Draft GUIDELINE ON PRODUCT INFORMATION AND LABELLING

MCAZ-EVR-GL-17 Rev 01_July 2026 Guideline on General Requirements for Bioequivalence

MCAZ-EVR-GL-30_Rev 01_July 2026_Guideline on the submission of applications for registration in common technical document (CTD) format

MCAZ-EVR-GL06 Rev 2_April 2026 GUIDELINE ON RENEWAL OF PRODUCT REGISTRATIONS

MCAZ-EVR-GL-02 Rev 02_April 2026 Guideline for Good Review Practices (GRevP)

EVR-GL03_GUIDELINE FOR SUBMITTING APPLICATIONS FOR VARIATIONS TO REGISTERED MEDICINES

EVR_GL-29_Guideline on the requirements for demonstrating therapeutic equivalence for orally inhaled products for asthma and COPD

EVR_GL-28_Quality guidelines on the sterilisation of the medicinal product, active substance, excipient, and primary container

EVR GL21_Guidelines for highly purified synthetic peptide medicines

EVR GL20_Guideline on the submission of information for Module 1 of the dossier

EVR GL19_Guideline on structure and content of clinical study reports

EVR GL18_Guideline on biopharmaceutics classification system-based biowaivers

EVR GL16_Guideline on bioequivalence for immediate-release solid oral dosage forms

EVR GL15_Guideline on bioanalytical method validation and stidy sample analysis

EVR GL27_Quality guidelines for medicinal products used with medical devices