Laws of the People's Republic of China

State Food and Drug Administration

Order of the State Food and Drug Administration

No. 24

The Provisions Governing Pharmaceutical Directions and Labels, which were deliberated and adopted at the executive meeting of the State Food and Drug Administration on March 10, 2006, are hereby promulgated, and shall come into force as of the date of June 1, 2006.

Director General Shao Mingli

March 15, 2006

Provisions Governing Pharmaceutical Directions and Labels

Chapter I General Provisions

Article 1

For the purpose of regulating the administration of pharmaceutical directions and labels, the present Provisions are formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China and the Regulations for the Implementation of the Pharmaceutical Administration Law of the People's Republic of China.

Article 2

The directions and labels of the pharmaceuticals sold on market within the territory of the People's Republic of China shall meet the requirements in the present Provisions.

Article 3

Pharmaceutical directions and labels shall be subject to the ratification of the State Food and Drug Administration.

The labels of a pharmaceutical shall be based on the directions, and the contents thereof shall not exceed the scope of directions, and may not be printed with any word or mark that implies the curative effect, misleads the usage or inappropriately advertises the product.

Article 4

The package of a pharmaceutical must be printed or affixed with the label according to the Provisions, and shall not carry any other literal or video materials or other information that advertises the product or the enterprise.

The smallest packages produced by a pharmaceutical manufacturing enterprise for sale on the market must be attached with directions.

Article 5

The literal expression in pharmaceutical directions and labels shall be scientific, regular and accurate. The directions of an OTC pharmaceutical shall use the literal expression easy to understand in addition, so that the patients may identify, choose and use the pharmaceutical by themselves.

Article 6

The words in pharmaceutical directions and labels shall be clear and easily identifiable, and the marks shall be clear and eye-catching, and no printed word shall be missing or loosely affixed, nor shall any mark be amended or supplemented by means of affixation, cutting or alteration, etc.

Article 7

Pharmaceutical directions and labels shall use regular Chinese characters promulgated by the State Language Commission. If the same contents are simultaneously expressed in both Chinese and another language, the Chinese expression shall prevail.

Article 8

With a view to protecting public health and guiding correct use of medicine, a pharmaceutical manufacturing enterprise may take initiative to add cautions on the pharmaceutical directions or labels, and the State Food and Drug Administration may also require pharmaceutical manufacturing enterprises to add cautions on directions or labels.

Chapter II Pharmaceutical Directions

Article 9

The directions of a pharmaceutical shall include important scientific data, conclusion and information on its safety and effectiveness, so as to guide the safe and reasonable usage of the pharmaceutical. The specific format, contents and writing requirements of the pharmaceutical directions shall be formulated and promulgated by the State Food and Drug Administration.

Article 10

The expression in the directions of a pharmaceutical for the name of a disease, the professional pharmacological terms, the name of a pharmaceutical, and the name and result of the clinical examination shall use the special words uniformly promulgated or regularized by the state, and the metrological units shall meet the national standards.

Article 11

The directions of a pharmaceutical shall list all active ingredients or the medical herbs of composite prescriptions. The injections and OTC pharmaceuticals shall list the names of all supplementary materials in use in addition.

Where a pharmaceutical prescription contains any ingredient or supplementary material that might cause a serious adverse reaction, the matter shall be stated.

Article 12

A pharmaceutical manufacturing enterprise shall actively trace the safety and effectiveness of a pharmaceutical on market, and shall file an application in time when it is necessary to amend the pharmaceutical directions.

The State Food and Drug Administration may also require the pharmaceutical manufacturing enterprise to amend the pharmaceutical directions on the basis of the information on the results from monitoring of adverse reactions of a pharmaceutical, or from re-assessment of the pharmaceutical, etc..

Article 13

After the amendment of directions of a pharmaceutical are approved, the pharmaceutical manufacturing enterprise shall immediately notify the relevant pharmaceutical trading enterprises, the using entities and other relevant departments of the amended contents, and timely use the amended directions and labels according to the requirements.

Article 14

The directions of a pharmaceutical shall contain full information on adverse reactions of the pharmaceutical, and indicate the adverse reactions in details. The adverse consequences caused therefrom shall be borne by the manufacturing enterprise if the pharmaceutical manufacturing enterprise fails to timely amend the directions according to the safety and effectiveness of the pharmaceutical on market or fails to fully state the adverse reactions of the pharmaceutical in directions.

Article 15

The dates of ratification and amendment of the directions of a pharmaceutical shall be both indicated on an eye-catching position in the directions.

Chapter III Labels of Pharmaceuticals

Article 16

The labels of a pharmaceutical shall refer to the contents printed or affixed on the packages of the pharmaceutical, which includes interior labels and exterior labels. The interior labels of a pharmaceutical shall refer to the labels on the packages that are in direct contact with the pharmaceutical, while the exterior labels shall refer to the labels on other packages out of the interior label.

Article 17

The interior labels of a pharmaceutical shall include such contents as the general name of the pharmaceutical, indications or functions, specifications, usage, dosage, date of production, product batch number, valid term and manufacturing enterprise, etc.

Where the package size is too small and the aforesaid contents cannot be fully indicated, the contents such as the general name of the pharmaceutical, specifications, product batch number, and valid term shall be indicated as a minimum requirement.

