Change or cancel a biocidal product authorisation

3. How HSE will deal with your change application

After receiving your application we will:

1. conduct a brief initial check of the information to confirm that it meets the requirements for the application type
2. estimate how much it may cost (‘initial estimated fee’) to process the application based on the information provided
3. 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
4. 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’
5. evaluate the application according to the approximate time frame for the relevant category of change
6. decide if the requested change can be authorised in GB
7. 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 change being rejected

We may ask you to provide further information at various stages of the process. If we do, the timeframes given will be suspended.

We may reject your application if:

• the information you provide is not satisfactory
• you fail to provide the information within the specified deadline

If the biocidal product or biocidal product family is supplied in the form of a bait station or other physical device, we may ask you for a sample to inform the risk assessment.

Decision on whether the change can be authorised

When we have evaluated your application, we will decide if we can authorise the change.

Successful applications

HSE will:

• send you a copy of the updated draft authorisation conditions HSE intends to set for the product – these are set out in an updated draft Product Assessment Report (PAR) and updated draft Certificate of Authorisation
• take your comments into account, where relevant
• issue a new signed Certificate of Authorisation that will replace the one previously issued

You should:

• 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 updated 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 'amended' 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 authorisation being issued
• ensure you comply with any deadlines associated with the authorisation, such as for any post authorisation data requirements
• 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 make additional amendments or cancel your authorisation

Unsuccessful applications

HSE will not issue an amended authorisation if the application does not meet the required standards.

You may have the opportunity to modify or update your application to make it acceptable where that’s appropriate.

Rejecting applications

We can reject an application at any stage if you do not:

• pay the relevant fees
• submit the requested information or data, or they’re unacceptable