According to the State Drug Administration Order No. 23, to further strengthen and standardize the packaging of medicines, labeling management, to ensure that
"Pharmaceutical Packaging, Labeling and Instruction Manuals Management Regulations" (Interim) of the implementation of the rules, especially the development of the rules.
General Requirements
One, the drug packaging, labeling must be in accordance with the requirements of the State Drug Administration printing, its text and graphics shall not be added to any unapproved content. Drug packaging is divided into inner packaging and outer packaging. Drug packaging, labeling content shall not exceed the State Drug Administration approved the drug specification limited content.
Two, pharmaceutical packaging, labeling printed on the content of the product should be accurate, in addition to the expression of safety, rational use of medication words, shall not be printed with a variety of inappropriate publicity product text and logos, such as "national new drugs", "protected varieties of Chinese medicine ", "GMP certification", "imported raw materials," "supervised production", "honorary products ", "award-winning products", "quality insurance from insurance companies", "reimbursement of public expenses", "modern technology ", "precious herbs" and so on.
Three, the trade name of the drug must be approved by the State Drug Administration before the packaging, labeling. Trade names shall not be hyphenated with the generic name, should be divided into lines. Trade names by the trademark registration, must still comply with the principle of trade name management. The ratio of generic name and trade name words shall not be less than 1:2 (referring to the area). Generic name font size should be consistent, without brackets. Without the approval of the State Drug Administration as a trade name used as a registered trademark, can be printed in the upper left corner of the package label or the upper right corner of the font shall not be larger than the generic name of the word.
Four, the same enterprise, the same drug of the same specification varieties (refers to the drug specifications and packaging specifications of the two), its packaging, labeling format and color must be consistent, and shall not use different trademarks. The same enterprise of the same variety of different specifications, if any, the smallest sales unit of packaging, labeling should be clearly different or specifications should be clearly marked.
Fifth, the minimum sales unit of drugs, refers to the minimum packaging directly for the listed drugs. Each minimum sales unit of packaging must be printed in accordance with the provisions of the label and instructions.
VI, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and other special management of drugs, medicines for external use, non-prescription drugs in their packaging, packaging, minimum sales unit and labeling must be printed in accordance with the provisions of the logo; on the storage of medicines with special requirements, must be in the packaging, labeling, in a conspicuous position.
VII, imported drugs packaging, labeling in addition to the implementation of these rules, should also indicate "imported drug registration certificate number"
or "pharmaceutical product registration certificate number", the name of the manufacturer; imported sub-packaged drugs packaging, Labeling should be marked with the original country or region of production enterprise name, production date, batch number, expiration date and the name of the domestic sub-packaging enterprises.
VIII, approved by the off-site production of drugs, its packaging, labeling should also indicate the name of the group, producer, production site; approved commissioned the processing of drugs, its packaging, labeling should also indicate the commissioning of the two sides of the name of the enterprise, the processing site.
Nine, where the sale and use of drugs in China, packaging, labeling text must be based on the Chinese language and the use of the State Language and Literature Commission announced the current standard text. Ethnic drugs can increase their ethnic characters. Enterprises according to need, in its drug packaging can use bar codes and foreign language control; China's patented products, can also mark the patent mark and patent number, and indicate the type of patent license.
Ten, the expression of the expiration date of the packaging label, in chronological order. The general expression of the validity of a particular year to a particular month, or only with the figures. Such as valid until October 2001, or expressed as valid until 2001.10, 2001/10, 2001-10 and other forms. Year to be expressed in four digits, 1 to 9 months before the number of digits must be added to two digits to indicate the month.
Various types of pharmaceutical packaging, labeling content
A, chemical drugs and biological products, preparations:
(a) the inner packaging labeling content includes:
Drug name, specifications, indications, dosage, storage and production date, production batch number, expiration date and production companies. Due to the size of the package and can not be fully labeled with the above content, can be appropriately reduced, but at least three must be labeled with the name of the drug, specifications, production batch number (such as ampoules, eye drops bottle, injection bottle, etc.).
(ii) direct contact with the inner packaging of the outer packaging labeling content includes:
Drug name, ingredients, specifications, indications, dosage, storage,
Adverse reactions, contraindications, precautions, packaging, date of manufacture, production batch number, expiration date, approval number and manufacturing enterprises. Due to the size of the package and can not indicate adverse reactions, contraindications, precautions, should be indicated "see instructions".
