Interpretation of the Working Opinions on Issues Related to Entrusted Storage and Distribution of Drugs and GSP Certification in Pharmaceutical Trading Enterprises

Source: Food and Drug Administration of Guizhou Province

 

After the issuance of the working opinions on the entrusted storage and distribution of drugs and GSP certification of drug trading enterprises (No. 85 [2015]), it has played a positive role in further standardizing the drug trading behavior. However, in some places, there is still a gap in understanding between the documents of the former national bureau and the documents of the provincial bureau. In order to enable drug circulation regulatory agencies and enterprises at all levels to better comply with the provisions of GSP in relevant business activities, the relevant contents of the document "Guizhou Food and Drug Administration Pharmaceutical Chemical Flow No. 85 [2015]" are now interpreted.

1. basis for drafting this document

Since the state has no new regulations on the development of modern pharmaceutical logistics (corresponding regulations are being formulated), in order to further improve the supervision of pharmaceutical circulation in our province and promote the development of the big health industry, this article is drafted in accordance with Article 3 of the Opinions on Strengthening Drug Supervision and Administration to Promote the Development of Modern Drug Logistics issued by the State Food and Drug Administration (State Food and Drug Administration [2005] No. 160) and Article 1 of the Notice on Relevant Issues of Opinions on Strengthening Drug Supervision and Administration to Promote the Development of Modern Drug Logistics (State Food and Drug Administration [2005] No. 318), it is only a clear emphasis on the management provisions of the documents of the National Bureau.

Information required for 2. distribution

When it is necessary to entrust storage and distribution, it is necessary to check whether the business scope of the entrusted party's business license is consistent with the business scope to be entrusted. If so, it is necessary to check whether the entrusted party is a pharmaceutical wholesale enterprise approved by the provincial bureau and basically has the conditions of modern pharmaceutical logistics to obtain the qualification of storage and distribution.

The principle of 3. entrusted distribution needs to master

The entrusting enterprise should be a temporary entrustment for reasons such as relocation, renovation or increase in business volume. It must be moved back after its own storage system is perfected. Therefore, the entrusting enterprise must have its own storage system and office space, and cannot cancel the corresponding system on the grounds of entrustment, that is, it must meet the requirements of GSP. At the same time, a time limit has been imposed on the entrusted behavior, that is, the entrusted distribution period is one year. If the entrusted distribution needs to continue after reaching the end of the year, it shall be declared in accordance with the procedures, and the summary of the entrusted storage and distribution work of the previous year shall be submitted at the same time. If the entrusted storage and distribution meet the requirements after examination, the entrusted storage and distribution can continue.

Approval of the Ministry of 4. on the storage and distribution entrusted by enterprises.

1. Materials to be submitted for the application for entrusted storage and distribution of drugs:(1) Application for entrustment (Annex 1);(2) Agreement between the entrusted and entrusted parties;(3) Drug quality guarantee for the entrusted and entrusted parties;(4) Copies of "Drug Business Enterprise License", "GSP Certificate" and "Business License" of the entrusted and entrusted parties;(5) the entrusting party to the entrusted party storage, distribution conditions assessment materials;(6) entrusted distribution of drug retail chain enterprise pharmacies (including directly affiliated stores and franchise stores) record form (Annex 2).

2. If the entrusted and entrusted enterprises are in the same area (the same city or state), they shall be examined and approved by the municipal (state) bureau in accordance with the procedures and reported to the provincial bureau for the record; if the entrusted and entrusted enterprises cross cities (states), the entrusted storage and distribution enterprises shall first submit the application materials to the local city (state) Food and Drug Administration for examination and approval, and the enterprise entrusted with storage and distribution shall apply to the Provincial Food and Drug Administration, which shall be approved for implementation after on-site inspection and examination by the Provincial Bureau.

3. If the entrusting party and the entrusted party are the same legal person, they shall also be handled in accordance with the above procedures.

