Is it legal for the folk circulation of plasters made by ancestral secret recipes?

In fact, as long as the procedures are complete, pass the national inspection, go through the formal procedures, and the effect is particularly good, solve the pain for people, and bring happiness into thousands of households, this is legal, but if it is a small workshop without any formalities to produce, it is illegal...

Legal analysis: There are two ways to legalize homemade plasters: 1. Apply for a patent; 2. Find a way to sell the patent to the big pharmaceutical company, and you can ask for a share of the profit when signing the contract.

The state has set up administrative licenses for the production and sale of drugs, and failure to obtain the corresponding qualifications and licenses in accordance with legal procedures is a minor administrative violation and a serious crime. Only manufacturers with legal qualifications can guarantee the smooth flow of goods. In this way, the qualification plaster can be safe and legal.

Legal basis: Article 7 of the "Good Manufacturing Practice for Pharmaceutical Operations" The quality management department shall perform the following duties: (1) supervise and urge relevant departments and post personnel to implement the laws and regulations on drug management and this specification; (2) Organize the formulation of quality management system documents, and guide and supervise the implementation of documents; (3) Responsible for reviewing the legitimacy of the supplier and the purchasing unit, the legality of the purchased drugs, and the legal qualifications of the sales personnel of the supplier and the purchasing unit, and dynamically managing them according to the changes in the audit content; (4) Responsible for the collection and management of quality information, and the establishment of drug quality files; (5) Responsible for the acceptance of drugs, guide and supervise the quality management of drug procurement, storage, maintenance, sales, returns, transportation and other links; (6) Responsible for the confirmation of substandard drugs and supervise the processing process of substandard drugs; (7) Responsible for the investigation, handling and reporting of drug quality complaints and quality accidents; (8) Responsible for the reporting of counterfeit and inferior drugs; (9) Responsible for drug quality inquiry; (10) Responsible for guiding and setting up computer system quality control functions; (11) Responsible for the review of computer system operation authority and the establishment and update of basic data for quality management; (12) Organize verification and calibration of relevant facilities and equipment; (13) Responsible for the management of drug recalls; (14) Responsible for the reporting of adverse drug reactions; (15) Organize internal audit and risk assessment of the quality management system; (16) Organize the inspection and evaluation of the quality management system and service quality of drug suppliers and purchasers; (17) Organize the review of the transportation conditions and quality assurance capabilities of the carrier entrusted for transportation; (18) Assist in quality management education and training; (19) Other duties that should be performed by the quality management department.

You need to make two applications, one is to apply for the "Medical Institution Preparation License"; The second is to apply for the registration of preparation products. If you are a natural person and want to produce such drugs, you can start a drug manufacturing enterprise and carry out the production of drugs, you must first obtain the "Drug Manufacturing Enterprise License", and then register the product to obtain the "Drug Registration Certificate".

Legal basis: Article 30 of the Drug Administration Law of the People's Republic of China refers to the enterprise or drug development institution that has obtained the drug registration certificate. The marketing authorization holder shall, in accordance with the provisions of this Honorable Dispensing Law, assume responsibility for the non-clinical research, clinical trials, production and operation, post-marketing research, adverse reaction monitoring, reporting and treatment of the drug.

Other units and individuals engaged in the development, production, operation, storage, transportation, use and other activities of the first product of the medicine bend shall bear corresponding responsibilities in accordance with the law. The legal representative and main person in charge of the marketing authorization holder of the drug are fully responsible for the quality of the drug.

There are two ways to legalize a homemade plaster: 1. Apply for a patent; 2. Find a way to sell the patent to the big pharmaceutical company, and you can ask for a share of the profit when signing the contract. The state has set up administrative licenses for the production and sale of Lingpants Zheng drugs, and has not obtained the corresponding qualifications and licenses in accordance with legal procedures, which is a minor administrative violation and a serious crime.

