尼日利亞國家藥品管理局倉庫檢查指南

尼日利亞NAFDAC倉庫檢查指南

Lex Artifex LLP, 尼日利亞律師樓, 有引入 f&d 幫助協助參與製造嘅人同公司, 分布, 出口, 和進口受管制的食品和藥品, 以滿足尼日利亞國家食品藥品監督管理署規定的要求 ("NAFDAC"). 本出版物概述了國家食品藥品監督管理局食品藥品倉庫檢查的監管指南.

倉庫檢驗係簽發化學進口許可證或上市證書嘅先決條件 (授權銷售化學品).

步 1

· A formal application by the company must be made for warehouse inspection

· The letter of application must include the names of the chemicals, 化學品嘅量同用途.

· The Application must be signed by Managing Director/CEO or the Technical Officer of the company.

尼日利亞NAFDAC倉庫檢查所需嘅文件

需要以下文件:

1. Evidence of company registration

2. Certified true copy of Memorandum and Articles of Association of the company.

3. Evidence of particulars of directors of the company

4. Two (2) 護照背面寫有姓名和公司名稱嘅技術官員護照照片.

5. Evidence of the appointment letter, 錄取通知書, 技術幹事嘅資歷.

6. Standard Operating Procedure (Sop) 用于由總經理/首蓆執行官或技術官員正式簽署嘅化學品嘅儲存/處理，名稱同名稱.

7. Evidence of payment for Warehouse inspection.

8. Evidence of payment of rent for a minimum of one year or evidence of ownership in case of companies using their own warehouse.

9. Evidence of previous Listing Certificate. (不適用於新申請人)

10. 以往化學品進口許可證證明進口和許可證嘅清除 (不適用於新申請人).

11. 銷售證據 (發票) 同本地購買. (不適用於新申請人)

12. 庫存和處置記錄. (不適用於新申請人)

13. 廢物處理的證據

14. 指示完整聯繫人地址嘅客戶列表 (冇P. o. 箱), 電話, 電子郵件和狀態 (營銷人員或最終用戶). (在適用的情況下)

15. 技術人員體檢郃格証 (應該每半年做一次).

步 2

· Submission of application and review of documents

透過預約 法律代表同律師, 莱克斯·阿蒂菲克斯律師事務所可以幫助食品和藥品製造商, 出口商, 進口商和分銷商向尼日利亞有關當局提交申請和所有相關文件.

步 3

· Warehouse Inspection as scheduled.

步 4

· Processing of Permit

對倉庫進行滿意檢查後, 申請的許可證已處理.

對於唔令人滿意嘅檢查, A合規指令喺兩個範圍內發佈 (2) 工作日.

· Payment of the prescribed tariff

TIMELINES FOR WAREHOUSE INSPECTION BY NIGERIA’S NAFDAC

· A processing period of fifteen (15) 應允許自提交申請之時起工作日.

· The timeline for processing is suspended when there is a compliance directive and shall resume when the applicant complies and communicates compliance with the Agency.

· Warehouse Inspection is conducted annually for importers and marketers of restricted and agrochemicals. 它進行每 2 工業和實驗室化學品進口商和營銷人員嘅年數.

· Timeline stops once compliance directive is issued.

所有文件必須使用英文.

REGULATORY REQUIREMENTS FOR WAREHOUSE INSPECTION BY NIGERIA’S NAFDAC

• 人員

1. A technical officer with scientific background with a minimum of Ordinary National Diploma; OND及其同等人員應負責解釋和討論提交申請嘅項目的確切化學性質同使用. 佢仲負責化學品嘅處理同儲存.

2. The Technical officer must be present during inspection of facility and must be the officer whose passport photograph was submitted.

3. No technical officer is allowed to represent more than one company (子公司包括).

4. Companies with foreign technical officers must submit work permit.

• 設施

位置

1. Storage and handling of chemicals in residential buildings and or area is prohibited

2. Applicants shall have a warehouse that will be inspected for adequacy and appropriateness for the storage of chemicals.

3. The facility provided will depend on the nature of the chemicals stored.

4. Commercial warehouses are not allowed for storage of restricted and agrochemicals.

存儲

1. The facilities provided will depend on the nature of the chemicals in the warehouse. 某些化學品需要喺受控條件下儲存 (低於環境) 溫度，以維持其有效有效期.

2. Companies that intend to store thermo-labile (熱敏) 化學品應提供冷室/冰箱, 冷箱或冷氣機房，視所需溫度.

3. Other facilities required for chemical storage include adequate illumination, 通風, 提供托盤, 急救設施, 個人防護裝備, 同滅火器.

4. Chemicals should be stacked on pallets away from the walls with adequate space for movement within the warehouse. 應相應地使用狀態標籤.

5. Food grade chemicals or pharmaceutical raw materials should be separated from industrial chemicals.

6. Expired, 過時或損壞的化學品應分開, 隔離, 記錄並報告畀原子能機構.

7. Flammable chemicals should not be stored close to sources of ignition or sparks.

8. Chemicals that can be easily oxidized should be kept away from oxidizing agents.

化學品標籤信息

1. All Chemicals should be properly labeled according to the Globally Harmonized System (Ghs) 化學品嘅標籤同分類.

2. Chemicals should be labeled in English and should include but not limited to the following-Brand/Generic name, 批號, 生產日期和到期日期, 製造商的名稱和地址, 危險符號, 原籍國, 淨內容重量, 粘度, 比重, 易燃, 純度百分比.

安全要求

1. Personnel are to be provided with nose masks, 手手套, 護目鏡, 工作服, 同安全靴.

2. Appropriate water supply should be in place.

3. First aid box and fire extinguishers are to be placed at strategic locations.

4. Condition monitoring devices are to be provided for sensitive chemicals.

5. 快勞

6. Companies should keep proper records of chemicals imported, 在當地出售和購買

7. (處置/使用記錄).

8. Disposal records of expired chemicals should also be kept with a certificate of destruction issued by authorized agencies.

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lex artifex llp 係製造商嘅窗口, 出口商, 同受管制食品和藥品產品的經銷商在尼日利亞尋求許可證, 並尋求進入尼日利亞市場. 我哋係一站式服務 在尼日利亞的法律合規性和盡職調查服務. 我哋透過貿易流程嘅每一步及以後為客戶提供法律指導.

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