№ lp_1_2_12949
Regulatory guidance defining mandatory requirements for declaring active substances and excipients in medicinal products, including substance identification, quantitative composition, special product categories, and documentation of changes over time.
Document type: Regulatory form
Subject: Quantitative and qualitative composition of medicinal products
Version: 4.0
Valid from: 01.01.2025
Identification number: ZL000_00_032
Regulatory framework: TPLRO, HMV4
Scope: Human and veterinary medicinal products
Product category: Medicinal products
Applicable substances: Chemical, biological, herbal, homeopathic, anthroposophic, gene therapy, transplant products
Change history period: Versions 1.0–4.0
Issuing context: Marketing authorisation and regulatory submission
Price: 8 / 10 USD
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