SERIALISATION

  • SERIALISATION 1
  • SERIALISATION 2
Product Description

9 February 2019 saw the entry into force in Poland of Commission Delegated Regulation (EU) 2016/161 which requires medicinal product manufacturers to use certain safety features on their products. This posed a serious challenge to pharmaceutical and contract manufacturers who had to bring their manufacturing processes and their technical and computer infrastructure in line with the new regulatory standards.

Directive 2011/62/EU (“Anti-Counterfeiting Directive”) introduced new standards under which pharmaceutical manufacturers must make sure that individual packs bear anti-counterfeiting safety features. While these regulations apply exclusively to prescription drugs, there are some exceptions where safety features may be additionally required for other products, including over-the-counter drugs.

The anti-counterfeiting law requires that individual packs cannot be opened unless they are physically interfered with (ATD – anti-tampering device) and that ea...

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Prespack Sp. z.o.o.

  • PL
  • 2021
    On CPHI since
  • 1
    Certificates
  • 50 - 99
    Employees
Company types
Contract Service
Primary activities
Contract Manufacturer
View company profile
Categories
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Specifications
  • Details
    Contract serialization within an integrated project involving production, serialization data management, data communication to/from EUHUB, and deserialization. The serialization process ensures full product identification throughout the distribution chain and protects the product from counterfeiting. Prespack’s serialization services include:
    - Printing and verification of unique identifiers on each individual package.
    - Sealing packages with tamper-evident labels (ATD).

More specifications Fewer specifications

Prespack Sp. z.o.o.

  • PL
  • 2021
    On CPHI since
  • 1
    Certificates
  • 50 - 99
    Employees
Company types
Contract Service
Primary activities
Contract Manufacturer
View company profile

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