大不列顛製造活性物質出口EEA及北愛爾蘭書面確認

1. 發布細節

更新於2025年1月2日。依開放政府許可v3.0條款授權。 https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain

2. 書面確認目的

書面確認確認第三國出口活性物質至EEA：良好製造實務（GMP）標準等同EU/EEA；製造廠接受定期檢查（可宣布及未宣布）；重大不合規事件將無延遲通報EEA。書面確認模板可於歐盟委員會網站找到。 https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain 書面確認要求載於2001/83/EC指令第46b(2)(b)條。 https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain

3. 大不列顛（英格蘭、威爾斯及蘇格蘭）活性物質製造商「第三國」地位

大不列顛被認第三國出口人類用活性物質至EEA。北愛爾蘭活性物質製造商將繼續被EEA認。書面確認將需每一大不列顛製造活性物質出口EEA及北愛爾蘭出貨。 https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain

4. 英國製造活性物質書面確認產生

無需提供MHRA任何資訊允許產生書面確認。書面確認所需所有資訊於MHRA系統可用。書面確認將產生大不列顛活性物質製造商無論是否意圖出口活性物質。 https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain

4.1 生物產品

生物活性物質製造視生物藥品部分製造。此活動記錄於英國製造授權（MIA）第1.3節及滿意檢查後發行相關GMP證書。若持有包括生物活性物質製造MIA，活性物質製造商單獨註冊不需。無書面確認發行，此已MHRA GMP證書確認。 https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain

5. 其他第三國製造活性物質書面確認取得

取得其他「第三國」活性物質進口書面確認要求無變更。仍需從該國發行機關取得書面確認。北愛爾蘭製造活性物質供應大不列顛無需書面確認。 https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain

6. 活性物質分銷商要求

若活性物質分銷商未製造，書面確認將不產生其活動。若出口活動需書面確認，可從適當發行機關或直接製造商取得。 https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain

7. 書面確認有效期

書面確認有效期同對應GMP證書。若需MHRA將提供大不列顛活性物質製造地點GMP證書重新發行評估，2021年1月1日前，允許產生適當有效期書面確認。 https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain

8. 每一出口EEA及北愛爾蘭活性物質出貨書面確認提供

EU書面確認期望問答文件可於歐盟委員會網站取得。此文件識別如何提供書面確認EEA內客戶。 https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain

9. 機密GMP證書公司

若公司因製造活性物質性質有機密GMP證書，書面確認將不發布MHRA網站。書面確認將發送活性物質註冊命名聯絡人。 https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain

10. GMP證書及書面確認兩者要求

雖GMP證書及書面確認含類似資訊，兩文件服務不同目的：英國法要求檢查後發行GMP證書；EU法規要求第三國任何活性物質進口EEA需書面確認。若出口大不列顛製造活性物質至EEA或北愛爾蘭，因此需有效GMP證書及有效書面確認。 https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain

11. 書面確認持續要求

書面確認需求預期臨時位置。將申請認大不列顛活性物質製造GMP標準等同EU。一旦國家被接受有等同GMP標準，加入「白名單」書面確認不再需。 https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain