How to write the product instructions for veterinary drug approval applications

For national standard generic drugs, refer to the "Guidelines for the Use of Veterinary Drugs", and for new drugs, they should be prepared in accordance with the instructions and label management regulations.

First, about the label instructions.

1) According to the actual situation of the document number work and the needs of informatization work, the content of the label specification will not be modified in the technical review process, and if the content of the label specification is inconsistent with the provisions (including typos), the review opinion that does not meet the requirements will be given on the grounds that "the label specification is written incorrectly".

2) In accordance with the 2010 edition of the Veterinary Pharmacopoeia of the People's Republic of China, in view of the announcement No. 1592 of the Ministry of Agriculture, "the 2010 edition of the Guidelines for the Use of Veterinary Drugs in addition to indications, usage and dosage, specifications, other items can be used as the basis for the approval of veterinary drug labels and instructions". The indications, usage, dosage, and specifications in the content of the label instructions are temporarily referred to the 2005 edition of the "Guidelines for the Use of Veterinary Drugs".

3) For those declared in accordance with the national standards for veterinary drugs other than the veterinary pharmacopoeia, if the national standards for veterinary drugs are published with a model instruction manual, it should be prepared according to the template instructions, and in principle, it is not allowed to modify any content except for enterprise information.

4) When the declaration number, the instructions are mainly prepared based on the applied implementation standards (mainly based on the implemented standards), and there are no items on the standard but the "Measures for the Administration of Veterinary Drug Labeling and Instructions" stipulate that there must be items on the instructions, such as adverse reactions, pharmacological effects, withdrawal periods, etc., you can refer to the latest version of the "Guidelines for the Use of Veterinary Drugs" and Announcement No. 278 of the Ministry of Agriculture.

5) According to the "Measures for the Administration of Veterinary Drug Labels and Instructions" (Order No. 22 of the Ministry of Agriculture), the ratio of generic names to commodity names shall not be less than 1:2 (referring to the area), that is, the area occupied by the trade name shall not be 1 times or more of the area of the generic name, and the instructions prepared by some application materials ignore this requirement. The instructions prepared by some enterprises are not prepared in strict accordance with the implemented standards, but without authorization, they have increased indications, exaggerated the efficacy or expanded the applicable animals, etc., and some labels and instructions are printed with animal patterns that have nothing to do with the animals applicable to veterinary drugs.

In the case of the above-mentioned circumstances, a review opinion that does not meet the requirements will also be given on the grounds that "the label manual is incorrectly prepared".

6) When compiling the manual, the usage and dosage of some of the products with increased specifications and "based on this product" need to be converted. Taking erythromycin thiocyanate soluble powder as an example, the original specification and dosage are 100g 5g (5 million units), calculated according to this product, mixed drink per 1L water chicken for 3 5 days; Announcement No. 596 of the Ministry of Agriculture added 100g million units), and its active ingredient content decreased from 5% to when declaring this new specification product, the dosage should be converted. For new specifications but the dosage is based on "active ingredient", no conversion is required.

7) For the quality standards that increase the specifications through the change of registration, according to the opinions of the management department, temporarily in accordance with the principle of who changes and who uses, non-change units cannot use the standard declaration number. (Special attention should be paid to this provision, is it appropriate?) ）

Veterinary drug approval number and batch number are not the same concept.

1) The veterinary drug product approval number is a veterinary drug approval certificate issued by the Ministry of Agriculture when it approves a specific veterinary drug manufacturer to produce specific veterinary drug products in accordance with the national standards, production process and production conditions of veterinary drugs.

The format of the approval number of veterinary drug products is: abbreviation of veterinary drug category, year number, serial number of the province (autonomous region, municipality directly under the central government) where the enterprise is located, serial number of the enterprise, and number of veterinary drug species.

