Task Force & Consortium Management
spectra’s team has long-lasting experience with management and regulatory & technical support of task forces for active substances as well as product consortia and supports you through different stages.
Task forces for biocidal active substances
Under the BPD (Biocidal Products Directive, Directive 98/8/EC), numerous task forces for supporting biocidal active substances in the review programme have been established. For the 1st to 4th priority lists, draft Competent Authority Reports (dCARs) were due already by 31/12/2015 to 31/12/2019. For the 5th and 6th priority lists, dCARs are to be submitted to ECHA by 31/12/2020 and 31/12/2022, respectively. For various reasons, numerous dossiers got stuck in the evaluation process and the Biocidal Product Committee (BPC) has not issued an opinion on approval/non-approval yet.
spectra is fairly successful in awaking backlog dossiers from deep sleep. We well know the levers to make the active dossiers fly again:
- regulatory lever: we have good contacts to European Authorities and ECHA and can quickly clarify the status quo of the dCAR
- technical lever: we work – either from scratch or update – on dossier parts for which expert knowledge is needed such as (eco)toxicological data package, risk assessments, ED assessment
- capacity lever: we can support RMS with preparation of ECHA meetings or update of dCAR within the short timeframes after working group or BPC meetings
spectra is also prepared to
- take over management of existing task forces for active substances established under the BPD (Biocidal Products Directive, Directive 98/8/EC)
- establish new task forces for active substances under the BPR (Biocidal Products Regulation, Regulation EU No 528/2012)
- support companies that are a member of an active substance task force or intend to join a task force
Consortia for biocidal products
The road to Union authorisation or national authorisation with or without mutual recognition can be long and winding. Filing a dossier requires dedicated regulatory and technical professionals, internal capacities and considerable budgets for consultants, product testing, legal fees and meetings with authorities and/or ECHA. Why go alone then? In a product consortium companies work together to join forces with respect to expertise and resources while at the same time they all may profit from cost savings. Often underestimated in the discussion: A consistent and harmonised assessment under the umbrella of a consortium dossier is another positive side effect.
Call of interest and expression of interest
From time to time, spectra publishes on the website calls of interest for active substance(s) and product type (PT) combinations for which we intend to set up a product consortium.
In parallel, spectra welcomes receiving expressions of interest for future product consortia from our clients which we will take up and transfer into calls of interest. A convenient timeframe is about 2-3 years before the date of approval of an active substance.
In this phase, spectra aims at bringing together interested parties and joining forces in the complex authorisation process of biocidal products.
Once interested parties have agreed to move forward, spectra will elaborate on a conceivable dossier strategy. This may either be a concept for one or several biocidal product families or single biocidal products. Alternatively, a core dossier concept may be proposed from where the companies prepare their individual product dossiers. Involving a legal advisor and drafting a consortium agreement is also part of the pre-consortium phase. spectra sees its role as a mediator between (competitive) companies having the same principal goals. At this early project stage, each company can figure out whether and to which extend they could profit from the product consortium.
The management part of the consortium phase may include
- setting up of steering and technical committees
- organisation of consortium meetings and leading of decision making processes
- data sharing and LoA negotiations (e.g. with active substance suppliers or owners of vertebrate studies)
The technical part of the consortium phase is not that different from the preparatory phase of a “normal” dossier for a biocidal product family or single biocidal product and may include:
- gathering of product information from consortium members
- final agreement on the dossier concept (e.g. biocidal product family/families, single biocidal product(s), core dossier(s))
- thorough data gap analysis
- elaboration of integrated testing strategy and initiation of new studies
- preparation of dossier and final submission on behalf of consortium
Individual member support
spectra supports you with any application for same biocidal product (family), be it for Union authorisation or national authorisation with mutual recognition.
In case you join a product consortium which is based on a core dossier, spectra will derive independent dossiers customised to each consortium member’s needs.