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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)

EU Regulation No 658/2014 · Adopted 15 May 2014 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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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Annotations to the whole text

Textual amendments

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Regulation revoked (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(dd) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)

Contents

  1. 1Subject matter and scope Repealed
  2. 2Definitions Repealed
  3. 3Types of fees Repealed
  4. 4Fee for assessment of periodic safety update reports Repealed
  5. 5Fee for assessment of post-authorisation safety studies Repealed
  6. 6Fee for assessments in the context of referrals initiated as a result of the evaluation of pharmacovigilance data Repealed
  7. 7Annual fee for information technology systems and literature monitoring Repealed
  8. 8Fee reductions and fee exemption Repealed
  9. 9Payment of remuneration by the Agency to national competent authorities Repealed
  10. 10Method of payment of the fee Repealed
  11. 11Identification of the payment of the fee Repealed
  12. 12Date of payment of the fee Repealed
  13. 13Refund of fee amounts paid in excess Repealed
  14. 14Provisional estimate of Agency budget Repealed
  15. 15Transparency and monitoring Repealed
  16. 16Exercise of the delegation Repealed
  17. 17Transitional provisions Repealed
  18. 18Entry into force and application Repealed
  19. Signature
  20. Annex Repealed
  21. Part I: FEE FOR ASSESSMENT OF PERIODIC SAFETY UPDATE REPORTS REFERRED TO IN ARTICLE 4 Repealed
  22. 1Division 1 Repealed
  23. 2For 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. Repealed
  24. 3Division 3 Repealed
  25. 4Division 4 Repealed
  26. Part II: FEE FOR ASSESSMENT OF A POST-AUTHORISATION SAFETY STUDIES REFERRED TO IN ARTICLE 5 Repealed
  27. 1The fee for the assessment of each post-authorisation safety study shall be EUR 45 810 to be paid in two instalments as follows: Repealed
  28. 2Division 2 Repealed
  29. 3Division 3 Repealed
  30. 4Division 4 Repealed
  31. 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 Repealed
  32. 1The 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. Repealed
  33. 2For 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. Repealed
  34. 3In 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. Repealed
  35. 4Division 4 Repealed
  36. Part IV: ANNUAL FEE FOR INFORMATION TECHNOLOGY SYSTEMS AND LITERATURE MONITORING REFERRED TO IN ARTICLE 7 Repealed
  37. 1Division 1 Repealed
  38. 2Division 2 Repealed
  39. 3Division 3 Repealed
  40. VPERFORMANCE INFORMATION Repealed

1Subject matter and scopeF1

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2DefinitionsF1

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3Types of feesF1

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4Fee for assessment of periodic safety update reportsF1

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5Fee for assessment of post-authorisation safety studiesF1

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6Fee for assessments in the context of referrals initiated as a result of the evaluation of pharmacovigilance dataF1

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7Annual fee for information technology systems and literature monitoringF1

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8Fee reductions and fee exemptionF1

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9Payment of remuneration by the Agency to national competent authoritiesF1

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10Method of payment of the feeF1

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11Identification of the payment of the feeF1

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12Date of payment of the feeF1

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13Refund of fee amounts paid in excessF1

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14Provisional estimate of Agency budgetF1

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15Transparency and monitoringF1

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16Exercise of the delegationF1

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17Transitional provisionsF1

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18Entry into force and applicationF1

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Signature

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1F1

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2For 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.F1

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3F1

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4F1

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1The fee for the assessment of each post-authorisation safety study shall be EUR 45 810 to be paid in two instalments as follows:F1

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2F1

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3F1

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4F1

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1The 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.F1

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2For 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.F1

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3In 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.F1

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4F1

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1F1

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2F1

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3F1

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VPERFORMANCE INFORMATIONF1

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