2013/C 343/01 - Good distribution practices for medical products

The official mark of the Good Distribution Practice (GDP) legislation

• European Commission Guidelines 2013 November 5 on good distribution practices (GDP) for medicinal products for human use (2013/C 343/01).

Overview of Good Distribution Practices (GPP).

Good distribution practice (GPP) defines the requirements that wholesale distributors must meet in order to ensure the quality of medicines and prevent falsified medicines from entering the legitimate supply chain. This includes purchasing, storing, and transporting medicinal products, ensuring that the products reach the right recipients within an acceptable period of time. Medicines are a special product, the improper storage, transportation, and use of which are dangerous to health and life, so its path from the manufacturer to the consumer must be strictly controlled to prevent low-quality drugs from entering the market.

Adherence to the system developed according to the recommendations of good distribution practices creates added value for the company:

• All major milestones and significant changes in distribution processes are documented and, where appropriate, validated;
• The product remains of high quality and reliability and does not enter the illicit supply chain during storage and transportation of the product;
• The operation of the change control system is ensured;
• Medicines are purchased, stored, supplied or exported in compliance with GPP requirements;
• Managers' responsibilities are clearly defined;
• Delivery of products to recipients within an acceptable period is ensured;
• Traceability of records;
• Deviations and risks are managed.

Customer benefits of Good Distribution Practices (GPP)

Customers of companies that comply with the GPP requirements receive the following benefits:

• Confidence in the manufacturer and service provider is increased;
• Compliance with legal requirements is ensured;
• Quality services and products;
• Transparency and traceability;
• Competitive advantage when offering or supplying products to the European Union or other countries.

Which sectors are covered by Good Distribution Practice (GPP)

The service is intended for the part of the pharmaceutical sector that includes wholesale distribution:

• For transport and logistics companies transporting medicines,
• For companies engaged in mediation of medicinal products,
• For holders of wholesale distribution licenses and
• For other persons engaged in the activity of wholesale distribution.