Harmonisation of Laws Relating to the Application of GLP
The EU Directive requiring Member States to apply the OECD Principles of GLP when conducting nonclinical safety tests on chemical products, and to verify compliance. Together with Directive 2004/9/EC (inspection and verification) it embeds GLP and Mutual Acceptance of Data into EU law.
Nonclinical safety testing of chemical products (including medicinal, cosmetic, and industrial substances) within the EU. Complemented by 2004/9/EC on GLP inspection.
- 01Apply OECD GLP principles to in-scope nonclinical safety studies
- 02Undergo national GLP inspection and study audit under Directive 2004/9/EC
- 03Declare GLP compliance status in study reports
Codified the earlier Directive 87/18/EEC; remains the EU legal basis for GLP alongside 2004/9/EC.
Directive 2004/10/EC: frequently asked questions
Quick answers to common questions about Directive 2004/10/EC.
What is Directive 2004/10/EC?
Directive 2004/10/EC — Harmonisation of Laws Relating to the Application of GLP — is a regulation issued by the European Commission — EudraLex (European Union). The EU Directive requiring Member States to apply the OECD Principles of GLP when conducting nonclinical safety tests on chemical products, and to verify compliance. Together with Directive 2004/9/EC (inspection and verification) it embeds GLP and Mutual Acceptance of Data into EU law.
Who does Directive 2004/10/EC apply to?
Nonclinical safety testing of chemical products (including medicinal, cosmetic, and industrial substances) within the EU. Complemented by 2004/9/EC on GLP inspection.
What are the key requirements of Directive 2004/10/EC?
EC Directive 2004/10/EC requires, among other things: Apply OECD GLP principles to in-scope nonclinical safety studies; Undergo national GLP inspection and study audit under Directive 2004/9/EC; Declare GLP compliance status in study reports.
When was Directive 2004/10/EC last updated?
The current version of Directive 2004/10/EC dates from February 2004. Codified the earlier Directive 87/18/EEC; remains the EU legal basis for GLP alongside 2004/9/EC.
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Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
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When Directive 2004/10/EC — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.