Medical Auxiliary Products

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Auxiliary Medicinal Products in Clinical Trials - Public Health

https://health.ec.europa.eu/document/download/47ad006a-6ad4-488d-bb51-ab91d11e2871_en

(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a …

Auxiliary Medicinal Products in EU Clinical Trials

https://ispe.org/pharmaceutical-engineering/ispeak/auxiliary-medicinal-products-eu-clinical-trials

Auxiliary medicinal products should not include any medication unrelated to the clinical trial and not relevant for the design of the clinical trial (concomitant …

New Definition for Auxiliary Medicinal Products (AMPs)

https://www.gmp-compliance.org/gmp-news/new-definition-for-auxiliary-medicinal-products-amps

So far, Regulation (EU) No 536/2014 Article 2 (8) defines an AMP as "a medicinal product used for the needs of a clinical trial as described in the protocol, but not …

Auxiliary Medicinal Product Dossier (AxMPD) | Investigators | The ...

https://english.ccmo.nl/investigators/clinical-trials-with-medicinal-products-ctr/preparation-ctr/research-dossier-part-i/auxiliary-medicinal-product-dossier

Auxiliary medicinal product means a medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product. Examples …

Definition of Investigational Medicinal Products (IMPs) and …

https://health.ec.europa.eu/system/files/2016-11/gl_2_consult_0.pdf

Medicinal products that do not have a marketing authorisation, but prepared in accordance with a magistral formula, i.e. prepared in a pharmacy in accordance with a medical …

Investigational Medicinal Product Labelling | PPD Inc

https://www.ppd.com/blog/eu-clinical-trial-regulation-investigational-medicinal-product-labelling/

AMPs are defined by CTR as “ medicinal products used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product.” …

HSA | Investigational and auxiliary products

https://www.hsa.gov.sg/clinical-trials/conducting/investigational-auxiliary-products

What are investigational products and auxiliary products An investigational product (IP) is defined as a therapeutic product, Class 2 cell, tissue and gene therapy product (CTGTP), …

Medicinal Product Identification | FDA

https://www.fda.gov/industry/fda-data-standards-advisory-board/medicinal-product-identification

Medicinal Product Identification | FDA Medicinal Product Identification ISO 11615 Medicinal Product Identification (MPID) establishes definitions and concepts and …

Medicinal product | European Medicines Agency

https://www.ema.europa.eu/en/glossary/medicinal-product

Medicinal product | European Medicines Agency Medicinal product A substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to …