如何在尼日利亞NAFDAC註冊的進口藥品
如何註冊進口藥品與NAFDAC尼日利亞
Lex Artifex LLP, 律師事務所在尼日利亞, 先後引進殲&d服務台，協助參與製造的個人和公司, 分配, 出口和管制的食品和藥品進口的產品在滿足尼日利亞國家局食品和藥品管理控制設置的要求 (“NAFDAC”). 本出版物提供了有關如何在尼日利亞NAFDAC註冊的進口藥品的見解.
如何申請註冊一個進口藥品與NAFDAC尼日利亞
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可以由製造商或通過代理人進行登記與NAFDAC尼日利亞的進口藥品申請, 通過任命 授權書 要么 合同製造協議 (適用);
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授權書是由在原產國進行公證 公證人;
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對於登記申請，應當包括製造商的名稱, 通用名, 品牌 (適用), 強度, 指示和對規定的形式的所有必需的信息;
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單獨的應用程序的形式被提交給每種藥物產品被註冊. 在此背景下, 藥物產品是指一個單獨的藥物製劑. 然而, 對於具有不同的優勢一種劑型的登記申請應的單獨的應用表格提出.
文檔
1. The manufacturer, 在進口藥品的情況下 (來自印度和中國唯一), 必須提交證據 (製造商證書) 他們被授權生產藥品銷售在原產國. 這些證據必須由衛生主管機關在製造國家發行.
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. 藥劑製品證明書 (COPP) 符合 誰 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, 任何聯邦或西非國家的任何其他使館或高級專員公署可以驗證同樣的.
4. The applicant shall submit two (2) 檔案按照該機構的格式做出來的.
5. 商標批准的證據品牌名稱 來自商務部的聯邦尼日利亞應提交.
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, 除非工廠檢驗和認可的證書是由NAFDAC頒發.
2. In the case of an imported new drug substance, 必須有證據表明，當地有限的臨床試驗已經進行, 而這種產品是註冊在來源和也的國家, 至少在 2 或較發達的國家.
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(小號).
4. The application should indicate the class or type of registration required – 是否 只有處方 產品或櫃檯.
5. Product found to be of doubtful, 很少或沒有治療價值的，不得視為對註冊.
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(小號) 使用.
7. All dosage forms of a particular brand name must contain the same active ingredient(小號) 或至少主要的活性成分(小號)
E.g. A cream – Betamethasone 10mg
肥皂 – Betamethasone 20mg
貼標
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:
一個) Name of medicine (品牌) 在適用和通用名.
b) Name and full location address of the manufacturer.
C) Provision for NAFDAC Registration Number on product label.
d) Batch No., 生產日期和失效日期. (Ë) 劑型 & 強度
Ë) Indications, 頻率, 路線, 管理的條件.
F) Dosage regimen on the package (非處方藥僅如果沒有伴隨單張插入.
G) Leaflet insert, 如果處方藥和醫院包.
H) Net content of product.
一世) Quantitative listing of all the active ingredients per unit dose. (ķ) Adequate warnings where necessary.
3. Where a brand name is used, 有必須是在性質上應該顯眼的通用名稱, 直屬品牌的名字寫例如:-
VENTOLIN片劑
“沙丁胺醇”
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, 不得被視為登記.
5. Any drug product which is labeled in a foreign language shall 不 考慮註冊，除非英語翻譯包含在標籤和包裝說明書 (適用).
關稅
所有關稅規定.
時間線
用於產品註冊從提交樣品到發行的註冊號碼的時間軸是百 (100) 工作日. 然而, 這依賴於良好的合規申請人.
重要注意事項
1. Registration of a product does not automatically confer Advertising permit. 該機構的單獨審批應要求如果產品要發布.
2. NAFDAC may withdraw the certificate of Registration in the event that the product is advertised without express approval from the Agency.
3. NAFDAC保留撤銷權, 暫停或在其有效期內改變證書.
4. Filling an application form or paying for an application form does not confer registration status.
5. Failure to respond promptly (內 30 工作日) 要查詢的查詢應用提出, 將自動導致懸浮液中的應用的進一步處理的.
6. A successful application attracts a Certificate of Registration with a validity period of five (5) 年份.