Only manufacturers with legal qualifications can guarantee the smooth flow of goods. In this way, the qualification plaster can be safe and legal. Legal basis:

Article 7 of the "Good Practice for Drug Operation" The quality management department shall perform the following duties: (1) supervise and urge relevant departments and post personnel to implement the laws and regulations on drug management and this specification; (2) Organize the formulation of quality ruler management system documents, and guide and supervise the implementation of documents; (3) Responsible for reviewing the legitimacy of the supplier and the purchasing unit, the legality of the purchased drugs, and the legal qualifications of the sales personnel of the supplier and the purchasing unit, and dynamically managing them according to the changes in the audit content; (4) Responsible for the collection and management of quality information, and the establishment of drug quality files; (5) Responsible for the acceptance of drugs, guide and supervise the quality management of drug procurement, storage, maintenance, sales, returns, transportation and other links; (6) Responsible for the confirmation of substandard drugs and supervise the processing process of substandard drugs; (7) Responsible for the investigation, handling and reporting of drug quality complaints and quality accidents; (8) Responsible for the reporting of counterfeit and inferior drugs; (9) Responsible for drug quality inquiry; (10) Responsible for guiding the setting of the computer system's quality and local control functions; (11) Responsible for the review of computer system operation authority and the establishment and update of basic data for quality management; (12) Organize verification and calibration of relevant facilities and equipment; (13) Responsible for the management of drug recalls; (14) Responsible for the reporting of adverse drug reactions; (15) Organize internal audit and risk assessment of the quality management system; (16) Organize the inspection and evaluation of the quality management system and service quality of drug suppliers and purchasers; (17) Organize the review of the transportation conditions and quality assurance capabilities of the carrier entrusted for transportation; (18) Assist in quality management education and training; (19) Other duties that should be performed by the quality management department.

It is illegal to sell ancestral black plaster without obtaining the relevant permission. Only those who have obtained the relevant drug production and operation license can be sold. The marketing authorization holder of a drug may sell the drugs for which it has obtained a drug registration certificate on its own, or may entrust a drug business enterprise to sell them.

If a marketing authorization holder engages in drug retail activities, it shall obtain a drug business license.

If the marketing authorization holder sells the drug on its own, it shall meet the conditions specified in Article 52 of this Law; If the sales are entrusted, the qualified drug business enterprises shall be entrusted. The marketing authorization holder and the entrusted business enterprise shall sign an entrustment agreement and strictly perform the obligations agreed in the agreement. If an individual who sells plasters has pharmacist qualifications; Have the appropriate business premises, equipment, storage facilities and hygienic environment; There is a quality management organization or personnel; After the approval of the drug regulatory department, it is not illegal to sell ointment.

According to the law, the following conditions must be met to start a pharmaceutical business enterprise:

1. Have qualified pharmaceutical technicians in accordance with the law.

2. Have a business premises, equipment, storage facilities and sanitary environment suitable for the drugs operated.

3. Have a quality management organization or personnel suitable for the drugs handled.

4. Rules and regulations for the quality of pharmaceutical products.

Article 14 of the Drug Administration Law stipulates that the establishment of a drug wholesale enterprise shall meet the requirements of the reasonable layout of drug wholesale enterprises in provinces, autonomous regions and municipalities directly under the Central Government, and meet the following setting standards:

1) Have rules and regulations for the quality of the drugs handled;

2) The enterprise, the legal representative of the enterprise, the person in charge of the enterprise, or the person in charge of quality management do not have the circumstances specified in Articles 75 and 82 of the Drug Administration Law;

3) Have a certain number of licensed pharmacists suitable for the scale of operation. The person in charge of quality management must have a university degree or above and must be a licensed pharmacist;

4) It has a room temperature storage, cool storage and cold storage that can ensure the quality requirements of drug storage and adapt to its business varieties and scales. The warehouse has special shelves suitable for drug storage and devices and equipment to realize the modern logistics system of drug storage, transmission, sorting, shelving and delivery;

Legal basis:

Drug Administration Law of the People's Republic of China

Article 51.

To engage in drug wholesale activities, it shall be approved by the people's drug regulatory department of the province, autonomous region or municipality directly under the Central Government to obtain a drug business license. To engage in drug retail activities, it shall be approved by the local people's drug regulatory department at or above the county level where it is located, and obtain a drug business license. Without a drug business license, no drug shall be dealt.

The drug business license shall indicate the validity period and business scope, and shall be re-examined and issued upon expiration. In addition to the conditions stipulated in Article 52 of this Law, the drug regulatory department shall also follow the principle of facilitating the purchase of drugs by the masses in the implementation of drug business licenses.