23 August, 2017

Biocides - what to expect when you've submitted

By David Arrowsmith

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You’ve got your biocidal product authorization prepared and submitted your application to the Register for Biocidal Products (R4BP); so it’s time to relax and sit back – right? Not quite! You still have a lot to do to get your product successfully through authorization. Read on to find out some tips for surviving the validation and evaluation phases of your biocidal product authorization.

Biocide product registration: before and after

In a recent Development in Life Sciences article – 'Forging a path through the biocide product regulation'  – David Arrowsmith and Lesley Creighton, regulatory experts from Envigo, have supplied detailed advice about how to navigate your biocide through the submission process using a five-step process. Top tips include careful planning and selection of your authorization route and the Member State (MS) to act as the evaluating competent authority (eCA), as well as active engagement with your evaluating CA during pre-submission to head off downstream issues. Once you’ve submitted, however, a lot of work remains to be done.

Identify and action important emails

After you’ve submitted your application, you will receive approximately five automated emails in relation to each case where mutual recognition is being sought, along with a  couple of automated e-mails relating to the case from the eCA. This flood of automated R4BP emails will arrive within 24–48 hours of your submission. Look out for the emails containing invoices – these must be paid within 30 days of issue, and CAs will only move your case forward to the validation stage after receipt of payment.

Some CAs, such as the UK (HSE) and Finland (TUKES) to name a couple, do not issue invoices via R4BP, but via a third party. Your consultant may not receive these invoices, the invoices will be sent to the invoicing address listed within R4BP, it is therefore important to have the correct invoicing details listed within R4BP prior to submission.

Prepare for additional information requests

Commonly, CAs will ask you to supply additional information – usually in a template format –after submission. Many of these templates are available online from the CAs website– for example, France (ANSES) and Germany (BAuA) both have accessible online templates – so it is helpful to download them and start the completion process in advance of receiving the requests.  

Again, you will have seven to 30 days to submit additional information, so getting ahead can be vital. In some extreme cases, you may be able to get an extension to this time, but don’t count on it.

Manage your lines of communication carefully

You can only send emails to CAs through R4BP if you have received a communication from that particular MS; you cannot email them proactively through R4BP. 

CAs will email you separately via R4BP to request additional information. You must respond to that email but you only have one chance to respond; you cannot send another response on the same topic at a later date. Do not send off a question by reply, as you may lose the chance to send in the requested information. If you have questions regarding MS requests, submit them to that member state’s biocides helpdesk through email and not through R4BP.

The European Chemicals Agency (ECHA) has produced a good technical manual on how to use R4BP, which can provide useful guidance on monitoring your submission.

Prepare for at least a year of evaluation

Once you have paid your invoices, your case will be accepted for further processing and the next stage of submission is the validation period. The CA’s have 30 days to review your application and in some cases additional information may be requested in order to make it through this stage of the process. The maximum length of time to respond to these requests is 90 days, however in most cases a timeframe of 7 to 30 days is generally applied. Once the additional information has been provided, the case will proceed to evaluation you can settle down for at least a year of evaluation. Different MSs will approach evaluation differently, so it is worth finding out specific processes of relevance to you. For example, the UK CA (HSE) conducts an early technical sift of the submission to identify and flag areas of major concern – a useful indication of what you might need to plan for further down the line. Other MSs, like Finland (TUKES), evaluate the submission in blocks, informing you of additional needs as they arise. The length of the total evaluation process varies with the type of authorization sought: 365–545 days for National Authorization, compared with 565–755 days for Union Authorization.  Details can be found in the Biocidal Products Regulation (BPR).

Key take-away messages

  • Set up automated e-mails within R4BP
  • Act promptly on invoicing emails to ensure payment within given terms
  • Anticipate requests for additional information and start completing templates in advance
  • Watch your lines of communication and take care with emails via R4BP

For specific advice on navigating the registration process, read our white paper 'Understanding biocidal development and regulation: your route to effective regulatory approval.'

 [White paper] Understanding biocidal development and regulation

 

Category // Chemical, Biocides