EU Directive 2001/83/EC - Community Code Relating to Medicinal Products for Human Use

What it says

This Directive is the core piece of EU legislation governing medicinal products for human use, covering marketing authorisation, manufacturing and import, wholesale distribution, labelling, advertising and pharmacovigilance, and is the legal source from which the detailed EU GMP guidance draws its authority.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Manufacturers in the EU need a manufacturing authorisation, and the Directive sets out the obligations attached to it, including having a Qualified Person available.
• It links the marketing authorisation to the manufacturing site, so what is described in the authorisation has to match what is done on site.
• The detailed GMP rules are set out in the implementing GMP principles and the EU GMP Guide, with this Directive providing the legal basis.

What inspectors look for

• Whether manufacturing operations are consistent with the manufacturing authorisation and the marketing authorisation dossier.
• Whether a Qualified Person is available and performing the certification duties assigned to the role.
• Whether starting material, including active substance, suppliers are qualified as the legislation and guidance expect.

Related regulations