Annexes to COM(2013)472 - Fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use

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dossier COM(2013)472 - Fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal ...
document COM(2013)472 EN
date May 15, 2014
ANNEX

PART I

FEE FOR ASSESSMENT OF PERIODIC SAFETY UPDATE REPORTS REFERRED TO IN ARTICLE 4

1.The fee for the assessment of periodic safety update reports shall be EUR 19 500 per procedure. From that amount, the remuneration for the rapporteur shall be EUR 13 100. That remuneration shall be shared, where applicable, between the rapporteur and the co-rapporteur(s).

2.For the purpose of calculating the amount to be levied on each marketing authorisation holder in application of Article 4(4), the Agency shall calculate the proportion of chargeable units held by each marketing authorisation holder concerned of the total number of chargeable units held by all marketing authorisation holders involved in the procedure.

The share payable by each marketing authorisation holder shall be calculated by:

(a)dividing the total amount of the fee among the marketing authorisation holders concerned proportionately to the number of chargeable units; and

(b)subsequently applying the fee reduction as set out in point 3 of this Part and the fee exemption referred to in Article 1(4), where relevant.

3.In application of Article 4(5), small and medium-sized enterprises shall pay 60 % of the applicable amount.

4.Where the fee reduction or the fee exemption applies, the remuneration for the rapporteur and, where applicable, co-rapporteur(s) shall also be adapted proportionally. Where the Agency subsequently collects the full applicable amount, including the 10 % increase as provided for in Article 8(5), the remuneration for the rapporteur and, where applicable, co-rapporteur(s) shall also be adapted proportionally.

PART II

FEE FOR ASSESSMENT OF A POST-AUTHORISATION SAFETY STUDIES REFERRED TO IN ARTICLE 5

1.The fee for the assessment of each post-authorisation safety study shall be EUR 43 000 to be paid in two instalments as follows:

(a)EUR 17 200 shall be due at the date of the start of the procedure for the assessment of the draft protocol referred to in Article 107n of Directive 2001/83/EC; from that amount, the remuneration for the rapporteur shall be EUR 7 280, and that remuneration shall be shared, where applicable, between the rapporteur and the co-rapporteur(s);

(b)EUR 25 800 shall be due at the date of the start of the procedure for the assessment of the final study report by the Pharmacovigilance Risk Assessment Committee as referred to in Article 107p of Directive 2001/83/EC; from that amount, the remuneration for the rapporteur shall be EUR 10 920, and that remuneration shall be shared, where applicable, between the rapporteur and the co-rapporteur(s).

2.Where marketing authorisation holders conduct a joint post-authorisation safety study as referred to in Article 5(3), the amount payable by each marketing authorisation holder shall be levied by the Agency by evenly dividing the total amount of the fee among those marketing authorisation holders. Where relevant, the fee reduction laid down in point 3 of this Part or, where appropriate, the fee exemption referred to in Article 1(4), shall be applied to the share payable by the marketing authorisation holder.

3.In application of Article 5(4), small and medium-sized enterprises shall pay 60 % of the applicable amount.

4.Where the fee reduction or the fee exemption applies, the remuneration for the rapporteur and, where applicable, co-rapporteur(s) shall also be adapted proportionally. Where the Agency subsequently collects the full applicable amount, including the 10 % increase as provided for in Article 8(5), the remuneration for the rapporteur and, where applicable, co-rapporteur(s) shall also be adapted proportionally.

PART III

FEE FOR ASSESSMENT IN THE CONTEXT OF REFERRALS INITIATED AS A RESULT OF THE EVALUATION OF PHARMACOVIGILANCE DATA REFERRED TO IN ARTICLE 6

1.The fee for the assessment of the procedure referred to in Article 6(1) shall be EUR 179 000 where one or two active substances and/or combinations of active substances are included in the assessment. That fee shall be increased by EUR 38 800 per each additional active substance or combination of active substances as of the third active substance or combination of substances. That fee shall not exceed EUR 295 400 irrespective of the number of active substances and/or combinations of active substances.

From the amount of the fee, the total amount of remuneration for the rapporteur and the co-rapporteur(s) shall be as follows:

(a)EUR 119 333 where one or two active substances and/or combinations of active substances are included in the assessment;

(b)EUR 145 200 where three active substances and/or combinations of active substances are included in the assessment;

(c)EUR 171 066 where four active substances and/or combinations of active substances are included in the assessment;

(d)EUR 196 933 where five or more active substances and/or combinations of active substances are included in the assessment.

Where one or two active substances and/or combinations of active substances are included in the assessment, the Agency shall remunerate the national competent authorities for the services provided by the rapporteur and co-rapporteur(s) by dividing equally the total amount of the remuneration.