The prophylactic biological products, the above indications should be listed as the target of vaccination.
(C) large package labeling content includes:
Drug name, specifications, production lot number, date of production, expiration date, storage, packaging, approval number, manufacturer and transportation precautions or other markings.
Second, API labeling content includes:
Drug name, packaging specifications, production lot number, date of production, expiration date, storage, approval number, manufacturer and transportation precautions or other markings.
Three, Chinese medicinal preparations:
(a) the contents of the inner packaging label includes:
drug name, specifications, function and main treatment, dosage, storage, date of manufacture, production batch number, expiration date, and the production company. Due to label size limitations can not indicate all of the above, can be appropriately reduced, but at least three must be labeled with the name of the drug, specifications, production batch number, such as ampoules, injection bottles and so on. Chinese medicine pills wax shell must be labeled at least the name of the drug.
(ii) direct contact with the inner packaging of the outer packaging labeling content includes:
Drug name, ingredients, specifications, function and main treatment, dosage, storage, adverse reactions, contraindications, precautions, packaging, date of manufacture, production batch number, expiration date, approval number and manufacturing enterprises. Due to the size of the package and can not indicate adverse reactions, contraindications, precautions, should be indicated "see instructions".
(C) large package labeling content includes:
Drug name, specifications, production lot number, date of production, expiration date, storage, packaging, approval number, manufacturer and transportation precautions or other markings.
Drug Administration Law Enforcement Rules
Chapter I General Provisions
Article 1 In accordance with the provisions of the "People's Republic of China **** and the State Drug Administration Law" (hereinafter referred to as the "Drug Administration Law"), the formulation of these measures.
Article 2 These Measures shall apply to all units and individuals concerned with the production, operation, use, testing and scientific research of medicines.
The army's pharmaceutical production enterprises to produce civilian drugs, the application of these measures.
Article 3 The production and operation of medicines shall put social benefits in the first place, and the production, operation and use of counterfeit or inferior medicines are strictly prohibited.
It is strictly prohibited to produce and operate medicines and prepare preparations without authorization.
Chapter II Duties of Drug Supervision and Administration
Article 4 The health administrative department of the State Council shall be in charge of national drug supervision and administration, and its main duties shall be:
(1) to implement the Drug Administration Law and the present Measures;
(2) to draft laws and regulations relating to the supervision and administration of drugs and to formulate complementary individual measures;
(3) to promulgate the China Pharmacopoeia and drug standards;
(4) approving new drugs and issuing drug approval numbers;
(5) supervising the production, operation and use of drugs;
(6) organizing investigations and reevaluations of the efficacy and side-effects of drugs that have already been produced, and providing and releasing timely information on quality;
(7) deciding on administrative measures in accordance with the Drug Administration Law and these Measures;
(8) providing information to the government on drug administration and management;
(9) providing information to the government on drug administration and management; and
(10) providing information to the government on drug administration and management. Management Law" and these measures to decide on administrative penalties.
Pharmaceutical administration agencies of local health administrative departments at all levels above the county level are in charge of drug supervision and management in the administrative areas under their jurisdiction.
Article 5 above the county level health administrative departments set up by the drug testing laboratories, under the leadership of the health administrative departments at the same level, in accordance with the national drug standards and provinces, autonomous regions and municipalities directly under the Central Government of the drug standard for the inspection of drugs.
Article VI of the health administrative departments at or above the county level to set up drug supervisors, national drug supervisors by the State Council health administrative departments to audit and issue certificates; provinces, autonomous regions, municipalities directly under the Central Drug Supervisor and autonomous regions, municipalities or counties, drug supervisors nominated by the administrative department of health, the people's government at the same level to audit and issue certificates.
The duties of drug supervisors by the State Council administrative department of health separately.
Article 7: In the performance of their duties, drug supervisors shall show their credentials, take samples and request relevant information in accordance with the relevant provisions of the State and issue lists. Drug manufacturers and scientific research units to provide confidential technical information, shall bear the responsibility of confidentiality.
The drug supervisor of the provisional sealing of drugs pending processing, should indicate the sealing period, the period shall not exceed 15 days.
