Drug filing, for supplementary applications, such as changing instructions, packaging materials, raw material origin, production address and many other work that needs to be improved.
Question 2: What does it mean to write the record number on the plaster? It means imported medicine.
Imported drugs need to be filed.
Question 3: What does it mean to register cosmetics with the US Food and Drug Administration? Even after June 30th, 2005, it can be produced and sold. Those that are not filed and have whitening function are illegal sales. Those without whitening function should be filed online, and those without filing can't be sold. To put it bluntly, cosmetic filing is formal, and it is false if it is not filed.
Question 4: What does medical insurance filing mean? It depends on your specific product.
If it is within the scope of filing, you have to go there to declare it first.
Otherwise there is a risk of being investigated.
Question 5: Is the implementation standard, license number and record number written on health care products unique to a certain drug? The implementation standard refers to the classification or nature of commodities, such as medical supplies or nutritional products with health care functions, and the grade of medical supplies. The license number is the proof that the product is qualified and has no toxic and side effects before production is allowed. Without a license number, it is a fake and shoddy product illegally produced. The record number is the number of the record product.
Question 6: How to check the approval number or hygiene license number of drugs? Go to the data query website of the State Administration of Pharmaceutical Products: app1.sfda.gov/datasearch/face 3/dir.
-Click on domestic drugs-Enter the drug name or approval number-Click Query. The results came out. If you look up health care products and choose domestic health food, the rest are the same. If you choose imported drugs and imported health care products, the rest are the same.
Because all medicines and health foods (health products) must be registered by the State Food and Drug Administration and issued with the approval number of medicines and health products before they can be produced or sold on the market, (including imported medicines and health products) all medicines and health products registered by the State Food and Drug Administration and issued with the approval number are filed in the database of the State Pharmaceutical Products Administration and can be searched (health products are approved by the Ministry of Health). What can't be found is fake medicines or fake health products, or food.
Question 7: Did the drug production obtain the approval number after filing? That's for sure.
Question 8: What does the national drug standard number stand for? 1. standard is a unified regulation of repetitive things and concepts within a certain range. It is based on the comprehensive achievements of science, technology and practical experience, and aims at obtaining the best order and promoting the best social benefits. After consultation with relevant parties, with the approval of the competent department, it will be published in a specific form as the criterion and basis of * * * *. The definition (draft) put forward by the International Organization for Standardization (ISO) in the ISO 2 Guide issued in 1986 is: "A document that is unanimously (overwhelmingly) agreed and approved by a recognized standardization body as a measurement standard, rule or characteristic requirement of work or work result, and is repeatedly used by (relevant parties) in order to achieve the best order within a given range." 2. Standardization 1996 The national standard issued by China (GB 3935. 1C96) is defined as the activity of formulating * * * identical and reusable rules for actual or potential problems in order to obtain the best order within a certain range (the above activities mainly include the formulation, publication and implementation process of standards). The definition (draft) put forward by the International Organization for Standardization (ISO) in the ISO 2 Guide issued in 1986 is: "In view of actual or potential problems, the activities carried out to formulate regulations on * * * and reuse (for all parties concerned) are aimed at achieving the best degree of order within a given range." When ISO issued this definition, it made the following two explanations: (1) Especially the activities of formulating, issuing and implementing standards; (2) The important role of standardization is to improve the adaptability of products, production processes and services to predetermined goals and eliminate trade barriers to promote technical cooperation. 3. Standard Grade Standard Grade refers to the classification of standards into national standards, industry standards, local standards and enterprise standards according to the Standardization Law of People's Republic of China (PRC). There is a certain compliance and internal connection between all levels, forming a standard system covering the whole country and with distinct levels. National standards. National standards shall be formulated for technical requirements that need to be unified nationwide. National standards are planned and drafted by the administrative department of standardization of the State Council, and are uniformly examined, approved, numbered and published. The code name of the national standard is GB, which means the combination of the first letters "G" and "B" of the Chinese phonetic alphabet. Industry standard. For technical requirements that need to be unified within a certain industry in the country without national standards, industrial standards can be formulated as a supplement to the national standards, and when the corresponding national standards are implemented, the industrial standards shall be automatically abolished. Industry standards shall be approved, numbered and published by the centralized department of industry standards, and unified management shall be implemented. The centralized department of industry standards and the scope of industry standards managed by it shall be examined and approved by the administrative department of standardization of the State Council, and the industry standard code of this industry shall be published. Local standards. Provinces, autonomous regions and municipalities directly under the Central Government without national and industrial standards may formulate local standards for the following requirements that need to be unified: (1) Safety and health requirements for industrial products; (2) Requirements stipulated by laws and regulations on drugs, veterinary drugs, food hygiene, environmental protection, energy conservation and seeds; (3) Requirements stipulated by other laws and regulations. Local standards shall be uniformly planned, organized, formulated, examined and approved, numbered and promulgated by the standardization administrative departments of provinces, autonomous regions and municipalities directly under the Central Government. Enterprise standards. It is the standard of technical requirements, management requirements and work requirements that need to be coordinated and unified within enterprises. Enterprise standards shall be formulated by the enterprise and approved and promulgated by the legal representative of the enterprise or the competent leader authorized by the legal representative. Enterprise product standards should be filed with * * * within 30 days after release. In addition, in order to meet the needs of the rapid development and changes of standards in some fields, a "national standardization guiding technical document" is added to the four-level standard stipulated in 1998 as a supplement to the national standard, and its code name is "GB/Z". For projects that meet one of the following conditions, guiding technical documents can be formulated: (1) projects whose technology is still developing and need corresponding documents to guide their development or have standardization value and cannot be formulated as standards; (2) Projects adopting technical reports from international organizations (including regional international organizations) such as the International Organization for Standardization and the International Electrotechnical Commission. Guiding technical documents are for users' reference only. 4. Standard Attributes According to the provisions of the Standardization Law of People's Republic of China (PRC), national standards and industry standards can be divided into mandatory standards and recommended standards. Standards for safeguarding human health and personal and property safety and mandatory provisions of laws and administrative regulations ... >>
Question 9: Who knows how to check whether food and medicine are on record? All drugs must be registered and approved by the State Administration of Pharmaceutical Products before they can be produced and sold, and all health products must be approved by the State Administration of Pharmaceutical Products or the Ministry of Health before they can be produced and sold. All approved drugs and health care products have approval numbers, which are recorded in the database of the State Administration of Medical Products. You can find detailed information in this database. What can't be found is fake drugs and fake health care products.
