

It elaborates on the issue raised in the Guideline on pharmaceutical development of medicines for paediatric use. V: applicable to veterinary medicinal products.


These questions and answers address a number of questions that have been brought to the attention of the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. Stability - Stability issues of pharmaceutical bulk products use in manufacture of the finished product.Stability - Reduced design in stability studies.Stability - Generics versus the innovator product.Stability - Endotoxin testing and sterility testing at the end of shelf-life.Stability - Declaration of storage conditions.Specific types of product - Veterinary medicinal products.Specific types of product - Quality of investigational medicinal products.Specific types of product - Orally inhaled products.Specific types of product - Needle safety systems.Specific types of product - Need for in vitro dissolution studies with alcohol for modified-release oral products including opioid drug products.Specific types of product - Graduation of measuring devices for liquid dosage forms - Updated Nov.Specific type of products – Dry product inhalers.Setting specifications for impurities in veterinary medicinal products.Replacement/removal of titanium dioxide (TiO2) in medicines.
#Underground pure 6 extreme formula free

Definition of ‘active substance’ in relation to mixtures.Appearance of tablets of different strengths.Acceptability of two different appearances (shape, dimensions, colour) for a single strength tablet in a single Marketing Authorisation.Administration of oral immediate release medicinal products through enteral feeding tubes NEW December 2018.
