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

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 98 400 shall apply to each of the following requests:

(a) a request regarding quality, non-clinical and clinical development;

(b) a request regarding quality and clinical development;

(c) a request regarding non-clinical and clinical development;

(d) a request regarding qualification of novel methodologies. The remuneration for each of the two scientific advice coordinators shall be EUR 24 600 .

1.2. A fee of EUR 73 900 shall apply to each of the following requests:

(a) a request regarding clinical development;

(b) a request regarding quality and non-clinical development;

(c) a request regarding quality development and bioequivalence studies for generic medicinal products as defined in Article 10(2), point (b), of Directive 2001/83/EC. The remuneration for each of the two scientific advice coordinators shall be EUR 18 500 .

1.3. A fee of EUR 51 900 shall apply to each of the following requests:

(a) a request regarding quality development;

(b) a request regarding non-clinical development;

(c) a request regarding bioequivalence studies for generic medicinal products as defined in Article 10(2), point (b), of Directive 2001/83/EC. The remuneration for each of the two scientific advice coordinators shall be EUR 12 300 .

2. Authorisation to market a medicinal product falling within the scope of Regulation (EC) No 726/2004 2.1. A fee of EUR 865 200 shall apply to an application for a marketing authorisation for a medicinal product pursuant to Article 8(3) of Directive 2001/83/EC where the applicant claims a new active substance. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 272 200 for the rapporteur, EUR 237 100 for the co-rapporteur and EUR 25 500 for the Pharmacovigilance Risk Assessment Committee (PRAC) rapporteur.

2.2. A fee of EUR 690 700 shall apply to an application for a marketing authorisation for a medicinal product pursuant to Article 8(3) of Directive 2001/83/EC where the applicant claims a known active substance. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 191 600 for the rapporteur, EUR 179 500 for the co-rapporteur and EUR 18 600 for the PRAC rapporteur.

2.3. A fee of EUR 571 100 shall apply to an application for a fixed combination medicinal product pursuant to Article 10b of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 177 200 for the rapporteur, EUR 104 000 for the co-rapporteur and EUR 14 100 for the PRAC rapporteur.

2.4. A fee of EUR 732 400 shall apply to an application for a biological medicinal product which is similar to a reference biological product pursuant to Article 10(4) of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 296 200 for the rapporteur, EUR 190 000 for the co-rapporteur and EUR 24 300 for the PRAC rapporteur.

2.5. A fee of EUR 780 900 shall apply to an application for a marketing authorisation for a medicinal product pursuant to Article 10a of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 201 200 for the rapporteur, EUR 187 100 for the co-rapporteur and EUR 19 400 for the PRAC rapporteur.

2.6. A fee of EUR 177 900 shall apply to an application for a marketing authorisation for a generic medicinal product pursuant to Article 10(1) of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 78 300 for the rapporteur and EUR 3 900 for the PRAC rapporteur.

2.7. A fee of EUR 172 800 shall apply to an application based on informed consent for a marketing authorisation for a medicinal product pursuant to Article 10c of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 50 400 for the rapporteur and EUR 2 500 for the PRAC rapporteur.

2.8. A fee of EUR 426 100 shall apply to an application for a marketing authorisation for a medicinal product pursuant to Article 10(3) of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 111 600 for the rapporteur, EUR 111 600 for the co-rapporteur and EUR 11 200 for the PRAC rapporteur.

2.9. A fee of EUR 33 300 shall apply to the second and to each subsequent application for a marketing authorisation submitted pursuant to Article 10(1), (3) or (4) of Directive 2001/83/EC on patent grounds where indications or dosage forms of the reference medicinal product are still covered by patent law. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in the same application. The remuneration shall be EUR 8 500 for the rapporteur and EUR 1 300 for the co-rapporteur.

3. Scientific opinions and assessments prior to potential submission of an application for a marketing authorisation 3.1. The amounts of the fees and the amounts of the corresponding remuneration laid down in Section 2 shall apply to any of the following:

(a) an opinion on a medicinal product for compassionate use pursuant to Article 83 of Regulation (EC) No 726/2004;

(b) an assessment on an on-going basis of data packages of particulars and documents submitted to the Agency by a prospective applicant prior to a formal submission of an application for a marketing authorisation falling within the scope of Regulation (EC) No 726/2004.

3.2. The amounts applicable pursuant to points 3.1(a) and 3.1(b) shall cover all strengths, all pharmaceutical forms and all presentations submitted in the same application.

3.3. An additional fee and additional remuneration shall apply to the assessment set out in point 3.1(b). The amount of that additional fee and the amounts of the corresponding additional remuneration shall be equal to 15 per cent of the respective amounts for an application for a marketing authorisation for a medicinal product falling within the scope of Regulation (EC) No 726/2004 that are laid down in point 2.

