如何在尼日利亞 nafdac 註冊進口藥物
如何在尼日利亞同 nafdac 一齊註冊一個進口藥物
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, 按照尼日利亞國家食品藥品監督管理和管制署嘅要求, 出口和進口受管制的食品和藥品產品 ("NAFDAC"). 該出版物就如何在尼日利亞向 nafdac 註冊進口藥物提供了見解.
如何在尼日利亞申請進口藥物
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在尼日利亞向 nafdac 註冊進口藥品嘅申請可由製造商或通過其代理人提出, 任命通過 授權書 或 合同製造協議 (在適用的情況下);
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授權書將在原籍國通過 公證;
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註冊申請應包括製造商名稱, 通用名稱, 品牌名稱 (在適用的情況下), 強度, 指示同規定表格上的所有必要信息;
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每項待註冊藥物產品均須提交份單獨的申請表. 在此背景下,, 藥物產品係指一種單獨的藥物配方. 然而, 申請登記份不同強度的劑型, 應當在另一份申請表上提出.
快勞
1. The manufacturer, 在進口藥品嘅情況下 (僅來自印度和中國), 必須提交證據 (製造商證書) 他們獲得了在原產國製造銷售藥品的許可. 呢啲證據必須由製造國的主管衞生局簽發.
2. There must be evidence that the drug product is manufactured according to Good Manufacturing Practice (Gmp).
3. There must be evidence by the competent Health Authority that the sale of the product does not constitute a contravention of the drug laws of that country (即. 醫藥產品證書 (Copp) 符合 边个 格式).
· The documents in respect of 1-3 shall be authenticated by the Nigerian Mission in that country. In countries where no Nigerian Embassy or High Commission exists, 任何英聯邦或西非國家的任何其他大使館或高級委員會都可以進行同樣嘅認證.
4. The applicant shall submit two (2) 根據原子能機構嘅格式製作的檔案材料.
5. 品牌名稱的商標批准證據 從尼日利亞聯邦商務部應提交.
6. Copy of current Annual Licence to Practice as a Pharmacist for the Superintendent Pharmacist issued by Pharmacists Council of Nigeria should be submitted.
7. Copy of Current Certificate of Registration Retention of Premises issued by Pharmacists Council of Nigeria
8. Comprehensive Certificate of analysis of the batch of product submitted for registration processing shall be submitted.
產品
1. A drug product shall not be manufactured in Nigeria, 除非工廠接受檢查，並且認可證書由NAFDAC頒發.
2. In the case of an imported new drug substance, 必須有證據表明，有限嘅本地臨床試驗已經進行, 該產品喺原產国註冊，也, 假假地. 2 或更發達囯傢.
3. No combination drug product shall be registered or considered for registration unless there is proven evidence that such a product has clinical advantage over the single drug available for the same indication(s).
4. The application should indicate the class or type of registration required – 是否為 僅限處方 產品或在櫃枱上.
5. Product found to be of doubtful, 好少或者根本冇治療價值, 不得考慮登記.
6. An applicant shall not be allowed to register a formulation in more than one brand name even where different doses of the active ingredient(s) 使用.
7. All dosage forms of a particular brand name must contain the same active ingredient(s) 或至少主要活性成分(s)
. G。. A cream – Betamethasone 10mg
肥皂 – Betamethasone 20mg
標籤
1. Labelling shall be informative, 清晰準確.
2. Minimum requirements on the package label in accordance with the drug labeling regulations should be:
a) Name of medicine (品牌名稱) 適用和通用名稱緊嘅情況下.
B) Name and full location address of the manufacturer.
C) Provision for NAFDAC Registration Number on product label.
D) Batch No., 製造日期和到期日期. (e) 劑型 & 強度
e) Indications, 頻率, 路線, 管理條件.
F) Dosage regimen on the package (只有当冇隨附嘅傳單插入時，Otc藥物.
G) Leaflet insert, 如果處方產品和醫院包.
H) Net content of product.
我) Quantitative listing of all the active ingredients per unit dose. (K) Adequate warnings where necessary.
3. Where a brand name is used, 必須有通用名稱，應該喺字符上突出, 直接寫喺品牌名稱的，例如:-
文托林片劑
"萨尔布塔沃尔"
4. Any drug product whose name or package label bears close resemblance to an already registered product or is likely to be mistaken for such registered product, 不得考慮註冊.
5. Any drug product which is labeled in a foreign language shall 唔係. 除非標籤和包裝插入中包括英文翻譯，否則考慮進行註冊 (在適用的情況下).
關稅
所有關稅都按規定.
時間表
由提交樣品到發出註冊號嘅產品註冊時間表為一百 (100) 工作日. 然而, 取決於申請人嘅滿意遵守.
要注意的重要事項
1. Registration of a product does not automatically confer Advertising permit. 如果要宣傳產品，應需獲得該機構嘅單獨批准.
2. NAFDAC may withdraw the certificate of Registration in the event that the product is advertised without express approval from the Agency.
3. nafdac 保留撤銷的權利, 證書在有效期內暫停或更改.
4. Filling an application form or paying for an application form does not confer registration status.
5. Failure to respond promptly (在 30 工作日) 查詢有關申請的查詢, 將自動導致暫停進一步處理申請.
6. A successful application attracts a Certificate of Registration with a validity period of five (5) 年.