Apply for UK Product Authorisation/Registration

The page explains the process for make an application for product authorisation/registration in the UK. A product is authorised if the active substance is on Annex I of the BPD and registered if the active substance is on Annex IA of the BPD.

The applicant should submit to HSE a completed application form together with the required dossier of information as outlined below.

Applications can either be sent electronically by email (preferred) or in hard copy by post. HSE will confirm receipt of the application. Unless otherwise indicated, all documentation should be in English.

Full and provisional product authorisation/registration

To apply for product authorisation/registration in the UK the following information is required:

• R4BP form;
• A dossier or letter(s) of access that satisfies the requirements of the following Annexes to the BPD
  • For the product, Annexes IIB and IIIB or Annexes IVA and IVB where the active/product is a micro-organism and
  • For each active substance in the product, Annexes IIA and III;
• A copy of the proposed label (and Safety Data Sheet) for the product as it will be placed on the market in the UK;
• Safety Data Sheet for all active and non actives substance;

To create R4BP applications see the guidance created by the EU Commission.

Mutual recognition

For applications for mutual recognition in the UK the following information will be required,

• A cover letter indicating that an application for product authorisation is being made in another Member State and mutual recognition of that product will be sought in the UK once that authorisation is granted (paper or e-mail)
• R4BP form.

Once the product has been authorised/registered by the reference Member State a formal application for Mutual Recognition must be made within 2 months to the UK. The application must contain the following information:

• A copy of the official authorisation granted by the Reference Member State or statement that this is available via R4BP. We require this as evidence that the authorisation has been granted. We will not require a version in English as all relevant information will be in the Product Assessment Report;
• A copy of the Product Assessment Report produced by the Reference Member State which should include a summery of the product characteristics;
• Summary dossier (Doc I-III on CD);
• A copy of the proposed label (and Safety Data Sheet) for the product as it will be placed on the market in the UK.

Additional information, over and above that presented to the Reference Member State may be required if there are any aspects to the product or its use specific to the UK, for instance differences in aspects such as climate or type of pests.

Where the application is based on a previously authorised product, for instance when based on a frame formulation or back-to-back, then the application should simply refer to the appropriate authorisation and provide a Letter of Access for that information if appropriate. However, please note that the product will still have to be entered into R4BP2.

To create R4BP applications see the guidance created by the EU Commission.

Frame Formulations

For application of products with in a frame formulation the following information is required,

• R4BP form to establish the frame and each product within the frame;
• A dossier or letter(s) of access that satisfies the requirements of the following Annexes to the BPD
  • For the product, Annexes IIB and IIIB or Annexes IVA and IVB where the active/product is a micro-organism; and.
  • For each active substance in the product, Annexes IIA and IIIA;
• Safety Data Sheet for all active and non actives substance within the frame.
  • A copy of the proposed label (and Safety Data Sheet) for each product as it will be placed on the market in the UK.

To create R4BP frame applications see the guidance created by the EU Commission

Data protection issues and Letter of Access

The applicant must have the legitimate use of the information provided in the application dossier. Where information is under data protection and the applicant does not own that information they must obtain a Letter of Access (LoA) from the information holder to allow them to use this information. This also applies where an applicant is referring to a back-to-back, me-too authorisation or frame formulation. The LoA should be submitted along with the application.

Register For Biocidal Products (R4BP)

The European Commission Register for Biocidal Products (R4BP) is a centralised system for managing much of the biocidal product authorisation work. R4BP provides a harmonised application form to be used for making applications for product authorisations in any Member State.

To access the R4BP applicants must first register under ECAS (the European Commission Authentification Service). This is the starting point for any data submission to the R4BP. This process will allow you to define the email address and the password that you will be requested to provide whenever you want to access the R4BP. This email address will also be used for every email that the R4BP will send to you. Once you have registered under ECAS, you can create your account in the R4BP.  Further information about creating your R4BP account and R4BP application forms can be found in the guidance created by the EU Commission.