About the use of pharmaceutical additives and interpretation of
Special note
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First, according to the Ministry of Agriculture of the People's Republic of China Announcement No. 2438 and the Ministry of Agriculture of the People's Republic of China Announcement No. 2513, special interpretation is as follows:
1. All veterinary drugs contained in the veterinary 2015 edition and the veterinary drug quality standard 2017 edition shall be executed according to these two documents, and all other documents shall be invalidated;
2, veterinary drugs that have been ordered to be banned from use;
3. If it is not included in the above two documents and has not been ordered to be prohibited, it shall be executed according to the previous documents.
Second, for the pharmaceutical additives used in feed, can be analyzed as follows:
168 announced drug varieties (except coccidiosis drugs) as follows:
Bacitracin zinc, flavomycin, oregano oil, oxytetracycline calcium, chlortetracycline (feed grade), enramycin, ammonia arsenate (arsenic acid), rosacea, monensin, vitamin 17 kinds of genomicin, olaquindox, nosiheptide, aramipamicin, salinomycin, colistin sulfate, bacitracin zinc, colistin sulfate, and guitarmycin.
1, which is included in the "Veterinary Pharmacopoeia 2015 Edition", according to the "Veterinary Pharmacopoeia 2015 Edition", the product standard listed in the 168 announcement is invalid: bacitracin zinc, salinomycin sodium and , etc., of which:
A, bacitracin zinc standard is the same as 168 announcement, usage and dosage can not be adjusted;
B, salinomycin sodium is adjusted to be used only for coccidiosis, and can not be used for cattle and pigs;
C, the maximum limit of the guitarmycin pig is adjusted to 50ppm (168 announced as 55ppm).
2, not included in the "Veterinary Pharmacopoeia 2015 Edition", but included in the "Veterinary Drug Quality Standard 2017 Edition", according to the "Veterinary Drug Quality Standard 2017 Edition", the 168 announcement listed product standards are invalid:
Nine arsenic acid (arsenic acid), rosacea, olaquindox, quinocetone, flavomycin, oxytetracycline calcium, chlortetracycline, nosiheptide, colistin sulfate premix. Of which:
A, the same as the No. 168 announcement: ammonia arsenic acid (arsenic acid), rosacea, olaquindox, usage and dosage can be adjusted;
B, quinocetone is not included in the 168 announcement, can be used for pigs before 35kg, the same amount of olaquindox;
C, the dosage limit is unchanged, but the increase of the standard is: chlortetracycline increased 20% content standard, flavomycin increased 12% and 20% content standard;
D, usage and dosage changes: oxytetracycline calcium is announced according to No. 2328, the maximum limit is 400ppm. Nosihide is announced in 1960: expand the use of the range to pigs and increase the product content standard.
E. Colistin sulfate premix should not be added as growth promotion from May 1, 2017.
3, not included in the "Veterinary Pharmacopoeia 2015 Edition" and "Veterinary Drug Quality Standard 2017 Edition", according to the original 168 announcement standards are: monensin, enramycin, virginiamycin, amiramycin 5 oregano oil.
4. Not included in the veterinary pharmacopoeia 2015 edition and the veterinary drug quality standard 2017 edition, but it has been ordered to be banned as a growth-promoting additive: colistin sulfate + bacitracin zinc premix.
Please refer to Appendix 1 for the inclusion and changes of veterinary drug varieties:
Appendix 1, Announcement Class 1 Antibiotics VS Veterinary Pharmacopoeia and Veterinary Drug Quality Standards
Appendix 2, Ministry of Agriculture of the People's Republic of China Announcement No. 2438
Appendix 3, Ministry of Agriculture of the People's Republic of China Announcement No. 2513
References:
1, the Ministry of Agriculture of the People's Republic of China Announcement No. 168
2, the Ministry of Agriculture of the People's Republic of China Announcement No. 2438
3, "People's Republic of China Pharmacopoeia" (2015 edition)
4, the Ministry of Agriculture of the People's Republic of China Announcement No. 2513
5, "Veterinary Drug Quality Standards" (2017 version) directory and designated Ministry of Agriculture announcement
6, the Ministry of Agriculture of the People's Republic of China Announcement No. 1960
7, "National Standards for Veterinary Drugs" (2013 Edition)
Appendix 1, Announcement Class 1 Antibiotics VS Veterinary Pharmacopoeia and Veterinary Drug Quality Standards
Remarks:
1. The veterinary drug quality standard (2017 version) is not a new standard. It is a re-sale of the previous Ministry of Agriculture announcement and the National Standard for Veterinary Drugs (2013 Edition). The main announcements include 1960, 1506, 2328, 1759, 1435 and so on.
