What EU Good Distribution Practice (GDP) Guidelines 2013 - European Commission Guideline 2013/C 343/01 requires
The European Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01), published in the Official Journal of the EU on 23 November 2013, set binding quality standards for the wholesale distribution of authorised medicinal products within the European Economic Area. The GDP Guidelines implement Article 84 of Directive 2001/83/EC and require wholesale distributors to hold a Wholesale Distribution Authorisation (WDA), operate a quality system based on quality risk management principles, and maintain the storage and transport conditions required by the marketing authorisation. The 2013 Guidelines replaced the 1994 GDP guidelines and added new chapters on transportation (Chapter 9) and brokers (Chapter 10), reflecting the requirements of Directive 2011/62/EU (Falsified Medicines Directive) to combat counterfeit and falsified medicinal products in the supply chain.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Commission - Directorate-General for Health and Food Safety (DG SANTE); Article 84 of Directive 2001/83/EC of the European Parliament and of the Council; Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01) · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52013XC1123%2801%29
SHA-256 integrity: 37580a4f5af65257d0ed39445a5b51d31c0454fd5f1c39175766bb15c102e748
Primary Citations — 6 traced to source
- {"source":"European Commission - Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01), Official Journal of the European Union C 343, 23.11.2013, pp. 1-14","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52013XC1123%2801%29","relevant_sections":"Chapter 1 (Quality Management: quality system, Responsible Person, management review); Chapter 3 (Premises and Equipment: temperature mapping, monitoring, qualification); Chapter 5 (Operations: sourcing, supply, supplier qualification); Chapter 6 (Complaints, Returns, Suspected Falsified Medicinal Products, Recalls); Chapter 9 (Transportation: temperature-controlled transport, validation, monitoring); Chapter 10 (Specific Provisions for Brokers: registration, compliance requirements)"}
- {"source":"European Commission - DG SANTE: Good Distribution Practice of Medicinal Products for Human Use - Official Guidance Page","url":"https://health.ec.europa.eu/medicinal-products/good-distribution-practice_en","relevant_sections":"Current GDP guidelines text, question-and-answer documents (Q&A on GDP guidelines), WDA requirements, guidance on temperature-controlled transportation, and FMD interface with GDP operations"}
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