Fees vary from BGN 1,500 to BGN 40,180
The old one tafira of feescollected by the Food Chain Risk Assessment Center (CORHV), completely disappears, as it comes in its place new tariffpublished today, August 20, 2024, in the State Gazette. It was adopted by Government Decree No. 300 and will enter into force on January 1, 2025.
For started proceedings, for which fees have been paid on the basis of the canceled tariff, no additional payment/reimbursement of the difference in the amount of fees is due, the additional regulations say.
In the regulations, we read that only for the admissibility of the application for each area of active substance, antidote and synergist, 1500 BGN is paid (Article 2). For an assessment with an assessment report, for each assessment option the fee jumps to BGN 40,180.00. When an assessment of corroborating information is carried out, it will cost BGN 13,800.00.
The approval and renewal of the approval of the active substance, antidote and synergist costs BGN 40,180.00.
To carry out an assessment with an assessment report for authorization and amendment of an authorization for the placing on the market and the use of a plant protection product (PPR), when Bulgaria is the member state examining the application – for each area of assessment the fee is BGN 21,000.00 .;
If Bulgaria is an interested member state – for each area of evaluation BGN 1,700.00, etc.
See fees below:
RESOLUTION No. 300 OF AUGUST 16, 2024.
to approve the Tariff for the fees collected by the Food Chain Risk Assessment Center
THE MINISTERIAL COUNCIL
RESOLUTIONS:
Member only. Approves the Tariff for the fees collected by the Food Chain Risk Assessment Centre.
Final provisions
§ 1. The Tariff for the fees collected by the Food Chain Risk Assessment Center, approved by Resolution No. 223 of the Council of Ministers of 2016 (Government Gazette, No. 69 of 2016), is repealed.
§ 2. The decree enters into force on January 1, 2025.
TARIFF
for the fees collected by the Food Chain Risk Assessment Centre
Section I
Food chain risk assessment fees
Art. 1. (1) To carry out a scientific evaluation under Art. 4, para. 1 of the Law on the Food Chain Risk Assessment Center, a fee of BGN 2,800.00 is payable.
(2) To carry out a scientific evaluation under para. 1 within 3 working days, a double fee is payable.
Section II
Fees for carrying out activities for the approval, renewal and review of the approval of active substances, antidotes and synergists
Art. 2. (1) To carry out activities for approval of active substance, antidote and synergist according to Art. 7 – 11 of Regulation (EC) No. 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing on the market of plant protection products and repealing Directives 79/117/EEC and 91/414/EEC of Council (OJ, L 309/1 of November 24, 2009), hereinafter referred to as “Regulation (EC) No. 1107/2009”, when the Republic of Bulgaria is the rapporteur, a fee shall be paid as follows:
1. for the admissibility of the application, for each area of assessment – BGN 1,500.00;
2. for carrying out an assessment with an assessment report, for each area of assessment – BGN 40,180.00;
3. to carry out an assessment of corroborating information referred to in art. 6, letter “f” of Regulation (EC) No. 1107/2009 – BGN 13,800.00.
(2) To carry out activities to renew the approval of an active substance, antidote and synergist according to Art. 14 – 21 of Regulation (EC) No. 1107/2009, when the Republic of Bulgaria is the rapporteur, a fee shall be paid as follows:
1. for the admissibility of the application – for each area of evaluation BGN 1,500.00;
2. for carrying out an assessment with an assessment report – for each area of assessment BGN 40,180.00;
3. to carry out an assessment of corroborating information referred to in art. 6, letter “f” of Regulation (EC) No. 1107/2009 – BGN 13,800.00.
(3) To carry out the activities of approval and renewal of the approval of an active substance, antidote and synergist under para. 1 and 2, when the Republic of Bulgaria is a co-depositor, a fee shall be paid as follows:
1. for carrying out an assessment with an assessment report – for each area of assessment BGN 40,180.00;
2. for reviewing an evaluation report prepared by the rapporteur member state and submitting comments on the report – for each evaluation area BGN 17,600.00.
