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EU GMP certification requirements
browse: Release date:2017-07-21
European Union (EU) is one of the world's largest and most important pharmaceutical international mainstream markets. Because "the nearly 30 members of GMP certification / inspection (GMP Inspection)" is the mutual recognition of each other / share the results, but also with the United States, Japan, Australia and Canada share inspection results, which makes the European Union GMP certification / inspection on a global scale is more and more big.
 
In recent years, more and more Chinese pharmaceutical companies begin to apply for and obtain the EU GMP certification, the main reasons and significance include:
1. access to EU GMP certification is the basic condition for products to enter the EU's nearly 600 million large population market;
2. is to obtain the European Union countries and other countries "contract / Contract/Custom Manufacture production" the necessary condition;
3. is the embodiment of international GMP management level;
4. is to improve the enterprise GMP management level of effective means;
5. is a clear condition for China's preferential policies.
 Authentication procedure
In principle, the European GMP certification is associated with the "drug", the EU or its member countries does not have an independent GMP certification / inspection procedures, the EU GMP certification must have a program to start the application (Trigger)".
   (一) for the pharmaceutical manufacturers, the "startup" procedures for the GMP certification examination are mainly:
1. EU drug listing permit application (MAA)";
2. import drugs through EU importers to the European union;
3. acceptance of contract / custom production by European pharmaceutical companies";
4. become an overseas production plant of European pharmaceutical companies.
 
(二) for the raw material pharmaceutical manufacturers, the "startup" process mainly consists of:
1. Application for certificate of suitability (CEP/COS) of European pharmacopoeia;
2. to be the API supplier of pharmaceutical products listed in the European union;
That is to say, in order to obtain the GMP certification examination of the EU or its member countries, the Chinese company must select at least one of these procedures.
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