f

Industry

Frequently Asked Questions

If placing the product on the market in Great Britain (England, Wales and Scotland) only – then you need only submit an SDS (in pdf format) to sds.npis@nhs.net.

If placing the product on the market in Northern Ireland, compliance with EU legislation is mandatory and safety information must be submitted in the harmonised Annex VIII format. For more details click here

A. No. An SDS is only acceptable for Great Britain (England, Wales and Scotland). For products placed on the market in Northern Ireland, EU CLP rules must be followed. Click here for further advice.

A. No. Information submitted to MySDS does not automatically mean that NPIS have been notified. To ensure your products are registered with the NPIS, please submit directly to sds.npis@nhs.net.

A. SDS can be submitted via email to sds.npis@nhs.net. Once received by the NPIS you will receive acknowledgement from one of the specialists in poisons information who will be your named contact with us.

A. SDS should ideally be in pdf format, though Word format is also acceptable. USB drives and CDs can be sent by post to National Poisons Information Service (Birmingham Unit), City Hospital, Dudley Road, Birmingham, B18 7QH.

A. At the present time, there is no charge.

A. You will receive an acknowledgement of receipt from your named contact within NPIS by email. Should you require an official certificate of notification, an administrative charge will apply. Please contact sds.npis@nhs.net for further details.

A. No. The ‘certificate of notification’ only confirms receipt of an SDS by the NPIS. It includes the product name, the name of the organisation notifying the product and the date that product was notified to the NPIS. It has no bearing on approval for marketing in the UK.

A. No. Submission of safety data to the NPIS is entirely voluntary and is free of charge. Receipt of SDS will be confirmed in all cases by email. A ‘certificate of notification’ is an optional service for those requiring additional confirmation of sds submission. This bespoke service incurs an administrative charge.

A. The United Kingdom withdrew from the European Union on January 31st 2020 though EU law continues to apply to and in the UK during the transition period until December 31st 2020. This includes the role of NPIS (Birmingham Unit) as the Appointed Body to receive chemical safety information from industry under Article 45 and Annex VIII of the EU Classification Labelling Packaging (CLP) Regulation. Until the end of the transition period the NPIS (Birmingham Unit) will continue to receive chemical safety data from industry directly on a voluntary basis. Discussions on the legal requirements for submission of these data to the UK post-Brexit remain ongoing. What will happen at the end of this period remains unclear and is currently being negotiated by the UK government. We will update the website to provide further information on this in due course.

A. The NPIS helpline number should not be listed under Section 1.4, unless it is explicitly stated that this number is for use only by healthcare professionals and an alternative number is provided for members of the public. The public helpline can either be a number your company provides or the NHS 111/NHS 24 public service numbers.

A. There is no obligation to generate / submit a UFI but the NPIS will register your product with its associated UFI if one has already been generated. Whether the UK will use UFIs beyond the transition period remains unclear.

A. If a company using the generator does not have an EU VAT number, they can check the box which states: "By ticking this box, I declare that the company does not have a VAT number or chose not to use it to generate a UFI." The use of the VAT number is a means to ensure that two different companies using the same formulation number will not produce the same UFI. If you require further clarification you may wish to email the European Chemicals Agency, ECHA using the following ECHA contact form

A. The NPIS acts as the Appointed Body to receive SDS on a voluntary basis only. We do not advise on other regulatory requirements. These queries should be addressed to the UK Health and Safety Executive.

A. Safety information are held on the NPIS Product Data Centre. The database is under constant development by the development team to ISO 9001 standards. Microsoft Azure data centre standards apply.