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- Plano de Controlo de Qualidade e Conformidade Legal de SUPLEMENTOS ALIMENTARES: ” Formação muito útil para o desempenho das minhas funções “
- MHRA Registration of medical devices
- The Use of Data in Public Health. Understanding the Potential for Artificial Intelligence in Medicine
- UK Government confirms indefinite recognition of CE marked medical devices
- Methodological Principles for the Assessment of Section 5.1 of the Summary of Product Characteristics
- Good manufacturing practice (GMP) Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22)
- PIC/S PE 009-18 – Guide to GMP for Medicinal Products | Part I
- EMA Updates Information Page on Bioequivalence Guidelines
SCOPE AND ORGANISATION
The M4Q(R2) guideline establishes the location and structure of quality information for registration applications of all medicinal products for human use. It supports various submission types, including those referring to or consisting of master files, and applies to both initial marketing authorisation and post-approval submissions. This guideline is structured to be flexible to accommodate all types of medicinal products and their components.