448 documents
Evaluation Manual v. 2020-2
Evaluation Manual version 2020-2 is published in April 2020. The Evaluation Manual is a technical instructions and gives ...
8. Efficacy
8. Efficacy EU part EM2.4
Chronologic overview RM PPP
Preparations of disinfectants for hand sanitisers
I want to put a disinfectant on the market that complies with the WHO formulation, but I have several other co-formulants in my product. Is this allowed?
The exemption exclusively covers products that contain only the active substances specified in the WHO formulations. The ...
Who is covered by the term ‘professionals in the healthcare sector’?
‘Professionals in the healthcare sector’ covers everyone who works in the healthcare sector. In the context of disinfection, this ...
I want to place a disinfectant on the market with a concentration of alcohol or other active substance that deviates from the exemption for WHO formulation and the exemption for pharmacy products. Is this allowed?
No, the exemption for WHO formulations only covers disinfectants that contain the active substances in the concentrations ...
I want to buy disinfectants, but how do I know if it is a legal product?
You may purchase and use the disinfectants that are authorised for the intended use by intended user. The Ctgb keeps track of ...
I want to use the exemptions to sell a disinfectant or make it available to private persons. Is this allowed?
No, the exemptions are intended to meet the most urgent need, which is use by healthcare professionals. If other sectors are ...