indicated in 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 Braille script, according to the "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 these do not need to be indicated in Braille script, proof of accuracy of the Braille script issued by a union, association or institution for blind and partially sighted persons from an EU/EEA country (if in the Latin script) may be delivered to HALMED.
   
   or
   
   
3. Justification for non-indicating of data in 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".