Biocide reportability

Hi,

We have a questions regarding biocide reportability;  which is can you please provide the below for the classification Biocides in the UK ?

• Legislation
• Reporting timeframe
• Form
• How it is to be reported (e.g. E2b)

Thanks

Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to pharmacovigilance regulatory legislation, guidelines and your own company procedures.

Dear PIPA Member,

Thank you for your enquiry regarding Biocide reportability.

For information, please revert to the HSE website to locate the different classifications by following the link here: https://www.hse.gov.uk/biocides/eu-bpr/product-types.htm

For legisalative guidance, please go to The Review Regulation (Regulation EU No. 1062/2014) of the EU Biocides Regulation 528/2012 (EU BPR) was published in the Official Journal of the European Union on 10 October 2014 and enters into force on 30 October 2014.

It repeals the Fifth Review Regulation (Regulation EU No. 1451/2007) of the Biocidal Products Directive 98/8/EC (BPD). Guidance is being updated following Brexit.

For the Notification of unexpected or adverse effects, please go to the following link: https://www.hse.gov.uk/biocides/eu-bpr/product-authorisation-overview.htm for further reporting information.

We do help the above helps with your enquiry.

Kind regards

PIPA

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