The format is as follows: Abbreviation for the category of veterinary drugs. The category of pharmaceutical additives is abbreviated as "veterinary drug additives"; The categories of serum products, vaccines, diagnostic products, microecological products, etc. are referred to as "veterinary drugs"; The categories of Chinese herbal medicines, Chinese patent medicines, chemicals, antibiotics, biochemical drugs, radioactive drugs, external pesticides and disinfectants are referred to as "veterinary drugs".

The year number is indicated by four digits, i.e. the year in which the product approval number was issued.

The serial number of the province where the enterprise is located is indicated by 2-digit Arabic numerals, which is prescribed and announced by the Ministry of Agriculture.

The serial number of the enterprise is sorted by province, represented by 3-digit Arabic numerals, and announced by the Ministry of Agriculture.

The number of veterinary drugs is indicated by 4-digit Arabic numerals, which is prescribed and announced by the Ministry of Agriculture.

2) The batch number of veterinary drug production is the number of a certain number of veterinary drug products produced by veterinary drug manufacturers with the same nature and quality within the specified period of time and in the same continuous production cycle. Generally, 6 8 digits are used, the first two or four digits represent the year, the middle two digits represent the month, and the last two digits indicate the day. There are also some veterinary drug manufacturers who use their own unique production batch number compilation method to express.

The general production batch number format is as follows:

For example, a veterinary drug manufacturer produced a batch of gentamicin sulfate injection on August 28, 2008, then the production batch number of the batch of veterinary drugs can be set as: 20080828 according to the production batch number of the veterinary drug, the production quality of the batch of veterinary drugs can be traced, and it is conducive to grasping the storage period of the batch of veterinary drugs.

The veterinary drug approval number refers to the Xu Lianxiang certificate that needs to be obtained before the production and sale of veterinary drug products, which is used to ensure the quality and safety of veterinary drugs. To apply for a veterinary drug approval number, you generally need to follow the steps below:

Application for registration of veterinary drugs**.

Technical data of veterinary drugs, including ingredients, uses, preparation processes, quality standards, indications and other information of veterinary drugs.

Scientific research reports on the efficacy and toxicology of animal air attack drugs.

Veterinary drug production process and quality control scheme.

results of clinical trials of veterinary drugs, etc.

2.Consult with relevant authorities: Consult with veterinary drug regulatory authorities or relevant departments according to the regulatory and policy requirements of your country or region for specific application procedures, review requirements, fees and other information.

3.Fill in the application**: According to the requirements, fill in the application form on the designated application** and attach the corresponding application materials.

5.Review and evaluation: The applicant will review and evaluate the application materials, including the quality, safety, and effectiveness of veterinary drugs.

6.Approval and issuance number: If the application meets the requirements, the approval authority will approve and issue a veterinary drug approval number after passing the review. Fees may apply.

Please note that the specific application process and requirements vary from country to country. It is recommended that you consult with your local veterinary drug regulatory authority or relevant authorities in detail before starting your application to ensure that the application for a veterinary drug approval number is completed in accordance with the prescribed procedures. In addition, in order to ensure the quality and safety of veterinary drugs, it is also necessary to comply with relevant regulations and standards, and conduct necessary clinical trials and safety assessments.

The application steps for the veterinary drug approval number are as follows:

1.The applicant submits the application to the Ministry of Agriculture with the application materials and shall submit the following information:

Application Form for Approval Number of Veterinary Drug Products" in duplicate.

Veterinary Drug Production License" in duplicate

Veterinary drug GMP certificate" in duplicate.

New Veterinary Drug Registration Certificate" in duplicate.

A copy of the review inspection report shall be in duplicate.

Samples of labels and instructions are in duplicate.

The production process, formula and other information of the product are in duplicate.

2.The Ministry of Agriculture shall send the application materials to the China Veterinary Drug Supervision Institute for expert review within 5 working days from the date of acceptance, and make an approval decision within 15 working days from the date of receipt of the review opinion.

3.If it is destroyed in accordance with the regulations, the approval number, approval label and instruction manual of the veterinary drug product shall be issued.

Through the above steps, you can complete the application for the veterinary drug approval number.