Regulatory Affairs Services

Quality Control of Braille on Packaging Materials

Quality Control of Braille on Packaging Materials

With regards to the mandatory bearing of Braille on the packaging of medicinal products for human use, pursuant to the provision “Braille format implementation, TEMPORARY ARTICLE 2 (1) The requirements stated in Article 13(4) shall be met until 31.12.2018.” on the packaging of medicinal products for human use as per the “Regulation on the Labelling, Package Leaflet and Tracing of Medicinal Products for Human Use”, the Braille alphabet shall be implemented until 31.12.2018 and the outer packaging of all medicinal products for human use manufactured as of 01.01.2019 shall bear Braille. Our team shall perform quality control studies of Braille on packaging materials with a Turkish Ministry of Education certified expert.

  • Quality control and approval of information in Braille on packaging materials for accuracy in Turkish by a Turkish Ministry of Education certified expert.
  • Appending an expert certificate to the Annex of the application
  • Performing the abovementioned procedures within 3 business days