The Biocides Regulation 528/2012 (BPR) brings you to change your approaches from manufacturing to marketing your product. Many parameters must be taken into account and it can be difficult to navigate. EcoMundo gives you the keys to select a provider to help you to comply.
The role of a biocidal provider is to accompany you throughout the production process of your product, but also help you in marketing your product. To save time, it is preferable to have a single contact for all your regulatory applications regarding a biocidal product.
These steps are crucial, and will enable you save time.
Finally, following your discussions with the service provider, it will prompt you to establish an inventory of your requirements and offer you the most suitable strategies for your products, target market, and help you minimize your costs.
Sometimes it is difficult to anticipate the costs of a marketing project; however, this step is essential particularly for biocidal products given the associated costs to manufacture the product, imposed by European regulations EU No. 528/2012 (formerly DPB 98/9 EC).
Indeed, whatever the size of your business, the marketing of a biocidal product represents a significant investment. For more information, see our article onbudgeting of a biocidal product.or directly contact an expert to assess costs for your active substance (SA) and according to the product type (TP). EcoMundo experts can be reached at 01 83 64 20 54 or atcontact@ecomundo.eu
As the marketing process of a biocidal product can be long, it is best to choose a provider that offers an expanded range of services with costs adapted to your structure to avoid having to go through several providers for the same product. Thus you will gain in efficiency and save money!
The placing on the marketof a product is complex. You should choose a provider who accompanies you from the creation to the submission of your application and can technically master in its entire elements.
An expert will help you determine a scientific argument with the realization of the "data gap" as well as toxicological and ecotoxicological data (Read across,QSAR…).
Your provider will also handle the collection of relevant data such as efficiency, residue analysis, analytical data, etc. These data are essential for the development of the Authorization Dossier of your biocidal product necessary for its marketing.
Lastly, it will also take care of the administrative part which takes place in two phases. It will initially deal with creating the dossier inIUCLID format, and generate the power in order to submit a second time via theR4PB portal.
Your provider must have the ability to defend your interests in the institutions. So it is best to choose a company that can make representations on your behalf toECHAand BPC (Biocidal Product Committee) as well as from the Member State (MS) assessor who will validate your submission authorization.
The provider must be available in order to manage the exchange if asked for additional information. Better to choose a familiar and regulatory expert in various European chemical regulations to ensure proximity to the institutions. It is also your reference for your requests forAMM(marketing authorization) and for requests of mutual recognition.
It’s in your best interest to choose a provider with experience in negotiating LoAs (Letter of Access) costs for you with the "data owners".
EcoMundo is aregulatory expert provider of biocidal products.At each stage we guarantee personalized support based on your budget, your time and your privacy:
Need advice? Do not hesitate to contact our experts:contact@ecomundo.euand to read our biocide-relatedarticles
The Biocides Regulation 528/2012 (BPR) brings you to change your approaches from manufacturing to marketing your product. Many parameters must be taken into account and it can be difficult to navigate. EcoMundo gives you the keys to select a provider to help you to comply.
The role of a biocidal provider is to accompany you throughout the production process of your product, but also help you in marketing your product. To save time, it is preferable to have a single contact for all your regulatory applications regarding a biocidal product.
These steps are crucial, and will enable you save time.
Finally, following your discussions with the service provider, it will prompt you to establish an inventory of your requirements and offer you the most suitable strategies for your products, target market, and help you minimize your costs.
Sometimes it is difficult to anticipate the costs of a marketing project; however, this step is essential particularly for biocidal products given the associated costs to manufacture the product, imposed by European regulations EU No. 528/2012 (formerly DPB 98/9 EC).
Indeed, whatever the size of your business, the marketing of a biocidal product represents a significant investment. For more information, see our article onbudgeting of a biocidal product.or directly contact an expert to assess costs for your active substance (SA) and according to the product type (TP). EcoMundo experts can be reached at 01 83 64 20 54 or atcontact@ecomundo.eu
As the marketing process of a biocidal product can be long, it is best to choose a provider that offers an expanded range of services with costs adapted to your structure to avoid having to go through several providers for the same product. Thus you will gain in efficiency and save money!
The placing on the marketof a product is complex. You should choose a provider who accompanies you from the creation to the submission of your application and can technically master in its entire elements.
An expert will help you determine a scientific argument with the realization of the "data gap" as well as toxicological and ecotoxicological data (Read across,QSAR…).
Your provider will also handle the collection of relevant data such as efficiency, residue analysis, analytical data, etc. These data are essential for the development of the Authorization Dossier of your biocidal product necessary for its marketing.
Lastly, it will also take care of the administrative part which takes place in two phases. It will initially deal with creating the dossier inIUCLID format, and generate the power in order to submit a second time via theR4PB portal.
Your provider must have the ability to defend your interests in the institutions. So it is best to choose a company that can make representations on your behalf toECHAand BPC (Biocidal Product Committee) as well as from the Member State (MS) assessor who will validate your submission authorization.
The provider must be available in order to manage the exchange if asked for additional information. Better to choose a familiar and regulatory expert in various European chemical regulations to ensure proximity to the institutions. It is also your reference for your requests forAMM(marketing authorization) and for requests of mutual recognition.
It’s in your best interest to choose a provider with experience in negotiating LoAs (Letter of Access) costs for you with the "data owners".
EcoMundo is aregulatory expert provider of biocidal products.At each stage we guarantee personalized support based on your budget, your time and your privacy:
Need advice? Do not hesitate to contact our experts:contact@ecomundo.euand to read our biocide-relatedarticles