AMMPS AMMPS-LDAMMPS-LD EA-013, version 1.0
AMMPS-LD EA-013, version 1.0 is the official AMMPS identifier for “Ligne directrice — Mécanismes de reconnaissance « reliance » appliqués à l'enregistrement des médicaments”. AMMPS-LD EA-013, version 1.0 is the official identifier AMMPS uses for this instrument.
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- AMMPS-LD
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- AMMPS-LD EA-013, version 1.0
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- Registration
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- French
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Ligne directrice — Mécanismes de reconnaissance « reliance » appliqués à l'enregistrement des médicaments
AMMPS-LD EA-013, version 1.0, dated 10/02/2026 — the mechanisms by which the AMMPS relies on another authority's assessment when it registers a product. Nine sections and one annex: definitions and terminology, the key concepts of reliance, the reliance mechanisms with their assessment timelines, the assessment elements, the product 'sameness' test, assessment reports, the life-cycle approach, reference documents and associated documents, followed by Annexe 1, the comparative elements to be included in a 'sameness' attestation. Its title and its body are expressly about l'enregistrement des médicaments — medicines — not medical devices; it is ingested as a medicines reliance instrument, and the reliance concepts it sets out are read across to devices rather than being claimed as device guidance. It sits under AMMPS-LD RE-001 as the operational detail of the recognition routes that guideline establishes.
AMMPS-LD EA-013, version 1.0 is the official identifier AMMPS uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.