Get the free Guide for filling out important fields of the SUE Report Form - infarmed

Ref. Ares(2015)4460770 21/10/2015 SUE form A General instructions for completing notification of SUE by Responsible Person or Distributor to Competent Authority Form A is designed to be filled in

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People Also Ask about

What is the word cosmetics derived from?

The word cosmetics is derived from the Greek κοσμητικὴ τέχνη (kosmetikē tekhnē), meaning "technique of dress and ornament", from κοσμητικός (kosmētikos), "skilled in ordering or arranging" and that from κόσμος (kosmos), meaning "order" and "ornament".

What are undesirable effects of cosmetics?

An undesirable effect is an adverse reaction to a cosmetic product under normal or foreseeable conditions of use. Examples of undesirable effects include irritant and allergic effects, sensitivity to light and itching.

What does sue in cosmetic signify?

• A serious undesirable effect (SUE), on the other hand, is "an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies or an immediate vital risk or death."

What is a serious undesirable effect?

Serious undesirable effects are defined as “undesirable effects which result in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death”6. Taking into account the definition of an SUE, the word "serious" is not synonymous with severe.

What is temporary or permanent functional incapacity?

Effects that result in interruption of work or sick leave are examples of temporary functional incapacity. Changes in appearance that significantly affect quality of life, such as strong allergic reaction on the face, can also be considered serious. Effects of permanent functional incapacity are permanent.

What is the description of cosmetics?

Cosmetics are pharmaceutical products that are used for improving skin appearance and body odor. These products are available in various forms, ranging from lotions, creams, powders, and so forth. Cosmetics are used for cleansing, protecting, and moisturizing the skin.

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