3.4. In the event of multiple submissions of data packages submitted by the same prospective applicant for the same product, the fees applicable pursuant to point 3.1(b) and point 3.3 shall only be levied once, namely when the first data package is submitted.

3.5. The amounts applicable pursuant to points 3.1(a) and 3.1(b) shall be deducted from the respective fee and remuneration payable to competent authorities of the Member States for an application for a marketing authorisation for the same product, where such application is submitted by the same applicant.

4. Extension of a marketing authorisation within the meaning of Annex I to Regulation (EC) No 1234/2008 4.1. A fee of EUR 168 500 shall apply to an application for an extension of a marketing authorisation requiring only chemical, pharmaceutical or biological documentation and for which no clinical or non-clinical data are submitted. That fee shall cover a single pharmaceutical form and a single associated strength. The remuneration shall be EUR 56 700 for the rapporteur and EUR 33 300 for the co-rapporteur.

4.2. A fee of EUR 196 800 shall apply to an application for an extension of a marketing authorisation not covered by point 4.1. That fee shall cover a single pharmaceutical form and a single associated strength. The remuneration shall be EUR 69 300 for the rapporteur and EUR 39 100 for the co-rapporteur.

4.3. Without prejudice to points 4.1 and 4.2, a fee of EUR 33 300 shall apply to each application for an extension of a marketing authorisation on the basis of an application submitted under Article 10(1), (3) or (4) of Directive 2001/83/EC on patent grounds where indications or dosage forms of the reference medicinal product are still covered by patent law. The remuneration shall be EUR 8 500 for the rapporteur and EUR 1 300 for the co-rapporteur.

5. Major variation of type II to the terms of a marketing authorisation in accordance with Commission Regulation (EC) No 1234/2008 5.1. A fee of EUR 163 200 shall apply to an application for a major variation of type II as defined in Article 2, point 3, of Regulation (EC) No 1234/2008 for an addition of a new therapeutic indication or modification of an approved indication. The remuneration shall be EUR 57 300 for the rapporteur and EUR 57 300 for the co-rapporteur.

5.2. A fee of EUR 22 000 shall apply to an application for a major variation of type II not covered by point 5.1. The remuneration for the rapporteur shall be EUR 14 600 .

5.3. For each application for a major variation of type II that is grouped in a single application pursuant to Article 7 of Regulation (EC) No 1234/2008, the corresponding fee shall be levied as set out in points 5.1 and 5.2. Remuneration shall be paid in accordance with those points.

5.4. Where a work-sharing application pursuant to Article 20 of Regulation (EC) No 1234/2008 includes more than one centrally authorised product, the fees and remuneration specified in points 5.1 and 5.2 of this Annex shall apply to each variation of the first centrally authorised product, whereas a charge of EUR 900 shall apply to each variation of the second and subsequent centrally authorised product included in the application.

6. Referrals and scientific opinions pursuant to Article 5(3) of Regulation (EC) No 726/2004 6.1. A fee of EUR 163 900 shall apply to the assessment carried out in the context of a procedure initiated under Article 5(3) of Regulation (EC) No 726/2004. Such fee shall be waived in full. The remuneration shall be EUR 15 500 for the rapporteur and EUR 15 500 for the co-rapporteur.

6.2. A fee of EUR 313 500 shall apply to the assessment carried out in the context of a procedure initiated under Article 13 of Regulation (EC) No 1234/2008. Such fee shall be waived in full. The remuneration shall be EUR 19 200 for the rapporteur and EUR 19 200 for the co-rapporteur.

6.3. A fee of EUR 98 900 shall apply to the assessment carried out in the context of a procedure initiated under Article 29(4) of Directive 2001/83/EC. Such fee shall be waived in full. The remuneration shall be EUR 3 500 for the rapporteur and EUR 3 500 for the co-rapporteur.

6.4. A fee of EUR 153 100 shall apply to the assessment carried out in the context of a procedure initiated under Article 30 of Directive 2001/83/EC. The remuneration shall be EUR 8 500 for the rapporteur and EUR 8 500 for the co-rapporteur.

6.5. A fee of EUR 216 200 shall apply to the assessment carried out in the context of a procedure initiated under Article 31 of Directive 2001/83/EC where that procedure is initiated as a result of the evaluation of data other than data relating to pharmacovigilance. The remuneration shall be EUR 15 500 for the rapporteur and EUR 15 500 for the co-rapporteur.

6.6. A fee of EUR 206 600 shall apply to the assessment carried out in the context of a procedure initiated under Article 20 of Regulation (EC) No 726/2004 where that procedure is initiated as a result of the evaluation of data other than data relating to pharmacovigilance. The remuneration shall be EUR 21 900 for the rapporteur and EUR 21 900 for the co-rapporteur.