Attachment: Working Opinions on Entrusted Storage and Distribution of Drugs and GSP Certification of Pharmaceutical Trading Enterprises (No. 85 [2015] of Guizhou Food and Drug Administration)

 

Guizhou Food and Drug Administration

March 15, 2017

 

 

Annex

Documents of Guizhou Food and Drug Administration

Qian Food and Drug Administration Drug-chemical Flow No. 85 [2015]

Working Opinions on Entrusted Storage and Distribution of Drugs and GSP Certification in Drug Trading Enterprises

Municipal (prefecture) Food and Drug Administration, Gui'an New District Food and Drug Administration, Renhuai City, Weining County Market Supervision Administration:

Recently, Zunyi Food and Drug Administration reported the "Request for Instructions on Entrusting Drug Wholesale Enterprises for Distribution and GSP Certification by Drug Retail Enterprises". After research by the Provincial Bureau, the following opinions on relevant issues are put forward. Please follow them:

1. on entrusted distribution of drugs

(I) the relevant policies of the State Administration. According to the opinions of the State Administration on strengthening Drug Supervision and Administration and promoting the Development of Modern Drug Logistics (State Food and Drug Administration [2005] No. 160), "Drug wholesale enterprises with modern drug logistics conditions are encouraged to promote standardization and scale through merger, reorganization and joint development, so as to make enterprises bigger and stronger. It is allowed to accept the entrustment of licensed pharmaceutical enterprises to carry out drug storage and distribution services. The entrusted and entrusted pharmaceutical wholesale enterprises shall apply to the provincial pharmaceutical supervisory and administrative departments. For cross-jurisdictional applications for entrustment, both the entrusting enterprise and the entrusted enterprise shall apply to the provincial drug supervision and administration department where the entrusted enterprise is located, and file with the provincial drug supervision and administration department where the entrusted enterprise is located. The scope of drugs entrusted for storage and distribution shall be consistent with the business scope of the entrusting enterprise. The entrusted pharmaceutical trading enterprise must have the storage and distribution conditions required for the entrusted storage and distribution of pharmaceutical characteristics. The two parties shall sign a valid contract, which shall include the scope of entrusted storage and distribution of drugs, quality responsibility, entrustment period and so on. The follow-up inspection of the drug regulatory department's implementation of the drug business quality management norms should include the inspection of the entrusted enterprise" and "Notice on Relevant Issues Concerning the Opinions on Strengthening Drug Supervision and Administration and Promoting the Development of Modern Drug Logistics" (State Food and Drug Administration [2005] No. 318) "In order to encourage and standardize the development of modern drug logistics, our bureau issued the" Opinions on Strengthening Drug Supervision and Administration to Promote the Development of Modern Drug Logistics "(State Food and Drug Administration [2005] No. 160). The food and drug supervision and management departments in various regions should carefully study and understand the spirit of the document, attach great importance to it, and develop ideas., Actively explore, combine actual conditions, and carry out pilot work" regulations, which are now clear as follows:

1. The scope of drugs entrusted for storage and distribution shall be consistent with the business scope of the entrusted enterprise;

2. The enterprises entrusted with distribution are pharmaceutical wholesale enterprises with modern logistics system devices and equipment that can ensure the quality of drugs.

Approval of the (II) on the storage and distribution entrusted by the enterprise.

1. Materials to be submitted for the application for entrusted storage and distribution of drugs:(1) Application for entrustment (Annex 1);(2) Agreement between the entrusted and entrusted parties;(3) Drug quality guarantee for the entrusted and entrusted parties;(4) Copies of "Drug Business Enterprise License", "GSP Certificate" and "Business License" of the entrusted and entrusted parties;(5) the entrusting party to the entrusted party storage, distribution conditions assessment materials;(6) entrusted distribution of drug retail chain enterprise pharmacies (including directly affiliated stores and franchise stores) record form (Annex 2).

2. If the entrusted and entrusted enterprises are in the same area (the same city or state), they shall be examined and approved by the municipal (state) bureau in accordance with the procedures and reported to the provincial bureau for the record; if the entrusted and entrusted enterprises cross cities (states), the entrusted storage and distribution enterprises shall first submit the application materials to the local city (state) Food and Drug Administration for examination and approval, and the enterprise entrusted with storage and distribution shall apply to the Provincial Food and Drug Administration, which shall be approved for implementation after on-site inspection and examination by the Provincial Bureau.