Art. 3. To carry out an assessment of identity or equivalence of a source of production of active substance, antidote and synergist according to Art. 38 of Regulation (EC) No. 1107/2009 or when the production process is changed, a fee of BGN 11,000.00 is payable for each source.
Art. 4. A fee of BGN 17,000.00 is payable for an assessment with an assessment report in the event of a change in the maximum permissible limit of a residual substance (approved active substance).
Section III
Fees for evaluation of plant protection products
Art. 5. (1) To carry out an assessment with an assessment report for authorization and amendment of an authorization for the placing on the market and the use of a plant protection product (PP) pursuant to Art. 33 – 39 of Regulation (EC) No. 1107/2009, a fee is payable as follows:
1. when the Republic of Bulgaria is the member state examining the application – for each area of assessment BGN 21,000.00;
2. when the Republic of Bulgaria is an interested member state – BGN 1,700.00 for each area of assessment.
(2) When the PRZ under para. 1 is declared as identical to the authorized PRZ in terms of specification and content of active substances, antidotes and synergists, type of formulation and content of the same or equivalent co-formulants, the fee is BGN 2460.00.
(3) When performing the assessment with an assessment report under para. 1 and 2, a comparative assessment is made under Art. 50 of Regulation (EC) No. 1107/2009, to the fee under para. 1, items 1 and 2 and para. 2 a fee of BGN 4,200.00 is payable.
Art. 6. (1) To carry out an assessment with an assessment report for authorizing the marketing and use of a medicinal product authorized in another member state through mutual recognition of authorizations pursuant to Art. 40, paragraph 1, letters “a” and “c”, Art. 41 and 42 of Regulation (EC) No. 1107/2009, a fee of BGN 1,700.00 is payable for each assessment area.
(2) To carry out an assessment with an assessment report for authorizing the marketing and use of a medicinal product authorized in another member state through mutual recognition of authorizations pursuant to Art. 40, paragraph 1, letter “b”, Art. 41 and 42 of Regulation (EC) No. 1107/2009, a fee of BGN 3,400.00 is payable for each assessment area.
(3) When performing the assessment with an assessment report under para. 1, a comparative assessment is made under Art. 50 of Regulation (EC) No. 1107/2009, to the fee under para. 1 a fee of BGN 4,200.00 is payable.
Art. 7. To carry out an assessment with an assessment report for authorizing the placing on the market and the use of low-risk PPE according to Art. 47 of Regulation (EC) No. 1107/2009, a fee of BGN 13,300.00 is payable.
Art. 8. To carry out an assessment with an assessment report for authorizing the placing on the market and the use of PRP for parallel trade according to Art. 52 of Regulation (EC) No. 1107/2009, a fee of BGN 2500.00 is payable.
Art. 9. (1) To carry out an evaluation with an evaluation report for the renewal of authorization for placing on the market and use of the PRZ according to Art. 43 of Regulation (EC) No. 1107/2009, a fee is payable as follows:
1. when the Republic of Bulgaria is the member state examining the application – for each area of assessment BGN 12,000.00;
2. when the Republic of Bulgaria is an interested member state – BGN 1,700.00 for each area of assessment.
(2) When performing the assessment with an assessment report under para. 1, a comparative assessment is made under Art. 50 of Regulation (EC) No. 1107/2009, to the fee under para. 1, items 1 and 2, a fee of BGN 4,200.00 is payable.
Art. 10. To carry out an evaluation with an evaluation report for the amendment of a permit for placing on the market and use of a medicinal product pursuant to Art. 45 of Regulation (EC) No. 1107/2009, a fee of BGN 1,700.00 is payable.
Additional provision
§ 1. For the purposes of the tariff, “Valuation Area” is any valuation range specified in Art. 9, para. 1, items 1 – 6 of the Law on the Center for Risk Assessment in the Food Chain.
Transitional and final provisions
§ 2. The tariff is accepted on the basis of Art. 6, para. 4 of the Law on the Food Chain Risk Assessment Center.
§ 3. No additional payment/reimbursement of the difference in the amount of the fees is due for initiated proceedings for which fees have been paid on the basis of the canceled tariff.
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