
REGULATION (EU) No 658/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (Text with EEA relevance) (revoked) 

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Subject matter and scope
Article 1 
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Definitions
Article 2 
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Types of fees
Article 3 
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Fee for assessment of periodic safety update reports
Article 4 
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Fee for assessment of post-authorisation safety studies
Article 5 
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Fee for assessments in the context of referrals initiated as a result of the evaluation of pharmacovigilance data
Article 6 
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Annual fee for information technology systems and literature monitoring
Article 7 
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Fee reductions and fee exemption
Article 8 
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Payment of remuneration by the Agency to national competent authorities
Article 9 
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Method of payment of the fee
Article 10 
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Identification of the payment of the fee
Article 11 
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Date of payment of the fee
Article 12 
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Refund of fee amounts paid in excess
Article 13 
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Provisional estimate of Agency budget
Article 14 
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Transparency and monitoring
Article 15 
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Exercise of the delegation
Article 16 
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Transitional provisions
Article 17 
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Entry into force and application
Article 18 
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ANNEX
PART I
FEE FOR ASSESSMENT OF PERIODIC SAFETY UPDATE REPORTS REFERRED TO IN ARTICLE 4
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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. 

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3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 
                        45 810 to be paid in two instalments as follows: 

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2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 
                        190 740 where one or two active substances and/or combinations of active substances are included in the assessment. That fee shall be increased by EUR 
                        41 350 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 
                        314 790 irrespective of the number of active substances and/or combinations of active substances. 

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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. 

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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. 

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4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART IV
ANNUAL FEE FOR INFORMATION TECHNOLOGY SYSTEMS AND LITERATURE MONITORING REFERRED TO IN ARTICLE 7
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART V
PERFORMANCE INFORMATION
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