Introduction of new application forms
Regulatory Update 27/2009
Issued: 20 August 2009
Introduction
This Regulatory Update announces the introduction of 4 new application forms for applications for:
- Commercial & Experimental Approval of plant protection products (separate forms for Administrative and non-Administrative applications
- Specific Off-Label Approval of plant protection products
- Official Listing of Adjuvants.
Background
During 2008, we consulted with the UK Crop Protection Association (CPA) and other non-CPA companies about a new single application form for all commercial/experimental approvals. We suggested that applicants use the new form for their applications on a trial basis for a year. Our aim was to simplify form completion and to ensure that the information provided was the minimum needed for us to sift and evaluate applications.
Practical experience and company comments indicated that whilst the form was shorter and easier to complete, it lacked enough information for us to process the application efficiently. We therefore re-drafted two separate new forms (for Administrative and non-Administrative applications) and carried out a further limited-consultation with a small number of companies. The new drafts were well received and we have implemented the majority of additional comments received. These 2 new forms are now being released for use.
A similar exercise was originally carried out with the forms for Specific Off-Label Approval (SOLA) and Adjuvant Official Listing and which are now also being introduced.
New application forms
The following new forms are now available on-line and should be used with all new applications. If you are in the process of putting together applications using the existing forms then this is still acceptable. However, please use the new forms for any future applications.
If you have difficulty opening these forms then right click over the link and select "Save Target As..", save the document and then open from your local drive.
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1. |
Commercial or experimental approval of plant protection products where a technical assessment (data and/or reasoned cases) is required (No-Data, Data, Data-Plus or Major Change Streams) |
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2. |
Administrative Stream approval (not SOLAs or Adjuvants). |
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3. |
Specific Off-Label (SOLA)/ Extension Of Use. |
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4. |
Official Listing of Adjuvants. |
For other types of application, you should continue to use the existing forms as follows:
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1. |
Administrative Experimental Approval |
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2. |
Parallel Import |
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3. |
Biocidal product authorisation |
see HSE website |
Format of the forms
We have used a Microsoft Word format which should allow all applicants to complete them electronically. Please note that:
- You can only type in the unprotected areas (highlighted in grey). However, you have the option of adding additional tables or rows to tables necessary (e.g. where there are more data owners or technical specifications than can be listed in the available tables).
- To put a cross in the ‘check boxes’ you must double click on the box and then select ‘checked’/ press ‘OK’ in the dialogue box that appears.
- If you are unable to access or complete the forms or require forms that can be completed by hand please contact us at the address below.
Guidance
There is no separate guidance for completing the forms. The instructions in the forms themselves should be self-explanatory. Any queries on the information required (e.g. technical specification, formulation details, data access) can be found on our website. We suggest that you either use the ‘search’ function on the homepage or look at the information in the ‘Applicant Guide’ (the ‘guidance documents’ may be particularly useful). If this is not sufficient you can contact us at the address below,
‘Contact Details
Enquiries concerning this update should in the first instance be addressed to the applicant enquiry e-mail address:
Email: applicant-enquiries@hse.gsi.gov.uk
Postal address: Applicant Enquiry Team, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX, UK
Further information on what application forms are required and when can be found in The Applicant Guide.