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Date: 28 December 2011 Registration in China Project: Imported Feed, Feed Additive and Veterinary Drug Registration

Registration in china

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Registration process for imported feed, feed additives & veterinary drugs in China.

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Page 1: Registration in china

Date: 28 December 2011

Registration in China

Project: Imported Feed, Feed Additive and Veterinary Drug Registration

Page 2: Registration in china

General Registration Process

Page 3: Registration in china

Key facts

Foreign companies must register their products and obtain the registered

license before selling in china.

The license is valid for 5 years.

The responsible authorities are:

*This process is subject to change

The Ministry of Agriculture (MOA)

China National Feed Quality Control Center

China Institute of Veterinary Drugs Control (CIVDC)

Page 4: Registration in china

Registration diagrams for imported feed, feed additives & veterinary drugs

Dossier preparation

Preliminary review by MOA

Quality test

License approved

Imported Feed Additives (Two Types)

Type 1: On list of approved feed and feed additives

Type 2: Not on list of approved feed and feed additives

Imported Veterinary Drugs

Dossier preparation

Preliminary review by MOA

Quality test

License approved

Clinical trials and residue tests

Evaluation

Dossier preparation

Preliminary review by MOA

Quality test

License approved

Feeding test and safety test

Evaluation

Page 5: Registration in china

Feed and Feed Additives

Type 1

Page 6: Registration in china

Registration for Type 1 products

Preliminary review by MOA

Dossier

preparation

Quality test

License

approved

Registration procedure

TIME

How we help

Months Hours

1. Dossierpreparation

3 300 Organization

2. Preliminary review by MOA

1

50

Connections

3. Quality test 3 Experience

4. License approved 1 Speed

Total 8 350

Note: ①The" Months" is the time the whole registration will take from the beginning to the end. ②The "Hours" is the time I will spend on this registration.

Page 7: Registration in china

The approved feed additives

The approved feed additives are composed of 13 categories of feed additives. They are:

Amino acids (23)Vitamins (32 )Minerals and their complexes(chelates)Enzymes (13)Live Micro-organisms (16)Non-protein nitrogen (9)Antioxidants (4 )Preservatives and Acidity Regulators (30 )Coloring Agents (7)Seasonings and Flavoring Agents (4 feed and other human food additives)Binders, Anti-caking Agents and Stabilizers (32)Polysaccharides and Oligosaccharides (5 )Others (14)

*Note: The list is from No.1126 announcement of MOA.

Page 8: Registration in china

Feed and Feed Additives

Type 2

Page 9: Registration in china

Dossier preparation

Preliminary review by MOA

Quality test

License approved

Feeding test and safety test

Registration for type 2 products

Registrationprocedure

TIMEHow we help

Months Hours

1. Dossier preparation

4 500 Organization

2. Preliminary review by MOA

1

100

Connections

3. Feeding test and Safety test

4 Preparation

4. Evaluation 4

5. Quality test 4 Experience

6. License approved 1 Speed

Total 18 600

①The" Months" is the time the whole registration will take from the beginning to the end.② "Hours" is the time I will spend on this registration.

Evaluation

Page 10: Registration in china

Example of the registered license

Page 11: Registration in china

Veterinary Drugs

Page 12: Registration in china

1. MOA (Ministry of Agriculture):

Issues the registered license for import veterinary

drugs (import and local products)

2. China Institute of Veterinary Drugs Control

(CIVDC)

The Veterinary Drug Evaluation Institute

Quality trial

Responsible authorities

Page 13: Registration in china

Registration procedures

Dossier preparation

Preliminary review by MOA

Quality test

License approved

Clinical trials and residue tests

Evaluation

Registrationprocedures

TIMEHow we help

Months Hours

1. Dossier preparation

4 700 Organization

2. Preliminary review by MOA and CIVDC

6

200

Connections

3. Clinical trials and residue tests

8 Preparation

4. Evaluation by Veterinary Drugs Evaluation Institute

6 Connections

5. Quality test 5 Experience

6. License approved 2 Speed

Total 31 900

NB: ①The" Months" is the time the whole registration will take from the beginning to the end.②The "Hours" is the time I will spend on this registration.

Page 14: Registration in china

Example of the registered license

Page 15: Registration in china

How we can help

Page 16: Registration in china

Barriers for registration

Lack of Experience

• Dedicated team in Beijing office

• We have helped XX companies register products.

• Experienced support for MNC globally

Language

• Based in Beijing, China, AAC registration & support team of 8 trained specialist in Intensive livestock industry.

• Chinese is our team’s 1st language and we are fluent in english

Culture/Connections

• Our china presence and reputation offers leverable opportunities for new entrants.

• Our Team members have Animal Science, Veterinary and Masters qualifications in our industry, we understand the science and the technology

Page 17: Registration in china

Appendix

Page 18: Registration in china

Approved feed additive list (2008)

Page 19: Registration in china

Approved feed additive list (2008)

Page 20: Registration in china

Approved feed additive list (2008)