Same biocidal product authorisation
Applications can be made to HSE for national or simplified authorisations for biocidal products and biocidal product families in Great Britain (GB) that are identical to another single biocidal product or biocidal product family which has already been authorised, or is currently under assessment, under the GB Biocidal Products Regulation (GB BPR) – this is known as a same biocidal product authorisation.
Same biocidal product applications can be made for:
- single biocidal products that are identical to:
- a single reference biocidal product
- a single product which is part of a reference biocidal product family
- biocidal product families that are identical to:
- a reference biocidal product family
- part of a reference biocidal product family
How to apply
The prospective authorisation holder or company acting on their behalf must submit, 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 letter of access to a dossier held by HSE, that satisfies the requirements of Annex II and Annex III of GB BPR – this dossier should include the data that supported the authorisation of the reference product / product family
- Summary of Product Characteristics (SPC) using the following templates as appropriate:
- details of the proposed differences between the same product and related reference product, and evidence that the products are identical on all other aspects
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 authorisation holder must be established in the UK.
- All biocidal product names must be unique – please check list of GB authorised productsto determine if your proposed product name has already been used.
- Letters of Access must relate to data held by HSE – you should talk to your active substance supplier and the authorisation holder of the reference product / product family 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 check (validate) that you have submitted all of the required information in the correct format – this will take approximately 30 days from the payment of the initial estimated fee” and will include a check that the proposed same biocidal product / biocidal product family is identical to the reference product / product family with the exception of information which can be the subject of an administrative change (eg different authorisation holder or different product manufacturer)
- make a decision as to whether the same biocidal product / biocidal product family can be authorised in GB – this will take approximately 60 days from validating the application or, where applicable, from the decision date concerning the reference product
- 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 authorisation being cancelled
Product authorisation decision
- send the applicant a copy of the draft 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 (depending on your agreement with the authorisation holder of the reference product you may not receive a PAR)
- take into account the applicant’s comments, where relevant
- assign an authorisation number to the biocidal product / biocidal product family which will be different to that of the reference product.
- issue a signed Certificate of Authorisation
- examine the draft Product Assessment Report (PAR), where applicable, and draft Certificate of Authorisation and return them to HSE (with comments if necessary) to indicate your agreement with the authorisation conditions
- wait until the signed Certificate of Authorisation has been issued and ensure you comply with the conditions and restrictions in the authorisation before making the product available on the market in GB
- ensure you remove from the distribution chain any existing stocks that do not meet the new conditions and restrictions of the authorisation within 180 days of the authorisation being issued – if you were previously allowed to supply the product underother national law in GB eg COPR
- ensure you comply with any deadlines associated with the authorisation, such as for any post authorisation data requirements or your authorisation may be cancelled
- note your 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 – note that:
- same biocidal products / biocidal product families may be changed or cancelled independently to the reference product / product family
- during the assessment of proposed changes to products that are linked by same biocidal product authorisation, HSE may consider it appropriate to amend or cancel the authorisation of other linked products
HSE will not issue an authorisation where an application does not meet the required standards.
An application can be rejected at any stage if the relevant fees or requested information / data are not submitted or are unacceptable.