SPC submission
When submitting an application under the Regulation, the applicant includes a proposal for a draft SPC (in the language/languages required by the Member State. For the Ctgb the required languages are English and Dutch). Submission takes place with the aid of R4BP and IUCLID.
The Dutch SPC for a biocide product and the Dutch SPC for a biocide product family yopu can find below. In addition to the previous forms in WORD, an i6z document must also be supplied via R4BP. You create the SPC in i6z in IUCLID.
A Dutch SPC (in Word and i6z format) must be provided immediately upon submission of the application for the following application types:
- Simplified authorisations
- Mutual recognition
- Change of authorisation
- Authorisation of the same biocidal product
A Dutch SPC does not need to be provided immediately for a Union admission or parallel mutual recognition. The Dutch SPC can only be drawn up after the evaluating competent authority has established an English-language SPC in consultation with the countries involved.
In R4BP an SPC (summary of product characteristics) is requested in i6z. Depending on the type of application, we request an SPC in Dutch and/or English.
If the Ctgb assesses the application, they will make sure that the SPC is correct, readable and not ambiguous. If this is not the case, the SPC will be modified accordingly in consultation with the applicant. It is therefore crucial that the SPC is properly filled in by the applicant.
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Application type |
At application: |
After agreement on SPC |
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National application |
Family Word (EN) i6z (EN) |
Family Word (NL) i6z (NL) |
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Mutual recognition |
Family Word (EN) i6z (EN) |
Family Word (NL) i6z (NL) |
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Mutual recognition |
Family Word (NL) i6z (NL) |
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Same biocidal product |
Product Word (NL) i6z (NL) |
Family Word (NL) i6z (NL) |
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Minor change / |
For NL only: | |||
| Family Word (NL) i6z (NL) |
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| In case more countries are involved, additionally: |
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| Product Word (EN) i6z (EN) |
Family Word (EN) i6z (EN) |
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For biocidal product families, especially when they are large or complex, it is strongly advised to additionally provide an overview of the family using the following template.