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Fees, charges and remuneration for assessment procedures and services relating to veterinary medicinal products

1. Scientific advice provided by the Agency in accordance with Article 57(1), point (n), of Regulation (EC) No 726/2004 1.1. A fee of EUR 35 100 shall apply to each of the following requests:

(a) a request regarding quality, safety and clinical development;

(b) a request regarding quality and clinical development;

(c) a request regarding safety and clinical development; The remuneration for the scientific advice coordinator shall be EUR 16 700 .

1.2. A fee of EUR 25 700 shall apply to each of the following requests:

(a) a request regarding clinical development;

(b) a request regarding quality and safety development;

(c) a request regarding quality development and bioequivalence studies for generic veterinary medicinal products as defined in Article 4, point (9), of Regulation (EU) 2019/6. The remuneration for the scientific advice coordinator shall be EUR 10 700 .

1.3. A fee of EUR 22 600 shall apply to each of the following requests:

(a) a request regarding quality development;

(b) a request regarding safety development;

(c) a request regarding bioequivalence studies for generic veterinary medicinal products as defined in Article 4, point (9), of Regulation (EU) 2019/6;

(d) a request for a preliminary risk profile;

(e) a request related to the setting of a new maximum residue limit (MRL). The remuneration for the scientific advice coordinator shall be EUR 6 500 .

2. Request for classification of a veterinary medicinal product as intended for a limited market as defined in Article 4, point (29), of Regulation (EU) 2019/6 and for consideration for eligibility for authorisation in accordance with Article 23 of that Regulation A charge of EUR 5 500 shall apply to a request for classification of a veterinary medicinal product as intended for a limited market as defined in Article 4, point (29), of Regulation (EU) 2019/6 and for consideration for eligibility for authorisation pursuant to Article 23 of Regulation (EU) 2019/6.

3. Establishment, modification or extension of an MRL in accordance with the procedure laid down in Regulation (EC) No 470/2009 3.1. A fee of EUR 89 700 shall apply to an application to set an initial MRL for a given substance. The remuneration shall be EUR 22 700 for the rapporteur and EUR 10 900 for the co-rapporteur.

3.2. A fee of EUR 56 100 shall apply to each application to modify or to extend an existing MRL. The remuneration shall be EUR 11 200 for the rapporteur and EUR 10 300 for the co-rapporteur.

3.3. A fee of EUR 25 700 shall apply to the assessment to determine whether a chemical-unlike biological substance requires a full MRL evaluation or not pursuant to Section I.7 of Annex I to Regulation (EU) 2018/782. The remuneration for the rapporteur shall be EUR 10 700 .

4. Authorisation to market veterinary medicinal products falling within the scope of the centralised marketing authorisation procedure pursuant to Article 42 of Regulation (EU) 2019/6 4.1. A fee of EUR 313 000 shall apply to an application for a marketing authorisation for a veterinary medicinal product pursuant to Article 8, 23 or 25 of Regulation (EU) 2019/6 where the applicant claims a new active substance. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application, irrespective of the number of target species. The remuneration shall be EUR 113 300 for the rapporteur and EUR 40 400 for the co-rapporteur.

4.2. A fee of EUR 283 600 shall apply to an application for a marketing authorisation for a veterinary medicinal product pursuant to Article 8, 20, 22, 23 or 25 of Regulation (EU) 2019/6 where the applicant claims a known active substance. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application, irrespective of the number of target species. The remuneration shall be EUR 87 000 for the rapporteur and EUR 37 400 for the co-rapporteur.

4.3. A fee of EUR 144 900 shall apply to any of the following applications:

(a) an application for a marketing authorisation for a generic veterinary medicinal product pursuant to Article 18 of Regulation (EU) 2019/6;

(b) an application for a marketing authorisation for a hybrid veterinary medicinal product pursuant to Article 19 of Regulation (EU) 2019/6;

(c) an application based on informed consent for a marketing authorisation for a veterinary medicinal product pursuant to Article 21 of Regulation (EU) 2019/6. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in the same application, irrespective of the number of target species. The remuneration shall be EUR 32 600 for the rapporteur and EUR 19 000 for the co-rapporteur.

5. Re-examination of a marketing authorisation for limited markets A fee of EUR 20 100 shall apply to an application for a re-examination of a marketing authorisation for a limited market pursuant to Article 24(3) of Regulation (EU) 2019/6. The remuneration shall be EUR 3 300 for the rapporteur and EUR 2 500 for the co-rapporteur.

6. Variations to the terms of a marketing authorisation, requiring assessment in accordance with Articles 64, 65 and 66 of Regulation (EU) 2019/6 6.1. A fee of EUR 93 000 shall apply to a variation requiring assessment introducing changes of active substance(s), strength, pharmaceutical form, route of administration or food-producing target species, which are to be assessed within 90 days in accordance with Article 66(3) of Regulation (EU) 2019/6. That fee shall be levied for each single pharmaceutical form or each single associated strength or potency. The remuneration shall be EUR 30 300 for the rapporteur and EUR 9 100 for the co-rapporteur.

6.2. A fee of EUR 50 300 shall apply to variations requiring assessment that introduce changes to safety, efficacy or pharmacovigilance, which are to be assessed within 60 or 90 days, as the case may be, in accordance with Article 66(3) of Regulation (EU) 2019/6. The remuneration shall be EUR 10 400 for the rapporteur and EUR 8 100 for the co-rapporteur.