2. According to the Ministry of Agriculture 2824 announcement, colistin sulfate is banned for growth promotion after April 30, 2017;
3, nicarbazin, nicarbazin + ethoxy amide benzyl ester, enramycin and other imported veterinary drug standards, after the expiration of the number of domestic no longer approved;
4. Please pay attention to the changes of some pharmaceutical additives: 50% olaquindox premix will not be approved after the expiration date; the guitarmycin limit is adjusted to 50ppm; salinomycin sodium can only be used for poultry.
Appendix 2, Ministry of Agriculture of the People's Republic of China Announcement No. 2438
Date: 2016-08-23 00:00 Issued by: Ministry of Agriculture, Veterinary Bureau Source:
According to the Regulations on the Administration of Veterinary Drugs, our ministry has completed the preparation of the First, Second and Third Parts of the "Veterinary Pharmacopoeia of the People's Republic of China (2015 Edition)" (hereinafter referred to as "Chinese Veterinary Pharmacopoeia (2015 Edition)". It will be implemented as of November 15, 2016. The relevant matters are announced as follows.
1. The Chinese Veterinary Pharmacopoeia (2015 Edition) is a statutory technical standard that should be followed in the development, production (import), operation, use and supervision of veterinary drugs.
2. The Chinese Veterinary Pharmacopoeia (2015 Edition) includes all cases, texts and appendices. From the date of the implementation of the Chinese Veterinary Pharmacopoeia (2015 Edition), the original veterinary pharmacopoeia, the national standards for veterinary drugs (chemical drugs, Chinese medicine volumes, the first volume) and the Ministry of Agriculture announcements, etc. At the same time abolish.
3. The "Chinese Veterinary Pharmacopoeia (2015 Edition)" contains the specifications of the preparations that have not been included in the variety (except for the abolished). The quality standards are carried out in accordance with the relevant requirements of the Chinese Veterinary Pharmacopoeia (2015 Edition). The approval document is executed.
4. The following standards will continue to be valid, but the general requirements of the Chinese Veterinary Pharmacopoeia (2015 Edition) should be implemented.
(1) The National Veterinary Pharmacopoeia (2015 Edition) does not contain varieties and has not published the abolished national standards for veterinary drugs;
(2) The national standard for veterinary drugs not approved by the Chinese Veterinary Pharmacopoeia (2015 Edition).
5. Enterprises and veterinary drug inspection agencies that declare the approval number of veterinary drug products from November 15, 2016 shall conduct sample inspection in accordance with the requirements of the Chinese Veterinary Pharmacopoeia (2015 Edition) and mark the Chinese Veterinary Pharmacopoeia (2015) on the veterinary drug inspection report. Year edition) "Veterinary drug quality standards. Previously declared, the implementation standard marked by the veterinary drug inspection report may be the original veterinary drug quality standard, or may be marked with the "Chinese Veterinary Pharmacopoeia (2015 edition)" veterinary drug quality standard.
6. The corresponding veterinary drug products produced before November 15, 2016 (inclusive) may be inspected according to the original veterinary drug standards and used for circulation during the product validity period.
7. Veterinary management departments at all levels should actively carry out the promotion, implementation and implementation of the Chinese Veterinary Pharmacopoeia (2015 Edition), and collect and feedback relevant questions and opinions in a timely manner. The Chinese Veterinary Pharmacopoeia Committee should promptly respond to relevant issues reflected by various places and do a good job in technical guidance.
8. Veterinary drug companies should conscientiously implement the "Chinese Veterinary Pharmacopoeia (2015 Edition)" to continuously improve the quality control level of veterinary drug products.
Special announcement.