Article 18

The exterior labels of a pharmaceutical shall indicate such contents as the general name of the pharmaceutical, ingredients, character, indications or functions, specifications, usage, dosage, adverse reactions, contraindication, precautions, storage, date of production, product batch number, valid term, approval number, and manufacturing enterprise, etc. If the indications or functions, usage, dosage, adverse reactions, contraindication and precautions cannot be fully indicated, the main contents and the words "see directions for details" shall be indicated.

Article 19

The labels of the packages used for transport and storage shall at least indicate the general name of the pharmaceutical, specifications, storage, date of production, product batch number, valid term, approval number and manufacturing enterprise, and may also indicate necessary contents such as the package quantity, precautions for transport or other marks when necessary.

Article 20

The labels of a raw material medicine shall indicate the name of the medicine, storage, date of production, product batch number, valid term, applicable standards, approval number, and manufacturing enterprise, and shall indicate necessary contents such as the package quantity and precautions for transport at the same time.

Article 21

For the same pharmaceutical manufactured by the same pharmaceutical manufacturing enterprise, the contents, format and color of the label must be consistent with each other if the pharmaceutical specifications and the package specifications are the same; on the other hand, the labels shall be distinctively different, or the difference shall be explicitly indicated in the specifications if the pharmaceutical specifications and the package specifications are different.

Where the same pharmaceutical manufactured by the same pharmaceutical manufacturing enterprise is managed separately as both prescription pharmaceutical and OTC pharmaceutical, the packages and colors of both shall be distinctive from each other.

Article 22

For a pharmaceutical with particular storage requirements, such requirements shall be indicated at an eye-catching position on the label.

Article 23

The valid term on a pharmaceutical label shall be indicated in a sequence of "year, month and date". The year shall be expressed with four numerals, while both the month and the date shall be expressed with two numerals. The specific format shall be "valid up to (กมกมกมกมyear)/(กมกมmonth)" or "valid up to (กมกมกมกมyear)/(กมกมmonth)/(กมกมdate)"; or may be expressed with numerals and other symbols as "valid up to กมกมกมกม.กมกม." or "valid up to กมกมกมกม/กมกม/กมกม", etc.ical product for preventive use shall be indicated in light of the standards approved by the State Food and Drug Administration for registration, and the valid term of a biological product for curative use shall be counted as of the date of dispensation. The valid term of any other pharmaceutical shall be counted as of the date of production.

If the year, month and date of a valid term are all indicated, the indicated expiry date shall be the day corresponding to that before the beginning date, while if only the year and month are indicated, the indicated expiry month of shall be the month corresponding to that before the beginning month.

Chapter IV Use of Names and Registered Trademarks of Pharmaceuticals

Article 24

The name of pharmaceutical indicated in pharmaceutical directions and labels must conform to the principles promulgated by the State Food and Drug Administration on giving general names and commodity names to pharmaceuticals, and shall be consistent with the corresponding contents in the pharmaceutical approval certificates.

Article 25

The general name of a pharmaceutical shall be distinct and prominent, and the style, size and color of the characters shall conform to the following requirements:

(1)

The general name must be indicated at a distinct position within the scope of the upper one-third part for those with horizontal labels; and the general name must be indicated at a distinct position within the scope of the right one-third part for those with vertical labels;

(2)

No grass style, seal character or other style difficult to identify shall be used, nor shall any italic, hollow or shadow form, etc. be used to decorate the style;

(3)

The color of the characters shall be black or white, so as to form an intense contrast with their corresponding light or dark background; and

(4)

It shall not be written in different lines unless it is unable to be written in one line due to restriction of the package size.

Article 26

The commodity name of a pharmaceutical shall not be written with the general name in the same line, its style or color shall not be more distinct or prominent than the general name, and the average character area size of the commodity name shall not be larger than a half of that of the general name.

Article 27

It is prohibited to use any unregistered trademark or any other pharmaceutical name not approved by the State Food and Drug Administration in pharmaceutical directions and labels.

Where a pharmaceutical label uses a registered trademark, the said trademark shall be printed at the border corner of the pharmaceutical label. If any words are included, the average character area size shall not be larger than one fourth of that of the general name.

Chapter V Other Provisions

Article 28

Where a narcotic drug, psychotropic drug, toxic drug for medical use, radioactive drug, pharmaceutical for external use, or nonprescription pharmaceutical is required by any state provision to be attached with a special mark, its directions and labels must be printed with the prescribed mark.

Where the state has particular provisions on pharmaceutical directions and labels, such provisions shall prevail.

Article 29

The provisions on the administration of labels of traditional Chinese medicinal materials, herbal medicines for decoction shall be separately formulated by the State Food and Drug Administration.

Article 30

Where the directions or labels of a pharmaceutical do not conform to the present Provisions, the pharmaceutical manufacturing enterprise involved shall be penalized in accordance with the relevant provisions of the Pharmaceutical Administration Law of the People's Republic of China.

Chapter VI Supplementary Provisions

Article 31

The present Provisions shall come into force as of the date of June 1, 2006. The Provisions on the Administration of Pharmaceutical Package, Label and Directions (for Trial Implementation) promulgated by the State Drug Administration on October 15, 2000 shall be repealed simultaneously.