6.7. For an assessment carried out in the context of a procedure initiated as a result of the evaluation of pharmacovigilance data under Article 31(1), second subparagraph, Article 31(2) and Articles 107i, 107j and 107k of Directive 2001/83/EC or under Article 20(8) of Regulation (EC) No 726/2004, the following fees shall apply: 6.7.1. a fee of EUR 219 900 where one active substance or combination of active substances and one marketing authorisation holder are included in the assessment. The remuneration shall be EUR 28 600 for the rapporteur and EUR 28 600 for the co-rapporteur; 6.7.2. a fee of EUR 310 000 where two or more active substances or combinations of active substances and one marketing authorisation holder are included in the assessment. The remuneration shall be EUR 32 900 for the rapporteur and EUR 32 900 for the co-rapporteur; 6.7.3. a fee of EUR 377 100 where one or two active substances or combinations of active substances and two or more marketing authorisation holders are included in the assessment. The remuneration shall be EUR 40 100 for the rapporteur and EUR 40 100 for the co-rapporteur; 6.7.4. a fee of EUR 511 600 where more than two active substances or combinations of active substances and two or more marketing authorisation holders are included in the assessment. The remuneration shall be EUR 54 400 for the rapporteur and EUR 54 400 for the co-rapporteur.

6.8. Where two or more marketing authorisation holders are involved in the procedures referred to in points 6.4, 6.5, 6.6 and 6.7, 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 medicinal products for human use 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.

7. Evaluation of traditional herbal medicinal products in accordance with Article 57(1), point (n), of Regulation (EC) No 726/2004 A fee of EUR 34 900 shall apply to a request for scientific advice from the Committee on Herbal Medicinal Products related to traditional herbal medicinal products. The remuneration for the rapporteur shall be EUR 4 500 .

8. Certification of compliance with Union legislation for a plasma master file (PMF) in accordance with Part III of Annex I to Directive 2001/83/EC 8.1. A fee of EUR 69 000 shall apply to an application for review of a PMF and its initial certification pursuant to Part III, point 1.1, of Annex I to Directive 2001/83/EC. The remuneration shall be EUR 10 800 for the rapporteur and EUR 10 800 for the co-rapporteur.

8.2. A charge of EUR 6 900 shall apply to the issuing of an initial PMF certification where it is submitted simultaneously with an application for a marketing authorisation for a medicinal product under the centralised procedure. The PMF documentation shall be evaluated within the centralised marketing authorisation application.

8.3. A fee of EUR 12 800 shall apply to an application for review and certification of a major variation of type II to the PMF pursuant to Regulation (EC) No 1234/2008. The remuneration shall be EUR 2 000 for the rapporteur and EUR 2 000 for the co-rapporteur. For two or more major variations of type II grouped in a single application pursuant to Regulation (EC) No 1234/2008, the fee and remuneration laid down in point 8.4 of this Annex shall apply.

8.4. A fee of EUR 20 400 shall apply to an application for review and annual re-certification of a PMF which may include any variation pursuant to Regulation (EC) No 1234/2008 submitted simultaneously with the application for a PMF annual re-certification. The remuneration shall be EUR 2 400 for the rapporteur and EUR 2 400 for the co-rapporteur.

9. Certification of compliance with Union legislation for a vaccine antigen master file (VAMF) 9.1. A fee of EUR 69 000 shall apply to an application for review of a VAMF and its initial certification not submitted simultaneously with a new application for marketing authorisation under the centralised procedure pursuant to Part III, point 1.2, of Annex I to Directive 2001/83/EC. The remuneration shall be EUR 10 800 for the rapporteur and EUR 10 800 for the co-rapporteur.

9.2. In the case of a group of antigens aimed at preventing a single infectious disease, a fee shall be levied for the VAMF application for one antigen and remuneration shall be paid pursuant to point 9.1. The second and subsequent VAMF applications submitted simultaneously for antigens as part of the same group shall be charged a fee of EUR 9 500 for each VAMF. The total amount charged by the Agency for VAMF applications submitted simultaneously for antigens as part of the same group shall not exceed EUR 82 800 . In that case, the remuneration for each second and subsequent VAMF shall be EUR 2 400 for the rapporteur and EUR 2 400 for the co-rapporteur.

9.3. A charge of EUR 6 900 shall apply to an application for issuing each VAMF certification where it is submitted simultaneously with a new application for a marketing authorisation under the centralised procedure.

9.4. A fee of EUR 12 800 shall apply to an application for review and certification of a major variation of type II to the VAMF pursuant to Regulation (EC) No 1234/2008. The remuneration shall be EUR 1 900 for the rapporteur and EUR 1 900 for the co-rapporteur. For each major variation of type II that is grouped in a single application made pursuant to Regulation (EC) No 1234/2008 a fee shall be levied as set out in the first subparagraph of this point.