世界杯-智利注册文件清单英文版

毒手药王

【世界杯和制药】智利注册文件清单英文版

SUMMARY OF LEGAL, SCIENTIFIC AND TECHNICAL INFORMATION FOR REGISTRATION IN CHILE OF
PRODUCTS MANUFACTURED IN FOREIGN COUNTRIES  
1   LEGAL DOCUMENTS
ALL LEGAL DOCUMENTS MUST BE LEGALIZED BY A PUBLIC NOTARY AND BY THE CHILEAN CONSULATE NEAREST TO YOUR ADDRESS.  
A)   PRODUCS UNDER A TOLL AGREEMENT
  Includes semi-manufactured, manufactured in bulk and finished products.  
a.1   Manufacturing Agreement.
This document may be issued for one product or for a group of products. Also, the agreement can indicate the complete quantitative/qualitative formula or it can indicate the generic name of the product(s). It must also indicate the pharmaceutical form and the unit dosage. In case of including the formula, this must declare per unit dosage for the solid or injectable forms, or the percentage in the case of liquid or inhaler forms. In the particular case of extemporary solutions or suspensions, they must also be declared in their percentage form, but related to the powder or grains without reconstitution.  
a.2   Certificate issued by the local health authorities stating that the involved company is authorized for the manufacture of pharmaceutical products for human use.  
a.3   Certificate issued by the local health authorities certifying that the manufacturer complies with the GMP (this statement can be included in the above certificate).  
2.   SCIENTIFIC AND TECHNICAL DOCUMENTS  
A   SIMILAR PRODUCTS: those already registered in Chile.  
a.1   Qualitative/quantitative formula. It must include, separately, the composition of active principles, excipients, dyes, coating, capsule, etc.

a.2   Specification of the raw materials, both active and excipients.

a.3   Specifications of the finished product, including, when necessary, the following:  
a.3.1   Physical: aspect, weight, hardness, dimensions, density, viscosity, dissolution, desintegration, etc.  
a.4   Analytical Method of active principles, and finished product. Analytical method of excipients when they are not included in the following pharmacopeias: North American (UPS), British (BP) or European.
a.5   Samples of finished product in the amount sufficient for registration and analysis. Each registration requires three samples of final presentation and the analysis requires, in general and depending on the product, 100 - 150 capsules, tablets or suppositories, and 5 to 10 bottles of the liquid pharmaceutical forms, depending on the volume of them.  
a.6   Standards of Active Principles and of Degradation products, when necessary.  
a.7   Specifications of the packing material. In the case of a finished product it is necessary to specify the packing material, both primary (the one in contact with the pharmaceutical form) and secondary (external). This refers to the type and composition of the material (i.e. blister-pack formed by aluminium foil and PVC).  
In the case of products manufactured in bulk, to be imported packed in primary packing (blister-pack, bottles, vials, etc.), to be packed and labelled in Chile, the specifications related to the size of the labels and boxes must also be sent.  
a.8   Stability study of the product(s). It must be carried out with the product already packed and it can be accelerated or from shelf-life, according to ICH standards.  
a.9   Sterility and bacterial endotoxines or pirogenes essays, in the case of injectable products.  
B   NEW PRODUCTS: Those that are not still registered in Chile.  
b.1   Qualitative/quantitative formula. It must be include, separately, the composition of active principles, excipients, dyes, coating, capsules, etc.

b.2   Specifications of the raw materials, both active and excipients.

b.3   Specifications of the finished product. They shall include, when necessary:  
b.3.1   Physical: aspect, weight, hardness, dimen-       sions, density, viscosity, dissolution, de-     gradation, etc.  
b.3.2   Chemical: contents of active principle (va-     luation, variation of contents,   impurity     contents, solvents remainders, etc.

b.4   Analytical Method of Active principles and finished product. Analytical method of excipients when they are not included in the following pharmacopeias: North American (UPS), British (BP) or European.

b.5   Samples of finished products in the amount sufficient for registration and analysis. Each registration requires three samples of final presentation and the analysis requires, in general and depending on the product, 100 - 150 capsules, tablets or suppositories, and 5 to 10 bottles of the liquid pharmaceutical forms, depending on the volume of them.  
b.6   Standards of Active Principles and Degradation products, when necessary.  
b.7   Specification of the packing material. In the case of a finished product it is necessary to specify the packing material, both primary (the one in contact with the pharmaceutical form), as well as secondary (external). This refers to the type and composition of the material (i.e. blister-pack formed by aluminium folia and PVC).  
In the case of products manufactured in bulk, to be imported packed in primary packing (blister-pack, bottles, vials, etc.), to be packed and labelled in Chile, the specifications related to the size of the labels and boxes must also be sent.  

6.8   Stability Study of the product(s). It must be carried out with the product in its packing procedures and it can be accelerated or from the shelf and according to ICH standards.

仲夏秋夜云

毒手师傅，你是大师啊~

毒手药王

仲夏秋夜云 发表于 2014-6-11 12:06
毒手师傅，你是大师啊~

偶然搜到的。

毛毛球

看不懂哦..............

依恋

您好，想向您请教智利关于药品法规的网站，谢谢。