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The family SPC ensures that minimum information is provided in the different levels of a family SPCs. The meta SPC level is complete if minimum required data is provided in the products within a meta SPC and the meta SPC; the family SPC is complete if all the meta SPCs, administrative information and product information are considered as complete.
To provide the active substance name in the “Administrative information” section, first fill in the product information section.
Also, consider that the active substance concentration of a meta SPC cannot be specified until the concentration of the active substance is provided in the product information section. Likewise, the active substance concentration of the product cannot be provided until the active substance concentration range is specified within the related meta SPC the products belong to.
The SPC editor tool is supported by Internet Explorer 10, Firefox 29 and above or Google Chrome 35 and above. Compatibility issues may appear if you use Internet Explorer 11: just select the compatibility view icon to display the page correctly. If the compatibility view icon is not available, go to tools >> compatibility view settings and add "europa.eu" (or display all websites in compatibility view).
- For Internet Explorer:
- Click on the gear icon in the upper right corner, then click/tap on <View downloads>.
- Click on the <Browser> and define the location
- For Firefox and Google Chrome:
- From the Menu bar, select <Option>, then <General> and click on <Browse> to define the location.
If you submit an initial application where the SPC is required, go to the SPC editor, select “New” and provide all the minimum required information. Save the file and upload it in R4BP 3 when required by the wizard.
If you need to prepare an SPC when a case or asset is already in R4BP 3, you must edit the existing SPC in R4BP 3. This is the case when: you apply for a change on request; an authority asks you for further information, or the case has been migrated from R4BP2.
If the above applies, please follow these steps:
- Download the SPC from R4BP 3. Go to the case or asset, select the “SPC documents” sub-tab and click on “Download SPC”. Save it on your desktop.
- Go to the SPC editor, select “Open” and provide the minimum required information. Save the changes on your desktop.
- Upload your SPC XML file when required by the R4BP 3 wizard.
To technically pass the R4BP 3 upload step, you have to populate all mandatory fields. The SPC editor tool has a built-in feature that allows you to determine whether you have provided the minimum required information. If the error icon is displayed in the relevant tab () you are not providing the minimum information required.
In the example below, the error icon is displayed in the “H & P statements” tab because at least one hazard and precautionary statement must be provided (see the text in red in the example below).
When you enter <+Add hazard statement> and <+Add precautionary statement>, if applicable, the SPC will consider this minimum information as correctly entered.
To prepare an SPC that R4BP 3 will accept as a valid format, you need to use:
- a single numerical value or a single letter in the free-text fields; or
- a value from the respective dropdown lists.
Note: Ensure that the format of your file is correct following the instructions included in Q&A 1054.
You need to complete the following steps:
- Open the SPC file saved on your computer with the SPC online editor.
- Select New >> Draft from final SPC (only if you are working with a final SPC downloaded from R4BP 3).
- Click on New >> Market area version and press <OK> when the editor asks you to discard your current changes.
- Enter the target language and press <OK>.
Once you complete these steps, free-text fields in the Authorised uses and directions for use tabs will be emptied; however, you will still need to manually complete the translation of these sections.
Note: The section target organisms contains the description in English only.
'Final SPCs are read-only documents that cannot be edited. A locker icon under the language labelling section below the ECHA logo indicates that you are working with a final SPC. To edit a final SPC, you need to select New >> Draft from final SPC.
It is not yet possible to include more than one row in the SPC per precautionary statement. If an additional row is needed, insert this information in the "Other information" section.
When you import a family SPC, the following will occur when the file to be imported is opened:
- The current content will be kept. If you had an empty new template, both empty fields and the migrated content will be migrated: you may need to remove the empty meta SPCs/products.
- You need to select the meta SPCs to be imported one-by-one. Once you select the first meta, click on the space next to the first meta and select the second meta.
- Decide whether you need to preserve the meta SPC(s) and product identities. This may be applicable to you in cases where R4BP 3 demands consistency in your SPC based on available family/product UUIDs, i.e. same biocidal product applications.
Once you have added the first product type or type of formulation, click on the blank space next to the selected item to enter more options.
The main changes in the new version include:
- A new family SPC structure to accommodate the SPC to the new family SPC concept;
- A new way of handling families. It is no longer required to handle the family SPC and member SPCs in one application: only one file is required for family applications;
- Translations of free-text fields will remain available in the SPC to be translated.
- Classification and labelling is no longer available in the SPC.
- SPC version convertor (see Q&A 1054)
- Other functionalities (i.e. duplicate meta SPCs) apply for a same product from family member or pdf preview, and several fixes.
Further information on the SPC editor can be found in the BSM technical guide: using R4BP 3.