Chapter III Procedures for Review and Approval of Licenses
Article 8 The approval procedures stipulated in Article 4, Paragraph 1 of the Drug Administration Law refer to the opening of a drug manufacturing enterprise (including all forms of joint ventures, Sino-foreign equity joint ventures, Sino-foreign cooperative ventures, and foreign-funded enterprises), in addition to fulfilling the procedures for submitting and approving the capital construction in accordance with the state regulations, the following procedures must be fulfilled in turn:
(a) by the enterprise or the enterprise's parent department to the province, autonomous region, municipality directly under the Central Drug Production and Management Department, after examination and approval, sent to the same level of the health administrative department;
(b) by the province, autonomous region, municipality directly under the Central Health Administrative Department for examination and approval, and issued the "Drug Manufacturing Enterprises License".
The competent department for drug production and operation and the administrative department of health shall, within 30 days after each receives all the declaration materials, make a decision on whether to agree or approve.
Article IX of the pharmaceutical production enterprises to set up another branch or set up another workshop outside the plant, by the pharmaceutical production enterprises to the branch or workshop where the competent department of drug production and operation of the province, autonomous region, municipality directly under the Central Government to declare, after examination and consent to send the same level of the health administrative department to apply for the "Drug Manufacturing Enterprises License".
"Drug Manufacturing Enterprise License" shall indicate the branch plant (workshop) and the scope of production.
Article 10 The approval procedure stipulated in Article 10, paragraph 1 of the Drug Administration Law refers to the application for a "Drug Business Enterprise License" by a drug business enterprise (including a franchised or part-time wholesale or retail store or company) in accordance with the following provisions:
(1) An enterprise engaged in the business of wholesaling of pharmaceutical products is examined and agreed to by the competent authority for the production and operation of pharmaceutical products of a province, an autonomous region or a municipality directly under the Central Government
(2) the enterprise operating the retail business of drugs, by the location of the autonomous regions, cities or counties of the competent department of drug production and operation of the examination and consent of the administrative department of health at the same level of examination and approval, issued by the "drug business enterprise license".
The department in charge of drug production and operation and the administrative department of health shall make a decision on whether to give consent or approval within 30 days after each of them receives all the declaration materials.
Article 11 The "competent department for the production and operation of medicines" referred to in Articles 4, 10 and 22 of the Drug Administration Law refers to the departments responsible for the administration of medicines at all levels above the county level or the departments designated by the people's government.
Article XII of the medical unit of self-preparation, must be located in the province, autonomous region, municipality directly under the Central Government health administrative department to apply, after examination and approval of the "preparation license".
The health administrative department accepting the review shall, within 30 days after receiving all the declaration materials, make a decision on whether to approve.
Article XIII of the "Drug Manufacturing Enterprise License", "Drug Business Enterprise License", "Preparation License" is valid for five years.
If the licensee continues to manufacture or operate drugs or prepare preparations after the expiration date, the licensee shall reapply for the license six months before the expiration date, and the procedure for reapplication shall be the same as that for the first application.
Enterprise bankruptcy or closure, the above license shall be surrendered by the original licensing department.
Article 14 The License for Drug Manufacturing Enterprises, the License for Drug Business Enterprises, and the License for Preparations shall be uniformly printed by the health administrative department of the State Council.
Chapter IV Approval of New Drugs
Article 15 The State encourages the research and creation of new drugs, and all drug research units, colleges and universities, drug manufacturers, medical units or individuals who are in a position to do so may engage in the research and creation of new drugs.
Article 16 Approval of new drugs shall be formulated by the health administrative department of the State Council.
Article 17 New drug development units applying for clinical trials of new drugs must submit relevant information and samples in accordance with the provisions of the new drug approval methods.
Article XVIII of the new drug clinical trials or clinical verification, shall be in the province, autonomous region, municipality directly under the Central Government health administrative department approved medical units.
Article 19 The completion of clinical trials or clinical verification and through the provinces, autonomous regions and municipalities directly under the Central Government health administrative department of the new drug, by the research and development unit of the State Council health administrative department for approval. Approved by the health administrative department of the State Council, issued a new drug certificate.
The State Council administrative department of health shall, after receiving all the declaration materials, as soon as possible, the organization of the Drug Review Committee review, and within two months after the review, to make a decision on whether to approve.
Article 20 The health administrative department of the State Council and the provincial, autonomous regions and municipalities directly under the Central Health Administrative Department may set up a drug evaluation committee, the members of the committee consists of medical, scientific research, production, teaching and other aspects of the medical and pharmacological experts.
Article 21 For the development of new drugs or individuals to submit the relevant information, data, processes, etc., clinical trials or validation units, approval departments and their staff shall bear the responsibility of confidentiality.
