| shall be defined separately by the administrative department of health under the State Council.
Article 7
When carrying out their duties, the medicine supervisors are required to present their credentials before they take sample testing and ask for relevant technical data, with a receipt in accordance with the state stipulations. They are required to keep confidential the technical data provided by the production enterprise and scientific research unit. The medicine supervisors may temporarily seal up some medicine pending further settlement. It is required of them to state the term of sealing up which shall not normally exceed 15 days.
Chapter III Procedure for the Verification and Approval of Li- censes
Article 8
The procedures for examination and approval as stipulated in Paragraph 1 of Article 4 of the Pharmaceutical Administration Law denote that the establishment of a pharmaceutical producing enterprise (including all forms of inland associated enterprises, Chinese-foreign equity joint ventures and contractual joint ventures and foreign invested enterprises) shall involve, in addition to applying for approval for the capital construction of the enterprise in accordance with state stipulation, the following steps: (1) the enterprise or its leadership organ submits an
application to the competent department for the production and trading of pharmaceuticals of the province, autonomous region or municipality directly under the Central Government where the enterprise is located for examination and approval and then refer it to the administrative department of health at the same level. (2) upon approval by the administrative department of health of the province, autonomous region or municipality directly under the Central Government, a Pharmaceutical Producer License shall be issued. The department in charge of the production and trading of pharmaceuticals and the administrative
department of health are required to make a decision within 30 days of receipt of complete application materials.
Article 9
If a pharmaceutical production enterprise desires to set up a branch factory or any additional workshops outside the premise of the factory, it is required to submit an application to the department in charge of the production and trading of pharmaceuticals at the level of the province, autonomous region or municipality directly under the Central Government for examination and approval and then refer it to the administrative department of health at the same level for a Pharmaceutical Producers License, on which the status of the new set-up (a branch factory or a workshop) and its production scope must be clearly stated.
Article 10
The procedures for examination and approval stipulated in Paragraph 1 of Article 10 of the Pharmaceutical Administration Law denote that a pharmaceutical trading enterprise (including specialized and non- specialized whole-sale or retail drug stores or companies) should apply for a Pharmaceutical Trading Enterprise License in accordance with the following provisions:(1) for a wholesale drug enterprise, an application must be submitted to the department in charge of the production and rading of pharmaceuticals at the level of the province, autonomous region or municipality directly under the Central Government for examination and approval and then be
referred to the administrative department of health at the same government level for verification and approval before a Pharmaceutical Trading Enterprise License is issued;(2) for a retail drug enterprise, an application must be submitted to the
department in charge of the production and trading of pharmaceuticals at the autonomous prefecture, municipality or county government level for examination and approval and then be referred to the administrative department of health at the same government level for verification and approval before a Pharmaceutical Trading Enterprise License is issued. The department in charge of the production and trading of pharmaceuticals and the administrative department of health are required to make a decision within 30 days of receipt of complete application materials.
Article 11
The competent department for the production and trading of pharmaceuticals stated in Articles 4, 10 and 22 of the Pharmaceutical Administration Law refers to those pharmaceutical administration organs or departments appointed by the people’s government at or above the county level.
Article 12
If a medical treatment unit needs to prepare some medicaments, it is required to submit an application to an administrative department of health at the level of the province, autonomous region or municipality directly under the Central Government for examination and approval before a Dispensing Permit is granted.
The administrative department of health is required to make a decision within 30 days of receipt of complete application materials.
Article 13
The term of validity for a Pharmaceutical Producer Licence, a Pharmaceutical Trading Enterprise Licence, or a Dispensing Permit is 5 years. If the licensee wishes to continue its production or trading or making medicament preparation upon expiration of the licence, it must reapply for permission. The entire application procedures must be repeated. If an enterprise has gone bankrupt or has wound up business, the license it is holding should be cancelled by the administrative department of health that has issued it.
Article 14
Pharmaceutical Producer Licence, Pharmaceutical Trading Enterprise Licence, and Dispensing Permit shall be printed exclusively by the administrative department of health under the State Council.
Chapter IV Examination and Approval of New Medicines
Article 15
The state encourages research in and development of new medicines. All pharmaceutical research units, medical colleges, pharmaceutical production enterprises, medical treatment units or individuals with the necessary conditions are encouraged to engage in the research in and development of new medicines.
Article 16
Procedures for the examination and approval of new medicines shall be formulated by the administrative department of health under the State Council.
Article 17
Before a new medicine is put to clinical testing, the research and development unit of this medicine is required to submit an application together with the relevant data and samples in accordance with the provisions for the examination and approval of new medicines.
Article 18
Clinical testing or clinical verification of a newly developed medicine must be conducted in the medical treatment unit(s) approved by the administrative department of health at the level of the province, autonomous region or municipality directly under the Central Government.
Article 19
After new medicines have been clinically tested and verified and have passed the primary examination by the administrative departments of health at the level of the province, autonomous region or municipality directly under the Central Government, the research and development unit of these new medicines shall submit an application to the administrative department of health under the State Council for examination and approval and New Medicine Certificates shall be issued accordingly. The administrative department of health under the State Council is required to call, at the earliest possible time, the Medicine Appraisal Committee to make technical appraisal of the newly developed medicine after the complete application materials are received. A decision must be made within two months of the technical appraisal.
Article 20
The administrative department of health under the State Council and those in the provinces, autonomous regions or municipalities directly under the Central Government may set up a Medicine Appraisal Committee which is composed of experts in medical science and pharmacology from medical treatment units, scientific research units, pharmaceutical factories and medical colleges.
Article 21
The clinical testing or clinical verification unit, the department to examine and approve the newly developed medicine and individuals so involved are required to keep confidential the relevant data, figures, production techniques provided by a unit or individual that has developed the new medicine.
Chapter V Registered Document of Approval for Medicines
Article 22
For the production of a new medicine, the production unit shall submit an application to the administrative department of health under the State Council for examination and approval upon which a Registered Document of Approval shall be issued to the unit. However, this does not apply to the production of traditional Chinese medicine in ready-to-use forms. To produce a certain kind of medicine for which the state, the province, autonomous region or municipality directly under the Central Government
has already set standards, the production unit is required to submit an application to the administrative department of health at the level of the province, autonomous region or municipality directly under the Central Government. After consulting the department in charge of the production and trading of pharmaceuticals at the same level, the administrative department of health shall make a decision on whether to issue the Registered Document of Approval to the unit. However, this does not apply
to the production of traditional Chinese medicine in ready-to-use forms.
Article 23
When applying for a Registered Document of Approval for a medicine, the production unit must present testing samples and relevant data to the medicine inspection organ appointed by the administrative department of health at the level of the province, autonomous region or municipality directly under the Central Government. The medicine inspection organ is required to make a test report and refer it to the administrative department of health for examination and approval, which shall, within 30 days of receipt of the test report, make a decision on whether to issue
共4页 上一页 1 2 3 4 下一页 |