　 Appendix 3, Ministry of Agriculture of the People's Republic of China Announcement No. 2513
Date: 2017-04-14 00:00 Issued by: Ministry of Agriculture, Veterinary Bureau Source:
In order to strengthen the management of national standards for veterinary drugs, the Ministry of Health has revised the quality standards for veterinary drugs that were released before December 31, 2010 and not included in the Chinese Veterinary Pharmacopoeia (2015 edition), and compiled into the "Veterinary Drug Quality Standards" (2017 edition). And has developed a supporting model specification, which is hereby released and will be implemented as of November 1, 2017. The relevant matters are hereby announced as follows.
First, the "Veterinary Drug Quality Standards" (2017 edition) includes three parts: chemical medicine rolls, Chinese medicine rolls and biological products rolls.
2. From November 1, 2017, except for the Chinese Veterinary Pharmacopoeia (2015 edition) and the Veterinary Drug Quality Standard (2017 edition) containing the quality standards for veterinary drugs, before December 31, 2010 (including 31 days) ) The editions of "Chinese Veterinary Pharmacopoeia", "National Standards for Veterinary Drugs", "Quality Standards for Veterinary Biological Products", "Procedures for Biological Products for Veterinary Products" and the quality standards for veterinary drugs issued by the Ministry of Agriculture are also abolished at the same time.
The specifications of the preparations that have not been included under the variety of veterinary drug quality standards (2017 edition) (except for those that have been revoked) shall be subject to the relevant requirements of the veterinary drug quality standard (2017 edition) and the specifications. The approval document is executed.
3. Since November 1, 2017, if the “Veterinary Drug Quality Standard†(2017 edition) is included in the veterinary drug product approval document number, the enterprise and veterinary drug inspection agency shall carry out the sample according to the “Veterinary Drug Quality Standard†(2017 edition). Inspection, the inspection basis on the veterinary drug inspection report shall be "Veterinary Drug Quality Standard" (2017 edition); the product label and instructions shall be prepared in accordance with the specification of the specification manual of the "Veterinary Drug Quality Standard" (2017 edition), and the label content shall not exceed the contents of the specification. range.
4. Before October 31, 2017 (including 31st), the “Veterinary Drug Quality Standard†(2017 edition) will be submitted with the approval number of the veterinary drug product. The veterinary drug inspection standard may be the quality standard of the original veterinary drug, or the quality of the veterinary drug. Standards (2017 edition); product labels and instructions can be prepared in accordance with the original regulations, or in accordance with the contents of the specification manual of the Veterinary Drug Quality Standard (2017 edition). The label content must not exceed the scope of the specification.
5. The veterinary drug products produced before October 31, 2017 can be inspected according to the quality standards of the original veterinary drugs.
6. If the veterinary drug label and the contents of the instructions do not meet the requirements of the model, the veterinary drug label and the contents of the instructions do not meet the requirements of the model before the November 1st, 2017. The veterinary drug manufacturer shall modify it according to the contents of the model and print it. New labels and instructions, original labels and instructions can continue to be used until June 30, 2018. Veterinary products manufactured using the original label and instructions before June 30, 2018, can be circulated during the life of the product.
7. The specifications of the veterinary drug products that have been abolished, and the corresponding product approval number obtained by the veterinary drug manufacturer shall be cancelled at the same time as the implementation of the "Veterinary Drug Quality Standard" (2017 edition). Where the general name of a veterinary drug product is changed, the approval procedure for the approval of the batch shall be performed in accordance with the relevant provisions of the Ministry of Agriculture Announcement No. 2481.
8. For the application of the "Veterinary Drug Quality Standard" (2017 version) before November 1, 2017, the product approval number and the veterinary drug inspection report execution standard are the original standards. When the application is returned again, the original inspection report is in 2018. Continue to use until the 31st of the month.
IX. The acceptance of interpretation and feedback on the Quality Standard for Veterinary Drugs (2017 Edition) is the responsibility of the Office of the Chinese Veterinary Pharmacopoeia Commission.
X. The specific content of the model specification can be queried in the “Veterinary Drug Label Information†in the “National Veterinary Drug Basic Information Inquiry System†of the Chinese Veterinary Drug Information Network.
Hereby announce the
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