3. If the entrusting party and the entrusted party are the same legal person, they shall also be handled in accordance with the above procedures.

4. The entrusted distribution period is one year. If it is necessary to continue entrusted distribution after reaching the age of one year, it shall be declared in accordance with the procedures, and a summary of the entrusted storage and distribution work of the previous year shall be submitted at the same time. If it meets the requirements after examination, the entrusted storage and distribution can continue.

(III) on the entrusted distribution enterprise GSP certification inspection.

1, entrusted storage and distribution enterprises are wholesale enterprises by the provincial bureau organization certification;

2. If the entrusted enterprise is a retail chain enterprise, the municipal (state) bureau shall conduct certification inspection (including its warehouse) in strict accordance with the "Guiding Principles for On-site Inspection of Pharmaceutical Business Quality Management Standards" (Part II Pharmaceutical Retail Enterprises);

3, on the entrusting party and the trustee belong to the same legal person enterprise GSP certification issues. The provincial bureau is responsible for the certification inspection of the wholesale part, and the municipal (state) bureau is responsible for the certification inspection of the retail chain part, because the warehouse part has been certified by the provincial bureau, the municipal (state) bureau may no longer certify its warehouse. However, the quality directors of each department shall not work part-time with each other.

2. issues related to drug retail chains

According to the spirit of the Provincial Bureau's Opinions on Promoting the Development of the Pharmaceutical Retail Chain Industry (No. 646 [2014] of Guizhou Food and Drug Administration), the opening of pharmaceutical retail chain stores is emphasized as follows:

1. Staffing conditions: In view of the lack of licensed pharmacists in our province, new chain stores of pharmaceutical retail chain enterprises can be equipped with resident pharmacists or legally recognized pharmaceutical technical professionals (including nationally recognized licensed pharmacists, competent pharmacists and other personnel with technical titles above) as one of the starting conditions;

2. Conditions for the number of stores: specify that the number of stores of drug retail chain enterprises is more than 10 (including franchise stores);

3. Store distance conditions: According to the relevant provisions of relevant laws and regulations such as the Administrative Licensing Law, the distance between stores is not limited;

4. Monthly report filing: After being approved by the municipal (state) bureau according to law, the drug retail chain enterprise shall report to the provincial bureau for filing (including electronic version) within one month for summary reporting.

Relevant Issues of 3. on Pharmaceutical Retail Enterprises

1. In view of the actual situation in our province, for the drug retail enterprises that have been established in our province, the person in charge of quality can be the resident pharmacist, valid for three years;

2. Newly established drug retail enterprises dealing in prescription drugs and Class A non-prescription drugs shall, in accordance with Article 5 of the measures for the Administration of Drug Business license, be equipped with licensed pharmacists or other competent pharmacists who have been qualified in accordance with the law;

3. Pharmaceutical retail enterprises operating Class B over-the-counter drugs and those setting up pharmaceutical retail enterprises in areas below rural villages and towns shall be equipped with in-store pharmacists and other pharmaceutical professionals, and licensed pharmacists if conditions permit;

4. The municipal (state) bureau reports the changes in the number of drug retail enterprises to the provincial bureau every six months (Annex 3). At the same time, the approval of retail drugs shall be submitted to the provincial bureau for filing before June 30 and December 30 each year.

Issues related to the regulation of drug business in 4.

1. Drug wholesale enterprises: the provincial food and drug administration is responsible for examination and approval and GSP certification inspection, and arranges GSP follow-up inspection; City (state), county (district) food and drug administration (market supervision administration) is responsible for daily supervision and GSP follow-up inspection;

2. Drug retail chain enterprises: the municipal (state) Food and Drug Administration is responsible for examination and approval and GSP certification and follow-up inspection, and the county (district) Food and Drug Administration (Market Supervision Administration) is responsible for daily supervision and GSP follow-up inspection;

3. Drug retail enterprises: the municipal (state) food and drug administration is responsible for the examination and approval and GSP certification inspection, and arranges GSP follow-up inspection. The county (district) food and drug administration (market supervision administration) is responsible for the preliminary examination and daily supervision of newly applied drug retail enterprises and GSP follow-up inspection.

Guizhou Food and Drug Administration

March 17, 2015 (Post)