Chapter V. Approval Numbers of Drugs
Article 22 The production of new drugs by the production unit to the State Council administrative department of health to apply, after examination and approval of the issuance of approval numbers, except for the production of traditional Chinese medicine tablets.
Production of national standards or provinces, autonomous regions and municipalities directly under the Central Government standards of drugs, by the production unit to the provinces, autonomous regions and municipalities directly under the Central Government health administrative department to apply. The administrative department of health shall, after consulting the competent authorities of the same level of drug production and management, decide whether to issue the approval number, except for the production of Chinese medicine tablets.
Article 23 of the drug manufacturers to apply for approval number, should be to the province, autonomous region, municipality directly under the Central Government health administrative department designated by the drug testing center to send test samples and the necessary information, the drug testing center shall make a test report in a timely manner, sent to the health administrative department responsible for the audit. Health administrative department within 30 days of receipt of the test report, to make a decision on whether to issue the approval number.
Article 24 of the approval number of the drug shall not be changed within five years, but discontinued for more than three years of the drug, its approval number is invalid.
Article 25 The health administrative department of the State Council shall organize an investigation of the drugs that have been approved for production; after evaluation by the Drug Review Committee, the approval number shall be revoked for the drugs whose efficacy is uncertain, whose adverse reactions are great, or whose approval number is harmful to people's health for other reasons.
Chapter VI Management of Drug Manufacturing Enterprises
Article 26 The State promotes the Good Manufacturing Practice. The health administrative department of the State Council shall formulate and supervise the implementation of the "Good Manufacturing Practice for Drugs"; the competent department for the production and operation of drugs may, in accordance with the requirements of the "Good Manufacturing Practice for Drugs", formulate an implementation plan to guide the gradual implementation of the "Good Manufacturing Practice for Drugs".
Article 27 The new drug production enterprises and existing enterprises of the expansion and reconstruction part must comply with the "Drug Production Quality Management Standard" requirements. Existing enterprises shall, in accordance with the "Good Manufacturing Practice" requirements, the development and implementation of regulations to ensure the quality of drugs and health requirements, and gradually and systematically to meet the "Good Manufacturing Practice" requirements.
Article 28 A drug manufacturing enterprise shall have full-time technicians and skilled workers, and shall meet the following conditions:
(1) The factory manager responsible for the technology and quality of drug production must be familiar with the knowledge of the business of drug production;
(2) The person in charge of the technical and quality inspection organization for drug production shall, according to the different varieties of the products produced, be a pharmacist, an assistant pharmacist, an assistant pharmacist, a Chinese pharmacist or more than a technical engineer, an engineer, a Chinese pharmacist or more than a technician. engineer, Chinese pharmacist or above;
(iii) the technical person in charge of the workshop shall have a secondary school education or above and more than 5 years of practical experience in production;
(iv) the technical workers of the production shall be technically trained in the production process, and those who are not trained shall not be allowed to operate alone;
(v) if the enterprises of processing of Chinese herbal medicinal tablets are unable to meet the requirements of item (ii), they shall be equipped with the staff who are familiar with medicinal products;
(vi) if the enterprises of processing of Chinese herbal medicinal tablets cannot meet the requirements of item (ii), they shall be equipped with the staff who are familiar with medicinal products. Item requirements, must be equipped with familiar with the nature of the medicine, can identify the authenticity of the herbs, mastery of the production technology and by the health administrative department above the county level to review the registration of pharmaceutical personnel.
Article 29 The pharmaceutical production enterprises must have the ability to ensure the quality of drugs, facilities and sanitation environment, and to maintain a clean and tidy. Preparation of infusion, powder injection, must have ultra-clean conditions.
Article 30 of the drug manufacturers must have the ability to produce drugs for quality inspection of independent organizations and personnel, with appropriate instruments and equipment.
Article 31 The Chinese medicine factory (including the workshop for the production of Chinese medicine in the western medicine factory), in addition to the implementation of the provisions of Articles 28, 29, 30 and 32 in accordance with these Measures, shall also do:
(1) according to the provisions of the different raw herbs for the picking, sorting, washing, drying, concocting, and other pre-processing;
(2) the production of Chinese medicinal preparations of the process (dosing, crushing, internal packaging, etc.) shall not be carried out in an environment that may contaminate the medicines;
(c) Western pharmaceutical factories producing Chinese medicinal preparations shall be equipped with Chinese medicine technicians responsible for quality management.
