How to register an imported drug with NAFDAC in Nigeria HOW TO REGISTER AN IMPORTED DRUG WITH NAFDAC IN NIGERIA Lex Artifex LLP, 律师事务所在尼日利亚, 先后引进歼&d服务台,协助参与制造的个人和公司, 分配, 出口和管制的食品和药品进口的产品在满足尼日利亚国家局食品和药品管理控制设置的要求 (“NAFDAC”). 本出版物提供了有关如何在尼日利亚NAFDAC注册的进口药品的见解. HOW TO APPLY TO REGISTER AN IMPORTED DRUG WITH NAFDAC IN NIGERIA Application to register an imported drug product with NAFDAC in Nigeria can be made by the manufacturer or through his agent, appointed through a Power of Attorney or Contract Manufacturing Agreement (where applicable); The Power of Attorney is to be notarized in the country of origin by a Notary Public; 对于登记申请,应当包括制造商的名称, 通用名, brand name (where applicable), 强度, 指示和对规定的形式的所有必需的信息; 单独的应用程序的形式被提交给每种药物产品被注册. 在此背景下, 药物产品是指一个单独的药物制剂. However, 对于具有不同的优势一种剂型的登记申请应的单独的应用表格提出. 文档 1.    The manufacturer, 在进口药品的情况下 (来自印度和中国唯一), 必须提交证据 (制造商证书) 他们被授权生产药品销售在原产国. 这些证据必须由卫生主管机关在制造国家发行. 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. 药剂制品证明书 (COPP) that conforms to WHO format). ·         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, 任何联邦或西非国家的任何其他使馆或高级专员公署可以验证同样的. 4.    The applicant shall submit two (2) 档案按照该机构的格式做出来的. 5.    Evidence of Trade Mark Approval for brand name from Federal Ministry of Commerce in Nigeria should be submitted. 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. 产品 1.    A drug product shall not be manufactured in Nigeria, 除非工厂检验和认可的证书是由NAFDAC颁发. 2.   In the case of an imported new drug substance, 必须有证据表明,当地有限的临床试验已经进行, 而这种产品是注册在来源和也的国家, 至少在 2 或较发达的国家. 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(s). 4.    The application should indicate the class or type of registration required - whether a prescription only product or Over the Counter. 5.    Product found to be of doubtful, 很少或没有治疗价值的,不得视为对注册. 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) 或至少主要的活性成分(s) E.g. A cream         -   小号    Betamethasone 10mg                A soap -       Betamethasone 20mg LABELLING 1.    Labelling shall be informative, 清晰准确. 2.    Minimum requirements on the package label in accordance with the drug labeling regulations should be: 一个)     Name of medicine (brand name) 在适用和通用名. b)     Name and full location address of the manufacturer. C)      Provision for NAFDAC Registration Number on product label. d)     Batch No., 生产日期和失效日期. (Ë)       剂型 & strength e)     Indications, 频率, 路线, 管理的条件. F)       Dosa品牌 on the package (非处方药仅如果没有伴随单张插入. G)      Leaflet insert, 如果处方药和医院包. 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, 有必须是在性质上应该显眼的通用名称, 直属品牌的名字写例如:- VENTOLIN TABLETS “SALBUTAMOL” 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, 不得被视为登记. 5.      Any drug product which is labeled in a foreign language shall NOT be considered for registration unless an English translation is included on the label and package insert (where applicable). TARIFF All tariffs are as prescribed.  TIMELINE The timeline for product registration from submission of samples up to the issuance of the registration number is hundred (100) work days. However, 这依赖于良好的合规申请人. 重要注意事项 1.    Registration of a product does not automatically confer Advertising permit. 该机构的单独审批应要求如果产品要发布. 2.    NAFDAC may withdraw the certific适用ion in the event that the product is advertised without express approval from the Agency. 3.    NAFDAC保留撤销权, 然而在其有效期内改变证书. 4.    Filling an application form or paying for an application form does not confer registration status. 5.    Failure to respond promptly (内 30 work days) 要查询的查询应用提出, 将自动导致悬浮液中的应用的进一步处工作日.    A successful application attracts a Certificate of Registration with a validity period of five (5) 年份. 关于LEX ARTIFEX LLP莱克斯ARTIFEX LLP是厂家的窗口, 出口商, 和监管食品和药品寻求在尼日利亚许可和寻求进入尼日利亚市场经销商. 我们是合法合规性和尽职调查服务在尼日利亚一站式服务. 我们通过贸易过程中和以后的每一步提供法律指导客户.  To learn more about the Lex Artifex LLP's F&D Helpdesk and how we can help you with the registration of your pharmaceutical products in Nigeria, 请发邮件: lexartifexllp@lexartifexllp.com; 呼叫 +234.803.979.5959.

