Volete cercare la domanda e risposta pertinente nella vostra lingua? Basta cambiare la lingua nel menu a tendina in alto.
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
when the editor asks you to discard your current changes.
- Enter the target language and press <OK>.
Once you complete these steps, the free-text fields in the ‘Authorised uses’ and ‘Directions for use’ tabs will still contain the same text as the original SPC: you will need to manually complete the translation of these sections.
Final SPCs are read-only documents that cannot be edited. A lock 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 for changes, renewals – if you apply for changes on request or renewals;
- New >> Draft for simplified authorisations – if you modify a simplified authorisation; or
- New >> Draft from final SPC – for any other case that requires the modification of a final SPC.
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 SPC online editor may open a blank page depending on the cookies available in your web browser. You will need to remove the cookies following these instructions:
You may alternatively open your browser in private mode to bypass the blank page to be opened, using the following keyboard shortcuts (pressing the keys at the same time):
- In Internet Explorer and Firefox: Ctrl + Shift + P.
- In Chrome: Ctrl + Shift + N.