In addition, there is no record of food approved by the province in the database of the State Administration of Pharmaceutical Products, so what you can't find may be food. However, according to state regulations, pharmacies may not sell food as health care products.
Is it medicine? Is it western medicine or Chinese medicine? Is it a health product or a food? Is it true, bad or fake? You can see it clearly from the outer packaging.
The simplest and most accurate identification method is to look at the approval number on the package. 1. The approval number must be seen on the drug packaging: "National Medicine Standard H (or Z.S.J.B)+)+Year Number+Serial Number", which means the drugs approved for production and marketing by the State Administration of Pharmaceutical Products, the letter H stands for chemical drugs, Z stands for proprietary Chinese medicines, S stands for biological products, J stands for imported drugs, and B stands for health care drugs. 2. If there is no "National Medicine Zhunzi" on the package, it must be fake medicine, or there is "National Medicine Zhunzi". You can log in to the database of the State Pharmaceutical Products Administration and enter the "National Medicine Zhunzi", year number and serial number. What can't be found is also fake medicine. If the expiration date is not marked or changed on the packaging of drugs, if the production batch number is not marked or changed, all drugs that exceed the expiration date are inferior drugs. In this case, you should report to the local food and drug administration and ask for compensation.
The simple identification method of health food (health care products) and food is that the approval number of health care products or food can be seen on the package. 1. The approval number of the State Pharmaceutical Products Administration or the approval number of the Ministry of Health must be seen on the package of health products: Wei Shi Jian Zi (Wei Shi Jin Jian Zi). The letter G at the back means domestic J means imported. It is also stipulated that the package or label must be marked with a special logo for health care products: "police mobile unit", which is similar to the pattern of police mobile unit and marked with the words "health food" below. Without the police, the mobile units are all fake health products. 2. The food is marked with "food production license number" on the package, and the number begins with QS, followed by the serial number. There is a kind of "health permit number", which starts with the abbreviation of each province, followed by a serial number, such as Yu Wei Food Certificate, Yue Wei Food Certificate and Huwei Food Certificate. Its logo is a deformed blue Q with a white S on a rectangular white background. There are four words under the logo of QS: quality and safety. In short, buying drugs must depend on whether there is an approval number: "National Medicine Zhunzi". If you have any questions about the quasi-word of Chinese medicine, you can log in to the database of the State Pharmaceutical Administration. If you can't find it, it's fake. Buying health care products depends on: is there an approval number from the police, mobile units and the state? You can also log in to the database of the State Administration of Medical Products. What you can't find is fake health care products. When you buy food, you should look for QS logo and food production license number. Even your soy sauce label has the QS logo.
Question 10: What is the difference between the approval number of drug registration and trademark registration? The drug registration approval document is a legal document issued by the State Administration of Pharmaceutical Products to pharmaceutical production enterprises to produce this variety. In layman's terms, it is the "birth certificate" of this drug, which is commonly called "production approval". For the same drug, if the policy allows, many pharmaceutical companies may apply for registration, and after passing the national review, many pharmaceutical companies will approve the production. Therefore, every pharmaceutical factory will have a "drug registration approval" for drugs, but the "approval number" is different. Enterprises can start production when they get this approval.
Trademarks are issued by the Trademark Office, which is a sign to distinguish the sources of goods and services. Take drugs as an example. A drug production license may be granted to many enterprises. In order to distinguish themselves, different enterprises will also apply for corresponding trademarks for their products to show the difference. When an enterprise obtains the drug registration approval document, it is equivalent to obtaining the production license. However, if the trademark is not obtained, the drugs produced cannot enter the market. This is a general difference between the two.
In order to standardize the operation order of the market and create a more healthy and stable market environment, the state has set up many audits. Relevant employees must apply for the licenses required for production and operation in accordance with regulations, and participate in market competition fairly and reasonably.