如何在尼日利亚NAFDAC注册的进口药品

如何注册进口药品与NAFDAC尼日利亚

Lex Artifex LLP, 律师事务所在尼日利亚, 先后引进歼&d服务台,协助参与制造的个人和公司, 分配, 出口和管制的食品和药品进口的产品在满足尼日利亚国家局食品和药品管理控制设置的要求 (“NAFDAC”). 本出版物提供了有关如何在尼日利亚NAFDAC注册的进口药品的见解.

如何申请注册一个进口药品与NAFDAC尼日利亚

  • 可以由制造商或通过代理人进行登记与NAFDAC尼日利亚的进口药品申请, 通过任命 授权书 要么 合同制造协议 (适用);
  • 授权书是由在原产国进行公证 公证人;
  • 对于登记申请,应当包括制造商的名称, 通用名, 品牌 (适用), 强度, 指示和对规定的形式的所有必需的信息;
  • 单独的应用程序的形式被提交给每种药物产品被注册. 在此背景下, 药物产品是指一个单独的药物制剂. 然而, 对于具有不同的优势一种剂型的登记申请应的单独的应用表格提出.

文档

1. The manufacturer, 在进口药品的情况下 (来自印度和中国唯一), 必须提交证据 (制造商证书) 他们被授权生产药品销售在原产国. 这些证据必须由卫生主管机关在制造国家发行.
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. 药剂制品证明书 (COPP) 符合 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, 任何联邦或西非国家的任何其他使馆或高级专员公署可以验证同样的.
4. The applicant shall submit two (2) 档案按照该机构的格式做出来的.
5. 商标批准的证据品牌名称 来自商务部的联邦尼日利亚应提交.
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.

产品

1. A drug product shall not be manufactured in Nigeria, 除非工厂检验和认可的证书是由NAFDAC颁发.
2. In the case of an imported new drug substance, 必须有证据表明,当地有限的临床试验已经进行, 而这种产品是注册在来源和也的国家, 至少在 2 或较发达的国家.
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(小号).
4. The application should indicate the class or type of registration required – 是否 只有处方 产品或柜台.
5. Product found to be of doubtful, 很少或没有治疗价值的,不得视为对注册.
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(小号) 使用.
7. All dosage forms of a particular brand name must contain the same active ingredient(小号) 或至少主要的活性成分(小号)
E.g. A creamBetamethasone 10mg
肥皂 – Betamethasone 20mg

贴标

1. Labelling shall be informative, 清晰准确.
2. Minimum requirements on the package label in accordance with the drug labeling regulations should be:
一个) Name of medicine (品牌) 在适用和通用名.
b) Name and full location address of the manufacturer.
C) Provision for NAFDAC Registration Number on product label.
d) Batch No., 生产日期和失效日期. (Ë) 剂型 & 强度
Ë) Indications, 频率, 路线, 管理的条件.
F) Dosage regimen on the package (非处方药仅如果没有伴随单张插入.
G) Leaflet insert, 如果处方药和医院包.
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, 有必须是在性质上应该显眼的通用名称, 直属品牌的名字写例如:-
VENTOLIN片剂
“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, 不得被视为登记.
5. Any drug product which is labeled in a foreign language shall 考虑注册,除非英语翻译包含在标签和包装说明书 (适用).

关税

所有关税规定.

时间线

用于产品注册从提交样品到发行的注册号码的时间轴是百 (100) 工作日. 然而, 这依赖于良好的合规申请人.

重要注意事项

1. Registration of a product does not automatically confer Advertising permit. 该机构的单独审批应要求如果产品要发布.
2. NAFDAC may withdraw the certificate of Registration in the event that the product is advertised without express approval from the Agency.
3. NAFDAC保留撤销权, 暂停或在其有效期内改变证书.
4. Filling an application form or paying for an application form does not confer registration status.
5. Failure to respond promptly (内 30 工作日) 要查询的查询应用提出, 将自动导致悬浮液中的应用的进一步处理的.
6. A successful application attracts a Certificate of Registration with a validity period of five (5) 年份.

 

关于LEX ARTIFEX LLP

莱克斯ARTIFEX LLP是厂家的窗口, 出口商, 和监管食品和药品寻求在尼日利亚许可和寻求进入尼日利亚市场经销商. 我们是一个一站式服务 在尼日利亚法律合规和尽职调查服务. 我们通过贸易过程中和以后的每一步提供法律指导客户.
要了解更多关于莱克斯ARTIFEX LLP的食品 & 药物 (F&d) 服务台以及我们如何可以帮助您与您的医药产品在尼日利亚注册, 请发邮件: lexartifexllp@lexartifexllp.com; 呼叫 +234.803.979.5959.