Biocides

Biocides are regulated in the EU with Regulation (EC) No. 528/2012 (BPR). Currently there are 2 possibilities for placing all biocide products (BP) and their product types (PT 1 to PT 23) on the market:

 

Under national transitional measures

If your active substance is not included on the EU positive list of active substances yet, you can place your products on the market following national procedures. Those are not harmonised across different EU countries.

It is also important to take into consideration that since 1.9.2015 all suppliers of the active substance must be included in the Article 95 list of the product type for which the product is intended to be used and placed on the market.

Our team can help you:

    • Understand the status of your active substance
    • Understand and fulfil Article 95 obligations
    • Understand the registration possibilities available to you
    • Understand regulatory requirements and different procedures in place in individual countries of the CEE region
    • Prepare a national submission dossier in a national language or
    • Prepare the individual documents needed for submissions (application forms, labels, MSDS-es, different statements, cover letters…)

 

Under BPR/EU rules

The approval of active substances at the EU level is followed by subsequent authorisation of formulated products at the national level either via Union Authorisation procedure (UA), Mutual Recognition procedure in Sequence (MRS) or in Parallel (MRP) or by ways of Product Family Registration (PFR). An authorisation dossier can only be submitted via electronic platform R4BP 3.

Our team can assist you with:

    • Strategic advice taking your specific active substance, its status and intended uses into consideration
    • Data gap analysis (DGA), data evaluation (reliability and acceptance) as well as advice on data sharing possibilities
    • Understanding the registration possibilities available to you
    • Preparation of full registration/notification/authorisation data packages or
    • Preparation of individual documents in appropriate format and national language (application forms, labels, MSDS-es, different statements, cover letters…)
    • Assistance with the R4BP tool (creation of company account, SPC preparation in different languages, submission of applications, communication with the authority…)
    • Project management of your submission

 

STUDY GENERATION

To place your formulation on the market you must compile a dossier for active substance and formulated product. Both dossiers are a summary of all the studies generated. To help you with study generation we provide the following services:

    • Data gap analysis (DGA) which enables you to have a clear understanding of the costs involved in study generation and dossier preparation before you decide whether it makes sense to invest in your product or not
    • Coordination of study generation activities and advice on the service providers available
    • Advice with preparation of study summaries for your dossier
    • Advice on alternative options to get access to the necessary studies in cases where generation of new studies is not advisable/possible

 

DOSSIER PREPARATION

As soon as you have all the studies available the next step is to prepare a summary of the findings in the appropriate EU dossier format. Since we are not preparing dossiers ourselves we can support you by providing the following services:

    • Support with dossier preparation for active substances and formulated products providing strategic advice on dossier preparation options based on the current regulatory status of the active substance in question
    • Coordination of activities and advice with dossier preparation options and service providers available

 

NATIONAL SUBMISSIONS

Once you have your dossier for your product in place, you need to prepare your dossiers(s) for submission and evaluation at the national level. Our advice, based on more than 10 years of experience and close cooperation with the national authorities can help you:

    • Understand different EU procedures and their data requirements in place
    • Prepare your submission data package(s) in a format tailored to specific national needs.
    • Liaise with national authorities to facilitate discussions specific for your submission’s needs
    • Prepare complete submissions with all documentation needed
    • Prepare individual documents in national language(s) (application forms, labels, MSDS-es, different statements, cover letters…) and facilitate communication in local language(s)
    • Handle your submissions in multiple countries simultaneously from beginning to end with a single contact point in place for you

 

POST SUBMISSION

Success of your submissions depends very much on the activities following the submission of your application. We can offer close communications with the authorities. With the help of our expert team, able to answer the authorities’ questions and concerns quickly and in a professional way, the evaluation can be facilitated and coordinated in a more efficient way.

Services we offer:

    • Quick and professional communications with local authorities
    • Follow up on the dossier under evaluation
    • Preparation and timely submission of additional data or documents needed
    • Facilitation of communication between local authorities and applicants (and other stake holders if needed)

 

PROJECT MANAGEMENT

In cases of multiple dossier preparations for different products and in multiple countries simultaneously your regulatory team might face capacity issues. Our team can help you by appointing a single dedicated contact person/project manager (PM) for your company, who will take over all the coordination work for your ongoing registrations and will take a professional, personal approach to your needs. In, doing so you will only need to:

    • Send your data to one person in our team, once only
    • Communicate with one person only, who has an overview over all your ongoing submissions
    • Agree with the PM about the format and timelines of reporting, according to your needs