Article 32 of the pharmaceutical production enterprises to produce a variety of drugs, must be in accordance with the original approved drug standards and process procedures for production, if the change of drug production process procedures may affect the drug standards, shall be reported to the provinces, autonomous regions and municipalities directly under the Central Government health administrative department for examination and approval before proceeding.
Article 33 The drug manufacturer shall have complete production records and inspection records. Records are kept until one year after the expiration of the validity of the batch of drugs; no expiration date, kept for three years.
Article 34 The raw materials and auxiliary materials required for the production of drugs, as well as the containers and packaging materials that are in direct contact with the drugs, shall comply with the National Pharmacopoeia or other medicinal requirements. The use of items without such requirements shall be filed with the local health administrative department.
Article 35 The pharmaceutical production enterprises shall strengthen quality management, pharmaceutical products before leaving the factory must undergo the quality inspection of the enterprise's drug testing organization, meet the standards, shall be attached to the inner packaging with a qualified mark or laboratory report; does not meet the standards, shall not be allowed to leave the factory.
Chapter VII Management of Drug Business Enterprises
Article 36 Drug Business Enterprises shall have full-time pharmacy technicians and meet the following conditions:
(1) Drug wholesalers shall set up a quality inspection organization, which shall be responsible for the technicians above the level of traditional Chinese medicine doctor and pharmacist;
(2) Drug retailers shall be equipped with technicians above the level of traditional Chinese medicine doctor and pharmacist or shall be equipped with technicians above the level of traditional Chinese medicine doctor and pharmacist. Above the technicians, or should be equipped with the county-level health administrative department above the examination and registration of full-time pharmacy staff;
(3) newly recruited and transferred to engage in the pharmaceutical dispensing, acquisition, storage, sales of non-pharmacy technicians, shall be after the enterprise's knowledge of pharmacy training, untrained shall not work alone.
Article 37 The business premises, equipment, storage facilities and hygienic environment of a pharmaceutical enterprise shall meet the following requirements:
(1) The storage and custody of medicines must comply with the physical and chemical properties of various types of medicines. There should be dust, moisture, pollution, insect moths, rodent bites, mold and mildew measures. Need to avoid light, low-temperature storage of drugs, there should be appropriate special library (cabinet) preservation;
(2) drug business enterprises operating non-pharmaceuticals, must be set up in another part of the merchandise cabinet, shall not be mixed with drugs.
Article 38 of the drug business enterprises, in addition to processing of Chinese medicine tablets, concoctions, and in accordance with the prescription on behalf of the patient preparation, shall not be made into medicines for sale.
Article 39 The acquisition and sale of drugs business enterprises must establish and improve the strict quality inspection and acceptance of storage, maintenance, storage and distribution system.
Article 40 The acquisition of drugs, must be checked and accepted. Inspection and acceptance include: the name of the drug, the production company, production batch number, certificate of conformity, approval number, registered trademark, packaging and the appearance of the quality of drugs. The Chinese herbal medicine must check the packaging, each package must indicate the name, origin, transfer unit, and with a quality mark.
Chapter VIII Pharmaceutical Management of Medical Units
Article 41 of the preparation of medical units must have the following conditions:
(a) county-level hospitals (including more than 100 beds of factories, mines, enterprises and public institutions of medical units) of the preparation, the person in charge of the business of drug testing, shall be pharmacist or more than a technician;
county-level hospitals below the preparation, Pharmaceutical inspection of the person in charge of the business, shall be a pharmacist above the technical staff;
(ii) the preparation of premises should be able to ensure the quality of medicines, housing and equipment, and to maintain a clean and tidy. Sterilized preparation room should have dressing, buffering, washing, preparation, filling, sterilization, packaging and other appropriate conditions and air-conditioning and other facilities. Preparation of infusion agents, must have ultra-clean conditions.
Article 42 The preparation of preparations to strictly implement the operating procedures, quality inspection and hygiene system. Each batch of preparations must have detailed and complete records.
Article 43 of the preparation of preparations for medical units must have the appropriate drug testing room.
The quality of the preparation by the inspection, issued by the pharmacy inspection room preparation certificate, with a doctor's prescription for use; unqualified, are not allowed for clinical use.
Article 44 The preparations made by the medical units are limited to the clinical and scientific research needs of the unit and the market is not available or insufficient supply of drug preparations.
The preparations prepared by the medical units shall not be sold in the market or sold in disguise.
