ANNEX IU.K.
Fees relating to active substances
| Table 1 | ||
| Standard fees | ||
| General description of task; relevant provision in Regulation (EU) No 528/2012 | Specific condition or task description | Fee (EUR) |
|---|---|---|
| Approval of an active substance; Article 7(2) | Fee for the first product-type for which that active substance is approved | 120 000 |
| Additional fee per additional product-type | 40 000 | |
| Additional fee per product-type (for both the first product-type and any additional product-type) if the active substance is a candidate for substitution in accordance with Article 10 of Regulation (EU) No 528/2012 | 20 000 | |
| Fee for the amendment of an approval, other than the addition of a product-type. | 20 000 | |
| Renewal of an approval; Article 13(3) | Fee for the first product-type for which renewal of that active substance is sought | 15 000 |
| Additional fee per additional product-type | 1 500 | |
| Additional fee for the first product-type for which renewal of that active substance is sought in case a full evaluation is found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012 | 25 000 | |
| Additional fee per additional product-type in case a full evaluation is found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012 | 2 500 | |
| Additional fee per product-type (for both the first product-type and any additional product-type) if the active substance is a candidate for substitution in accordance with Article 10 of Regulation (EU) No 528/2012 | 20 000 | |
| Inclusion in Annex I of an active substance; Article 28 | Fee for the first inclusion in Annex I of an active substance | 10 000 |
| Fee for the amendment of an inclusion of an active substance in Annex I | 2 000 | |
| Notification in accordance with Article 3a of Regulation (EC) No 1451/2007 | Fee per substance/product-type combination. The fee for the notification shall be deducted from the subsequent application in accordance with Article 7 of Regulation (EU) No 528/2012. | 10 000 |
| Table 2 | |
| Fee reductions for applications for the approval, renewal of approval, inclusion in Annex I of active substances if the active substance manufacturer is an SME established in the Union, except where the active substance is a candidate for substitution | |
| Type of enterprise | Reduction (% of the standard fee) |
|---|---|
| Micro enterprise | 60 |
| Small enterprise | 40 |
| Medium enterprise | 20 |
ANNEX IIU.K.
Fees for Union authorisation of biocidal products
| Table 1 | ||
| Standard fees | ||
| General description of task; relevant provision in Regulation (EU) No 528/2012 | Specific condition or task description | Fee (EUR) |
|---|---|---|
| Granting of Union authorisation, single product; Article 43(2) | Fee per product not identical with (one of) the representative product(s) assessed for the purpose of the substance approval | 80 000 |
| Fee per product identical with (one of) the representative product(s) assessed for the purpose of the substance approval | 40 000 | |
| Additional fee per product when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required | 40 000 | |
| Additional fee per product when the requested authorisation is provisional in accordance with Article 55(2) of Regulation (EU) No 528/2012 | 10 000 | |
| Granting of Union authorisation, biocidal product family; Article 43(2) | Fee per family | 150 000 |
| Additional fee per family when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required | 60 000 | |
| Additional fee per family when the requested authorisation is provisional in accordance with Article 55(2) of Regulation (EU) No 528/2012 | 15 000 | |
| Notification to the Agency of an additional product within a biocidal product family; Article 17(6) | Fee per additional product | 2 000 |
| Union authorisation of a same biocidal product; Article 17(7) | Fee per product constituting a ‘same product’ within the meaning of Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Councila | 2 000 |
| Major change of an authorised product or product family; Article 50(2) | Fee per application | 40 000 |
| Minor change of an authorised product or product family; Article 50(2) | Fee per application | 15 000 |
| Administrative change of an authorised product or product family; Article 50(2) | Fee per notification | 2 000 |
| Recommendation on the classification of a change of an authorised product or product family; Article 50(2) | Fee per request in accordance with Regulation (EU) No 354/2013. If the recommendation is to classify the change as an administrative or minor change, the fee for the request shall be deducted from the subsequent application or notification in accordance with Regulation (EU) No 354/2013. | 2 000 |
| Renewal of Union authorisation, single product; Article 45(3) | Fee per product | 5 000 |
| Additional fee per product in case a full evaluation is found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012 | 15 000 | |
| Additional fee per product when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required | 40 000 | |
| Renewal of Union authorisation, biocidal product family; Article 45(3) | Fee per product family | 7 500 |
| Additional fee per product family in case a full evaluation is found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012 | 22 500 | |
| Additional fee per product family when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required | 60 000 | |
| Table 2 | |
| Fee reductions for applications for the granting and renewal of Union authorisation of biocidal products or biocidal product families, if the prospective authorisation holder is an SME established in the Union, except where the product contains an active substance which is a candidate for substitution | |
| Type of enterprise | Reduction (% of the standard fee) |
|---|---|
| Micro enterprise | 30 |
| Small enterprise | 20 |
| Medium enterprise | 10 |
ANNEX IIIU.K.
Other fees
| General description of task; relevant provision in Regulation (EU) No 528/2012) | Specific condition or task description | Fee (EUR) |
|---|---|---|
| Technical equivalence; Article 54(3) | Fee, when difference between the active substance sources is limited to a change in manufacturing location, and application is based solely on analytical data | 5 000 |
| Fee, when difference between the active substance sources goes beyond a change in the manufacturing location, and application is based solely on analytical data | 20 000 | |
| Fee when previous conditions are not met. | 40 000 | |
| Annual fee for biocidal products authorised by the Union; Article 80(1)(a) | Fee per Union authorisation of a biocidal product | 10 000 |
| Fee per Union authorisation of a biocidal product family | 20 000 | |
| Mutual Recognition Submission fee; Article 80(1)(a) | Fee per product or product family concerned by an application for mutual recognition, per Member State where mutual recognition is sought | 700 |
| Appeal; Article 77(1) | Fee per appeal | 2 500 |
| Submission for inclusion in the list of relevant persons; Article 95 | Fee per submission of a letter of access to a dossier already found complete by the Agency or an evaluating Competent Authority | 2 000 |
| Fee per submission of a letter of access to part of a dossier already found complete by the Agency or an evaluating Competent Authority, together with complementary data | 20 000 | |
| Fee per submission of a new dossier | 40 000 | |
| Requests under Article 66(4) submitted to the Agency | Fee per item for which confidentiality is requested | 1 000 |