How special are the packaging and labeling of special items?

What are “special items”

Microorganisms: including viruses, bacteria, fungi, actinomycetes, rickettsia, spirochetes, chlamydia, mycoplasma and other medical microbial (virus) species and samples, as well as parasites and environmentally friendly microbial agents;

Human tissues: including human cells, cell lines, embryos, organs, tissues, bone marrow, secretions, excretions, etc.;

Biological products: including vaccines, antitoxins, diagnostic reagents, cytokines, enzymes and their preparations used in human medicine and life science related fields, as well as toxins, antigens, antibodies, antigen-antibody complexes, allergens, nucleic acids, immunomodulators, microecological preparations and other biologically active preparations;

Blood and its products: including human whole blood, plasma components, special blood components, and various human plasma protein products.

The “specialness” of packaging requirements

(1) The operating units using special items entering and leaving the country and the third-party packaging or transportation companies entrusted by them should ensure that the packaging and labeling of special items comply with the requirements of relevant laws and regulations.

(2) The product packaging of special items entering or leaving the country must be waterproof and leakproof and affixed with appropriate labels indicating the contents. The outer side of the inner packaging of high-risk special items must be wrapped with sufficient absorbent materials so that all spilled liquids can be absorbed when the inner packaging is broken or leaked.

Note:

Transport packaging classification: According to the classification and packaging requirements of ICAO

document Doc9284 “Technical Instructions for the Safe Transport of Dangerous Goods by Air”,

the relevant pathogens and standards are divided into two categories, A and B, and the corresponding

UN numbers are UN2814 (animal viruses are UN2900) and UN3373. For Class A infectious substances,

if “only virus cultures” is not indicated in the table, all materials related to the virus are included; for Class

A infectious substances indicated as “only virus cultures”, virus cultures are packaged according to

UN2814, and other specimens are packaged according to UN3373 requirements. All viruses and related

specimens marked as Class B are packaged and transported by air according to the requirements of

UN3373. For transportation by other means of transportation, the above standards can be referred to for

packaging.

“Speciality” of labeling requirements

The outer packaging label of special items should have the product name in Chinese or English. If there is

a biosafety risk, it should have a biohazard label that meets the relevant requirements.

(2) The packaging label of special items entering the country for sale should have the product name,

manufacturer name and address in Chinese. If it is necessary to indicate the product specifications, grade,

name and content of the main ingredients contained in the product according to the characteristics and

usage requirements of the product, it should be indicated in Chinese accordingly.

(3) The packaging of special items that are commercialized abroad and entered for scientific research

should have the name and specifications in Chinese or English, and indicate “for scientific research use

only”.

(4) For special items that are not commercialized abroad and cannot be labeled due to the small surface

area of ​​the product packaging, product materials containing the above information should be attached,

but at least the product name should be included.