Biocides

Biocides are regulated in the EU with Regulation (EC) No. 528/2012 (BPR) and need to be authorized before they can be placed on the market. At the moment there are two possibilities for placing biocide products (BP) and their product types (PT 1 to PT 23) on the market:

  • Under transitional measures
  • Under BPR/EU rules

We offer the following services:

Submissions under transitional measures

Submissions under BPR/EU rules

Study generation

Dossier preparation

Post submission

SPC & label preparation

Project management

Submissions under 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.

We offer the following services:

  • Overview on the status of your active substance
  • Compliance with the Article 95 obligations
  • Help you understand the registration possibilities available to you
  • Provide you with regulatory requirements and different procedures in place in individual countries of the CEE region
  • Prepare complete submission dossiers in a national language and a format tailored to specific national needs
  • Prepare individual documents needed for submissions (application forms, labels, MSDS-es, different statements, cover letters…)
  • Handle your submissions in multiple countries simultaneously from beginning to end with a single contact point in place for you

Submissions under BPR/EU rules

The approval of active substances at the EU level is followed by subsequent authorisation of formulated products - either via application for Union Authorisation procedure (UA) or applications for national authorisation via Mutual Recognition procedure in Sequence (MRS) or in Parallel (MRP). Applications for Union authorisation shall be submitted to the European Chemical Agency. The Applications for national authorisation in a Member State shall be submitted to the competent authority of that Member State. An authorisation may be granted for a maximum period of 10 years for single biocidal product or a biocidal product family. An authorisation dossier can only be submitted via electronic platform R4BP.

We offer the following services:

  • 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
  • Understand different EU procedures available to you
  • Preparation of complete submissions with all documentation needed
  • Preparation of individual documents in appropriate format and national language (application forms, labels, MSDS-es, different statements, cover letters…)
  • Assistance with the R4BP tool and/or it’s management (creation of company account, SPC preparation in different languages, submission of applications, communication with the authority…)
  • Handle your submissions in multiple countries simultaneously from beginning to end with a single contact point in place for you

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. We offer 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

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.

We offer the following services:

  • 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)

SPC & label preparation

Summary of Product Characteristics (SPC) is an integral part of authorisation decision and as part of the authorization procedure, you will be invited to provide a high quality national SPC versions within a short deadline.

National version of SPC does not foresee only a professional linguistic quality translation but also a thorough regulatory and expert knowledge in the area of biocides. Our experts are native speakers who have extensive experience with preparation of SPCs and product labels in a number of EU official languages and adjusting their content and terminology to national specific requirements and guidelines in place.

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