CRED SMPC 2024

17/09/2024

Outer Packaging

Braille

•

As per requirements of Article 56 of 2001/83/EU

• EU guideline highly recommends Marburg Medium character

set

•

Other character sets per national guidance

•

Braille not required for products used by healthcare

professional only

• For medicinal products authorised only in a single strength,

only the invented name in Braille is acceptable

• No need to include pharmaceutical form as part of the Braille, if there is only one

•

Stickers (‘Adhesive Braille Labels’) are allowed

The Organisation for Professionals in Regulatory Affairs

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Outer Packaging

Unique identifier

• 2D Barcode - Directive (2011/62/EU) (FMD)

• Unique identifier in form of a 2D matrix (barcode) and an anti-tamper device (ATD)

• The Unique Identifier comprises of Product Code (PC), Serial Number (SN), batch number, expiry date and National reimbursement number, if required by the member state

• Verifies the authenticity of the medicinal product

The Organisation for Professionals in Regulatory Affairs

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