EU Guidelines on Good Distribution Practice of Medicinal Products
The EU good distribution practice guidelines governing the procurement, holding, storage, and supply of medicinal products for human use. Issued under Directive 2001/83/EC (Articles 84 and 85b) and updated for the Falsified Medicines Directive (2011/62/EU), they set requirements for the quality system, the Responsible Person, temperature control, and supplier/customer qualification.
Wholesale distributors and any party in the EU medicinal-product supply chain, from manufacturer release to dispensing. Extended in principle to brokers and the distribution of active substances (separate GDP for APIs applies).
- 01A documented quality system with a designated Responsible Person
- 02Temperature-mapped storage and qualified, monitored transport
- 03Qualification of suppliers and customers to prevent falsified products entering the chain
- 04Documented handling of returns, complaints, recalls, and falsified-product suspicions
Guidelines of 5 November 2013 (correcting the March 2013 version), updated to reflect the Falsified Medicines Directive 2011/62/EU.
2013/C 343/01: frequently asked questions
Quick answers to common questions about 2013/C 343/01.
What is 2013/C 343/01?
2013/C 343/01 — EU Guidelines on Good Distribution Practice of Medicinal Products — is a guidance issued by the European Commission — EudraLex (European Union). The EU good distribution practice guidelines governing the procurement, holding, storage, and supply of medicinal products for human use. Issued under Directive 2001/83/EC (Articles 84 and 85b) and updated for the Falsified Medicines Directive (2011/62/EU), they set requirements for the quality system, the Responsible Person, temperature control, and supplier/customer qualification.
Who does 2013/C 343/01 apply to?
Wholesale distributors and any party in the EU medicinal-product supply chain, from manufacturer release to dispensing. Extended in principle to brokers and the distribution of active substances (separate GDP for APIs applies).
What are the key requirements of 2013/C 343/01?
EC 2013/C 343/01 requires, among other things: A documented quality system with a designated Responsible Person; Temperature-mapped storage and qualified, monitored transport; Qualification of suppliers and customers to prevent falsified products entering the chain; Documented handling of returns, complaints, recalls, and falsified-product suspicions.
When was 2013/C 343/01 last updated?
The current version of 2013/C 343/01 dates from November 2013. Guidelines of 5 November 2013 (correcting the March 2013 version), updated to reflect the Falsified Medicines Directive 2011/62/EU.
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