Renew an existing product authorisation
Biocidal products / biocidal product families with national authorisations granted under the GB Biocidal Products Regulation (GB BPR) in Great Britain (GB) will expire on the date specified on their Certificate of Authorisation unless renewed.
If you are seeking the renewal of a national authorisation for one or more product types, you must submit a renewal application to HSE at least 550 days before the expiry date of the authorisation.
Biocidal products / biocidal product families with simplified authorisations granted under GB BPR cannot be renewed and will expire on the date specified on their Certificate of Authorisation.
A biocidal product / biocidal product family with an expired authorisation cannot be made available on the GB market beyond its expiry date. Making available on the market means any supply of a biocidal product, whether in
- manufacturer to distributor
- distributor to retail store
- retail store to user
How to apply
The authorisation holder or company acting on their behalf must submit, in English, a completed application form to [email protected] – companies may wish to mark emails as appropriate eg confidential. Please note that your application form may be returned if it is incomplete.
Only the application form should be submitted by email. All other relevant documentation / data must be submitted via the HSE Secure File Sharing Service, including:
- a dossier in ICULID format, containing all relevant data that has been generated since the initial authorisation or, as appropriate, previous renewal
- a draft Product Assessment Report (PAR) of whether the conclusions of the initial or previous assessments of the biocidal product / biocidal product family remain valid and any supporting information
- reference list of studies
All documents / attachments should be included within your IUCLID dossier.
Using the HSE Secure File Sharing Service
- Once we have received and processed your application form, you will be sent a link to upload the files associated with the relevant application – please do not use the link to upload files related to other applications.
- Links will be sent out Monday – Friday and are valid for 5 working days – if the link expires before you are able to upload your files, please email [email protected] to request a new link.
- Please ensure you comply with the terms and conditions of using the HSE Secure File Sharing Service – these will be included in the email alongside the link.
- Please check the spam settings on your email account to ensure our emails are not going to your junk folder.
Things to note
- The purpose of a renewal is to renew the existing authorisation conditions.
- Where new data or information shows that the existing authorisation no longer meets the conditions of Article 19, the conditions of authorisation may be amended by HSE.
- Renewals cannot be used to make changes to the authorisation conditions at the request of the authorisation holder, except where the changes are intended to ensure the authorisation continues to meet the conditions of Article 19 (eg the product is sufficiently effective and has no unacceptable effects on humans, animals or the environment).
- Letters of Access relating to data submitted for the initial or previous assessments remain valid and do not need to be resubmitted.
- Where Letters of Access are required for newly submitted data, these must relate to data held by HSE – you should talk to your active substance supplier to ensure they have submitted the data to HSE.
What HSE will do
After receiving your application HSE will:
- conduct a brief initial check of the information to confirm that it meets the requirements for the application type
- estimate how much it may cost (“initial estimated fee”) to process the application based on the information provided
- issue an invoice to the applicant which must be paid within 30 days of the date of the invoice – failure to pay the requested fees will result in your application being rejected
- accept the application once the initial estimated fee has been paid and determine, based on the available information, whether a full evaluation is necessary – this will take approximately 90 days from the payment of the “initial estimated fee”
- review the conclusions of the initial assessment or, as appropriate, the previous renewal alongside any newly available data or information – this will take approximately:
- 365 days where a full evaluation is required
- 180 days where a “light” evaluation is required
- extend the expiry date of the authorisation if, for reasons beyond the control of the authorisation holder, no decision is taken on the renewal of the authorisation before it is due to expire – the expiry date will only be extended for the period necessary to complete the evaluation
- take into consideration the results of a new comparative assessment carried out in accordance with Article 23, if applicable
- make a decision as to whether the biocidal product / biocidal product family authorisation can be renewed in GB
- issue an invoice for a “top up” fee if the cost of evaluating the application has gone beyond the initial estimated fee, which must be paid within 30 days of the date of the invoice – failure to pay the requested fees will result in your renewal being rejected
When the evaluation of a renewal application is completed, a decision will be made as to whether the biocidal product / biocidal product family can be renewed.
- send the applicant a copy of the draft renewed authorisation conditions HSE intends to set for the product – these are set out in a draft Product Assessment Report (PAR) and draft Certificate of Authorisation
- take into account the applicant’s comments, where relevant
- issue a signed Certificate of Authorisation which will replace the one previously issued
- examine the draft Product Assessment Report (PAR) and draft Certificate of Authorisation and return them to HSE (with comments if necessary) to indicate your agreement with the renewed authorisation conditions
- wait until the signed Certificate of Authorisation has been issued and ensure you comply with the conditions and restrictions in the renewed authorisation before making new stocks of the product available on the market in GB
- ensure you remove from the distribution chain any existing stocks (products already labelled under the old conditions of authorisation) that do not meet the new conditions and restrictions of the authorisation within 180 days of the renewed authorisation being issued
- ensure you comply with any deadlines associated with the renewed authorisation, such as for any post authorisation data requirements or your authorisation may be cancelled
- note your renewed authorisation expiry date - the authorisation will expire on the date shown unless the authorisation holder submits a valid application for renewal at least 550 days before the expiry date
- ensure you comply with other requirements of GB BPR which include (but are not limited to):
- packaging and labelling requirements (Article 69)
- advertising requirements (Article 72)
- record keeping requirements (Article 68)
- notification of unexpected or adverse effects (Article 47)
- ensure you comply with general chemical and product safety law which continues to operate such as:
- GB Classification, Labelling and Packaging of Substances and Mixtures (GB CLP) Regulation
- General Product Safety (GPS) Regulations
- contact HSE if you intend to amend or cancel your authorisation
HSE will not renew an authorisation where the conditions in Article 19 (eg the product is sufficiently effective and has no unacceptable effects on humans, animals or the environment) are no longer met.
The applicant may have the opportunity to modify / update their application to make it acceptable where that is appropriate.
An application can be rejected at any stage if the relevant fees or requested information / data are not submitted or are unacceptable.