6.3. A fee of EUR 25 300 shall apply to variations requiring assessment introducing quality changes only, which are to be assessed within 60 days in accordance with Article 66(3) of Regulation (EU) 2019/6. The remuneration shall be EUR 3 800 for the rapporteur and EUR 3 800 for the co-rapporteur.

6.4. Where several variations requiring assessment are grouped in a single application under Article 64 of Regulation (EU) 2019/6, the corresponding fee as set out in points 6.1, 6.2 and 6.3 of this Annex shall apply to each of the first two variations. Remuneration shall be paid in accordance with those points. For the third and subsequent variations, the fee shall be EUR 12 700 per variation and the remuneration shall be EUR 1 900 per variation for the rapporteur and EUR 1 900 for the co-rapporteur.

6.5. Where a work-sharing application pursuant to Article 65 of Regulation (EU) 2019/6 includes more than one centrally authorised product, the fees and remuneration specified in points 6.1, 6.2 and 6.3 of this Annex shall apply to each variation of the first centrally authorised product, whereas a charge of EUR 800 shall apply to each variation of the second and subsequent centrally authorised product included in that application.

7. Referrals and arbitration procedures 7.1. A fee of EUR 161 800 shall apply to the assessment carried out in the context of a procedure initiated under Article 54(8) of Regulation (EU) 2019/6. Such fee shall be waived in full. The remuneration shall be EUR 22 400 for the rapporteur and EUR 10 200 for the co-rapporteur.

7.2. A fee of EUR 221 700 shall apply to the assessment carried out in the context of a procedure initiated under Article 70(11) of Regulation (EU) 2019/6. Such fee shall be waived in full. The remuneration shall be EUR 30 900 for the rapporteur and EUR 13 700 for the co-rapporteur.

7.3. A fee of EUR 155 900 shall apply to the assessment carried out pursuant to Article 141(1), points (c) and (e), of Regulation (EU) 2019/6. Such fee shall be waived in full. The remuneration shall be EUR 18 500 for the rapporteur and EUR 8 200 for the co-rapporteur.

7.4. A fee of EUR 221 700 shall apply to the assessment carried out in the context of a procedure initiated under Article 82 of Regulation (EU) 2019/6. The remuneration shall be EUR 30 900 for the rapporteur and EUR 13 700 for the co-rapporteur.

7.5. A fee of EUR 155 900 shall apply to the assessment carried out in the context of a procedure initiated under Article 129(3) or Article 130(4) of Regulation (EU) 2019/6. The remuneration shall be EUR 18 500 for the rapporteur and EUR 8 200 for the co-rapporteur.

7.6. Where two or more marketing authorisation holders are involved in the procedures referred to in point 7.4 or 7.5, the amount payable by each marketing authorisation holder shall be calculated by the Agency in two steps, as follows:

(a) first, by dividing the total amount of the fee among the marketing authorisation holders proportionally to the number of chargeable units in relation to veterinary medicinal products corresponding to products included in the procedure which are held by each of those marketing authorisation holders; and (b) second, by subsequently applying the fee reduction laid down in Section 1 of Annex V, where relevant.

8. Certification of compliance with Union legislation for vaccine antigen master files (VAMF) 8.1. A fee of EUR 25 300 shall apply to an application for review of a VAMF and its certification pursuant to point V.2 of Annex II to Regulation (EU) 2019/6 when it is submitted simultaneously with an initial application for a marketing authorisation for a veterinary medicinal product under the centralised procedure containing the named antigen. The remuneration shall be EUR 3 800 for the rapporteur and EUR 3 800 for the co-rapporteur.

8.2. For multiple VAMF applications submitted simultaneously in the context of the same initial marketing authorisation application, a fee of EUR 25 300 shall apply to each VAMF. The total amount levied by the Agency shall not exceed EUR 76 000 . The remuneration shall be EUR 3 800 for the rapporteur and EUR 3 800 for the co-rapporteur for each VAMF. The remuneration shall not exceed EUR 11 400 for the rapporteur and EUR 11 400 for the co-rapporteur.

8.3. A fee of EUR 35 100 shall apply to an application for the review of a VAMF and its certification when submitted as a separate application for an antigen in vaccine(s) already authorised under the centralised, decentralised or mutual recognition procedure. The remuneration shall be EUR 5 300 for the rapporteur and EUR 5 300 for the co-rapporteur.

8.4. Section 6 of this Annex shall apply to variations to a certified VAMF.

9. Certification of compliance with Union legislation for vaccine platform technology master files (vPTMF) 9.1. A fee of EUR 25 300 shall apply to an application for the review of a vPTMF and its certification pursuant to point V.4 of Annex II to Regulation (EU) 2019/6 when submitted simultaneously with an initial application for a marketing authorisation for a veterinary medicinal product under the centralised procedure containing the named platform. The remuneration shall be EUR 3 800 for the rapporteur and EUR 3 800 for the co-rapporteur.

9.2. A fee of EUR 35 100 shall apply to an application for the review of a vPTMF and its certification when submitted as a separate application for a platform in vaccines already authorised under the centralised, decentralised or mutual recognition procedure. The remuneration shall be EUR 5 300 for the rapporteur and EUR 5 300 for the co-rapporteur.

9.3. Section 6 of this Annex shall apply to variations to a certified vPTMF.