Where three or more active substances and/or combinations of active substances are included in the assessment, the Agency shall remunerate the national competent authorities for the services provided by the rapporteur and co-rapporteur(s) by:

(a)dividing the total amount of the remuneration equally between the national competent authorities; and

(b)subsequently increasing the resulting amount of the remuneration for the rapporteur by EUR 1 000 where three substances and/or combinations of active substances are included, by EUR 2 000 where four substances and/or combinations of active substances are included and by EUR 3 000 where five or more active substances and/or combinations of active substances are included. That increase shall be paid from the parts of the fee attributed to the Agency and the co-rapporteur(s), each of which shall contribute the same amount.

2.For the purpose of calculating the amount to be levied on each marketing authorisation holder in application of Article 6(4), the Agency shall calculate the proportion of chargeable units held by each marketing authorisation holder concerned of the total number of chargeable units held by all marketing authorisation holders involved in the procedure.

The amount payable by each marketing authorisation holder shall be calculated by:

(a)dividing the total amount of the fee among the marketing authorisation holders proportionately to the number of chargeable units; and

(b)subsequently applying the fee reduction laid down in point 4 of this Part and the fee exemption referred to in Article 1(4), where relevant.

Where the fee reduction or the fee exemption applies, the remuneration for the rapporteur and co-rapporteur(s) shall also be adapted proportionally. Where the Agency subsequently collects the full applicable amount, including the 10 % increase as provided for in Article 8(5), the remuneration for the rapporteur and co-rapporteur(s) shall be adapted proportionally.

3.In application of Article 6(5), the amount payable by the marketing authorisation holder shall be two thirds of the applicable fee laid down in point 1 of this Part. Small and medium-sized enterprises shall pay 60 % of that amount.

The total amount of remuneration for the rapporteur and the co-rapporteur(s) from either of the reduced amounts of the fee referred to in the first subparagraph shall correspond to the same proportion as the total amount of remuneration for the rapporteur and the co-rapporteur(s) from the fee laid down in point 1 of this Part for assessments involving one or two active substances and/or combinations of active substances. The Agency shall divide that amount equally between the national competent authorities for the services provided by the rapporteur and the co-rapporteur(s).

4.In application of Article 6(6), small and medium-sized enterprises shall pay 60 % of the applicable amount.

PART IV

ANNUAL FEE FOR INFORMATION TECHNOLOGY SYSTEMS AND LITERATURE MONITORING REFERRED TO IN ARTICLE 7

1.The annual fee shall be EUR 67 per chargeable unit.

2.In application of Article 7(3), small and medium-sized enterprises shall pay 60 % of the applicable amount.

3.Holders of marketing authorisations for medicinal products referred to in Article 7(4) shall pay 80 % of the amount applicable to the chargeable units corresponding to those medicinal products.

PART V

PERFORMANCE INFORMATION

The following information shall relate to each calendar year:

Number of Agency staff involved in pharmacovigilance activities pursuant to Union legal acts applicable during the reference period, specifying staff allocated to activities corresponding to each of the fees referred to in Articles 4 to 7.

Number of hours outsourced to third parties with specification of the activities concerned and cost incurred.

Overall pharmacovigilance costs and a breakdown of staff and non-staff costs relating to activities corresponding to each of the fees referred to in Articles 4 to 7.

Number of procedures relating to the assessment of periodic safety update reports, as well as number of marketing authorisation holders and number of chargeable units per procedure; number of reports submitted per procedure and number of marketing authorisation holders that have submitted a joint periodic safety update report.

Number of procedures relating to the assessment of draft protocols and of final reports of post-authorisation safety studies; number of marketing authorisation holders having submitted a draft protocol; number of marketing authorisation holders having submitted a final study report; number of marketing authorisation holders that have submitted a joint study.

Number of procedures relating to the referrals initiated as a result of the evaluation of pharmacovigilance data as well as number of marketing authorisation holders and number of chargeable units involved per marketing authorisation holder and per procedure.

Number of marketing authorisation holders that have claimed a small and medium-sized enterprise status involved in each procedure; number of marketing authorisation holders whose claim has been denied.

Number of marketing authorisation holders that have claimed a micro enterprise status; number of marketing authorisation holders whose claim for fee exemption has been denied.

Number of marketing authorisation holders of medicinal products referred to in Article 7(4) that have benefitted from reduced annual fees; number of chargeable units per marketing authorisation holder concerned.

Number of invoices sent out and annual fees charged in respect of the annual fee and average and overall amount invoiced to marketing authorisation holders.

Number of marketing authorisation holders that have claimed a small and medium-sized enterprise or a micro enterprise status for each application of the annual fee; number of marketing authorisation holders whose claim has been denied.

Attribution of rapporteurships and co-rapporteurships per Member State per type of procedure.

Number of working hours spent by the rapporteur and the co-rapporteur(s) per procedure on the basis of information provided to the Agency by the national competent authorities concerned.