AMOUNT 081: BIOCIDES RATES
REGULATION:
Act no. 22/2021 of 28 december, general budget of the state to 2022
.Final disposition 10th.Amendment to article 33 of law 53/2002 of 30 december, fiscal, administrative and Social. Five: level of rates.
| KEY TO RATE | CONCEPT | €AMOUNT |
|---|---|---|
| 1 | By assessing a dossier of an active substance (new or existing) for inclusion in annex I, IA and IB | 120.751,68 |
| 2 | For evaluation (authorization or registration) of a file of a product biocide | 24.150,34 |
| 3 | For evaluation (authorization or registration) of a dossier in implementation of framework formulation | 3.018,80 |
| 4 | In recognition of authorisations or records granted to other member states | 3.018,80 |
| 5 | By granting provisional approvals (product + active substance) | 12.075,17/Product + 9.660,13/active substance |
| 6 | For temporary use of biocidal products (120 days) | 24.150,34 |
| 7 | In a notification on the procedure aimed at research and development | 2.535,80 |
| 8 | For renewing biocidal products referred to in points 2 and 3 | 18.112,75/2.264,10 |
| 9 | By significant changes to the biocidal products referred to in points 2 and 3 (Ex: changes in the formulation, extensions of use) | 9.660,14/1.207,35 |
| 10-) | For minor modifications in the biocidal products which is covered in points 2 and 3: Technical modifications (Ex: changes in the classification and labelling) | 1.449,02// 181,13 |
| 10 (b) | For minor modifications in the biocidal products which is covered in points 2 and 3: Administrative changes (Ex: climate change name product holder) | 240,5/30,18 |
| 11) | For the authorisation of pesticide use of environmental and food industry containing active substances in place before the review on the basis of the directive 98/8/EC: Active substances | 724,49 |
| 11 (b) | For the authorisation of pesticide use of environmental and food industry containing active substances in place before the review on the basis of the directive 98/8/EC: Formulations | 724.49 |
| 12 | For renewal of authorisation of products that are referred to in paragraph 11 | 543,38 |
| 13 | By extension of authorization of a product has already been referred to in paragraph 11 | 362,25 |
| 14 | By significant changes to the products referred to in paragraph 11 (Ex: changes in the formulation, extensions of use) | 543,38 |
| 15 (a) | For minor modifications in the products referred to in point 11: Technical modifications (Ex: changes in classification and labelling) | 181,13 |
| 15 (b) | For minor modifications in the products referred to in point 11: Administrative changes (Ex: changes name product, climate, climate manufacturer) | 181,13 |
Eight. When the applicant of the authorization is a small or medium-sized enterprises (SMES), apply a REDUCED AMOUNT in accordance with the following criteria:
a) fee reductions applicable to the applications for approval, or renewal of endorsement and inclusion in annex I of active substances of regulation (EU) no. 528/2012 when the manufacturer of active substance is an sme established in the european union except if the active, substance is a candidate for the replacement:
- Micro-enterprises: 60 per cent.
- Small businesses: 40 per cent.
- Medium-sized enterprises: 20 per cent.
(b) reductions in the rates applicable to requests for authorization or renewal of biocides or families of biocidal products, if the future incumbent of the authorization is an sme established in the european union except if the product contained any active substance to the replacement candidate:
- Micro-enterprises: 30 per cent.
- Small businesses: 20 per cent.
- Medium-sized enterprises: 10 per cent.
These reductionsNOthey shall be applied when the application belongs to the authorization or renewal of authorisation of a candidate for active substance replacement or when applications for authorization of biocidal products containing active substances candidates to the replacement. The applicant to prove the status of smes.
With respect to subparagraph (b), the possible fee reductions are applicable to the requests in accordance with the following keys of fees: 2, 3, 4, 5 and 8 as it relates to authorisation procedures or, if any, of renewal, which are covered in the regulation, 528/2012 on marketing and use of biocides. For a corresponding reduction shall submit, by this platform a statement on their status responsible smes according to the definition contained in annex I to the regulation (EU) no. 651/2014 of the commission on 17 june 2014(
Model statement for the accreditation of the status of smes).
To determine if your company or not it is an sme can access the website of the ministry of industry, commerce and tourism, where you can find information on the matter, as well as a tool for self-assessment of the status of smes in accordance with the definition of annex I to the above-mentioned regulations:
Furthermore, we inform you that the competent authority reserves the right to carry out verification activities may require companies to show documentary evidence that the condition of smes, in his case.
In the case that the company was unable to prove that status, will have to pay a supplement to the correct rate without constraining other sanctions that could be implemented.
EXPLANATORY NOTES
- Fee for same product application (according to the R4BP3 platform codes: BBS or BBP): as a result that in the different amounts that are established, these types of applications are not included, we inform you that the same biocidal product application will be adjusted to the fee key 3. If the family has more than 1 meta-SPC, the amount of the fee 3 will be multiplied by the number of meta-SPC of the family.
- Fee for a biocidal product family application (applied for as APP): as a result that in the different amounts that are established, this type of application (as a family) is not included, we inform you that this procedure will be adjusted to a fee key 2 including 1 meta-SPC. In the case of an application for a family with more than 1 meta-SPC, the amount of fee key 3 will be multiplied by the remaining number of meta-SPC of the family and will add up to the fee key 2.
- Fee for a biocidal product family application (applied for as MRP/MRS): as a result that in the different amounts that are established, this type of application (as a family) is not included, we inform you that this procedure will be adjusted to a fee key 4 including 1 meta-SPC. In the case of an application for a family with more than 1 meta-SPC, the amount of fee key 4 will be multiplied by the number of meta-SPC of the family.
- Fee for a biocidal product family application (applied for as RNL of a authorised product by APP): as a result that in the different amounts that are established, this type of application (as a renewal of a family) is not included, we inform you that this procedure will be adjusted to a fee key 8 (18112.75€) including 1 meta-SPC. In the case of an application for a family with more than 1 meta-SPC, to this amount (18112.75€) would be added the amount of 2264.10€ multiplied by the number of remaining meta-SPCs.
- Fee for a biocidal product family application (applied for as RNL of a authorised product by MR or BB): as a result that in the different amounts that are established, this type of application (as a renewal of a family) is not included, we inform you that this procedure will be adjusted to a fee key 8 (2264.10€) including 1 meta-SPC. In the case of an application for a family with more than 1 meta-SPC, the amount of fee key 8 will be multiplied by the number of meta-SPC of the family
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