Article 45 of the medical unit preparation, must be in accordance with the provinces, autonomous regions and municipalities directly under the central health administrative department of the hospital preparation specifications formulated, and to the local health administrative department for the record.
Article 46 of the medical unit in addition to the pharmacy department (room), isotope room (nuclear medicine room) can be dispensed, supply of drugs, other departments are not allowed to dispense, supply of drugs.
Chapter IX Penalties
Article 47 In addition to the violation of Article 15 of the Drug Administration Law, Chapter VIII of the administrative penalties related to the provisions of the advertising management, by the decision of the administration for industry and commerce, the administrative penalties provided for in the Drug Administration Law and the present Measures shall be decided by the administrative departments of the health sector at or above the county level, and issued a written notice of penalties. Penalty notice for counterfeit and substandard drugs shall contain the results of the quality inspection of drug testing laboratories.
The proceeds of the fine shall be paid in full to the state treasury.
Article 48 For the production, sale and use of counterfeit medicines, the counterfeit medicines and illegal income shall be confiscated, and the administrative department of health may, according to the circumstances, impose a fine of up to five times the price of the batch of counterfeit medicines pretending to be genuine.
Article 49 For the production, sale and use of inferior medicines, confiscate the inferior medicines and illegal income, the administrative department of health according to the circumstances, may impose a fine of up to three times the price of the batch of inferior medicines equivalent to the genuine ones.
Article 50 The production, sale or use of counterfeit or substandard medicines in any of the following circumstances shall be regarded as a serious case, and the administrative department of health shall impose heavier administrative penalties:
(1) Counterfeiting of narcotic, psychotropic, toxic, or radioactive medicines as other medicines, or counterfeiting of other medicines as the said medicines; and
(2) Counterfeiting of the medicines being produced and sold, substandard drugs with infants and young children as the main target of use;
(iii) the production, sale or use of counterfeit or substandard drugs has caused the consequences of human injuries;
(iv) the production, sale or use of counterfeit or substandard drugs, and the recidivism of the offenders after treatment;
(v) other laws and regulations of the State shall be subject to heavier penalties.
Article 51 Where a person produces or operates drugs or formulates preparations without obtaining a Drug Manufacturer's License, a Drug Operator's License, or a Preparation License, the administrative department of health shall, in addition to ordering the person to immediately cease production, business, or preparation, confiscate all the drugs and the illegal proceeds, and, depending on the circumstances, impose a fine of five times the price of the genuine product of the drugs or preparations he produces or operates, or a fine of The fine shall be less than five times the price of the genuine drugs or preparations produced or operated by them.
Article 52 The administrative department of health may, depending on the circumstances, issue a warning or impose a fine of not more than 20,000 yuan to any unit or individual in any of the following cases:
(1) the first importation of medicines has not been approved by the administrative department of health of the State Council;
(2) imported medicines have not been examined by the pharmaceutical inspection office at the border crossing;
(3) unauthorized clinical trials of new medicines or unauthorized testing of new medicines or unauthorized testing of new medicines. Unauthorized clinical trials or validation of new drugs;
(iv) without the approval of the administrative department of health, unauthorized changes in the production process procedures, resulting in changes in the standard of the drug;
(v) medical units of homemade preparations for sale in the market or disguised sales.
Article 53 For any of the following circumstances of the unit or individual, the administrative department of health may, depending on the circumstances, impose a warning, or impose a fine of up to 10,000 yuan:
(1) should indicate the expiration date of the drug is not indicated;
(2) violation of the packaging of medicines or violation of the packaging of the shipment of Chinese herbal medicines;
(3) medicine Packaging is not in accordance with the provisions of the labeling or labeling, the contents of the instructions do not comply with the provisions;
(d) unauthorized acquisition, sale without examination and approval of the newly discovered or introduced from abroad Chinese herbal medicine.
Article 54 The staff of the Drug Inspection Institute and drug supervisors to use their powers to favoritism, accepting bribes, the circumstances are minor, the administrative department of health shall be given administrative sanctions; the circumstances are serious constitutes a crime, shall be investigated for criminal responsibility.
Chapter X By-laws
Article 55 The labeling of narcotic drugs, psychotropic drugs, toxic drugs, radiopharmaceuticals and medicines for external use shall be stipulated as follows (see attached chart).
Article 56 These Measures shall be interpreted by the health administrative department of the State Council.
Article 57 These Measures shall come into force on the date of publication.
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