Compiling product authorisation dossier(s)
The above factors determine how you go about compiling product authorisation dossier(s) and when you need to submit them to the authorities. Product authorisation dossiers require a lot of technical information on the active substance, and the other ingredients in the products, and require a risk assessment.
There is also a need to demonstrate that the product is effective and that it is labelled correctly. Doing assessment for product authorisation dossiers takes time and requires detailed information, and can be time consuming and costly.
Taking the time to plan will put you in a better position to understand what you need to do and when. We suggest you look at information from the regulators, and also check with your suppliers on active substance status and what information they can supply to you and at what cost.
PFA expertise is grounded in the know-how in applying the best scientific knowledge to dossier development, which is essential for both regulatory acceptance and cost savings.
Our understanding of scientific techniques and practical context enables us to make the best use of existing information, and to ensure that testing programmes are appropriate to the substance being registered.
We have expert knowledge of chemistry, degradation in the environment, toxicology and ecotoxicology, and thus can process dossier information correctly and with confidence.
There is quite a lot of information available from the regulators, particularly
ECHA (European Chemicals Agency
See http://echa.europa.eu/regulations/biocidal-products-regulation which is the European regulator for biocides.
national competent authorities
For example HSE (UK) see http://www.hse.gov.uk/biocides/, including clear advice on the process for product authorisation see http://www.hse.gov.uk/biocides/marketing.htm