1.0

Quality Management

1.1

System

1.1.1

Drug retail entities shall, in accordance with relevant laws, regulations, and the requirements of the GSP, develop quality management documents aligned with their actual circumstances. These documents shall cover quality management rules, job responsibilities, operating procedures, archives, records, vouchers, and other relevant aspects.

Records and vouchers related to drugs under special management shall be kept in accordance with relevant provisions (reasonable omission).

1.Drug retail entities shall define the responsibilities of the persons in charge of the entity, quality management, procurement, acceptance checks, sales, prescription review and dispensing, and other positions. 0.5 points will be deducted for non-compliance. [Yearly]

2.Drug retail entities shall establish operational procedures for drug retail, including: (1) Drug procurement, acceptance checks, and sales; (2) Prescription review, dispensing, and verification; (3) Review, dispensing, and verification of prescriptions for TCM decoction pieces; (4) Sale of subpackaged drugs; (5) Sale of drugs under special management and drugs subject to specific national management requirements; (6) Display and inspection of drugs in business premises; (7) Storage of refrigerated drugs in business premises; (8) Operation and management of the computer system; and (9) Operational procedures for storage and maintenance if a warehouse is established. 0.3 points will be deducted for each omission, with a total of 2.7 points deducted for all omissions. [Yearly]

3.Records and vouchers for drugs under special management shall be kept according to relevant provisions. 0.3 points will be deducted for non-compliance. (Reasonable omission) [Yearly]

(Drug retail entities shall upload the relevant documents. The system will automatically assess the items based on the uploaded documents, and points will be deducted for failure to upload the required files. Reasonable omissions will be automatically scored)

3.5

1.1.2

Drug retail entities shall take measures to ensure that all personnel correctly understand and effectively implement the quality management documents. Drug retail entities shall regularly examine and promptly revise the quality management documents.

1. Drug retail entities shall upload their quality management training records. 1 point will be deducted for non-compliance. (Drug retail entities shall upload training records and perform self-assessment. Points will be deducted for failure to upload relevant documents) [Yearly]

2.Drug retail entities shall regularly examine and promptly revise the quality management documents according to their established guidelines, and update the documents in a timely manner in response to amendments in relevant laws and regulations. 0.32 points will be deducted for non-compliance. (Self-assessment by drug retail entities) [Yearly]

1.32

1.3

Documents

1.3.1

The records and relevant vouchers shall be kept for at least five years.

Drug retail entities shall keep the records and relevant vouchers for the required period. 0.4 points will be deducted for non-compliance. (Self-assessment by drug retail entities) [Yearly]

0.4

1.3.2

Drug retail entities shall develop corresponding drug quality management rules. The drug retail quality management rules shall include:

1.Management of drug procurement, acceptance, display, sales processes, etc., and the management of storage and maintenance if a warehouse is established;

2.Examination of suppliers and purchased drug varieties;

3. Management of prescription drugs sales;

4. Management of drug subpackaging;

5. Management of drugs under special control and those subject to special national management requirements;

6. Management of records and vouchers;

7. Management of the collection and inquiry of quality-related information;

8.Management of quality incidents and quality complaints;

9. Management of the review, dispensing, and verification of prescriptions of TCM decoction pieces;

10. Management of drug expiration dates;

11. Management of unqualified drugs and drug disposal; 12. Provisions on workplace hygiene and personnel health;

13. Management of pharmaceutical services, such as drug consultation, guidance on rational drug use, etc.;

14. Provisions on personnel training and assessment;

15. Provisions on reporting adverse drug reactions;

16. Management of the computer system; 17. Provisions on drug traceability;

18. Management of storage and distribution; (Reasonable omission), and

19.Other rules that shall be specified. (Reasonable omission)

Drug retail entities shall develop corresponding quality management rules in compliance with GSP requirements. A deduction of 0.04 points will be applied for each missing provision, and 0.76 points for total non-compliance. [Yearly]

(Drug retail entities shall upload the relevant documents. The system will automatically assess the items based on the uploaded documents, and points will be deducted for failure to upload the required files.

Reasonable omissions will be automatically scored)

0.76

2.2

Training

2.2.1

Employees in all positions within drug retail entities shall undergo pre-service and continuing training on relevant laws, regulations, and professional pharmaceutical knowledge and skills to meet the requirements of the GSP. Drug retail entities shall develop annual training plans, conduct regular training sessions, and maintain training records to ensure that personnel fully understand and correctly perform their duties.

1.Drug retail entities shall develop annual training plans. 0.5 points will be deducted for non-compliance. [Yearly] (Drug retail entities shall upload the relevant documents. The system will automatically assess the items based on the uploaded documents, and points will be deducted for failure to upload the required files.)

2.Drug retail entities shall upload pre-service and continuing training records or complete the training through the System. Registered Macao pharmaceutical technicians shall complete their continuing education as required. 2 points will be deducted for non-compliance. [Yearly] [Records shall be uploaded again for any new personnel] (Drug retail entities shall upload the relevant documents. The system will automatically assess the items based on the uploaded documents, and points will be deducted for failure to upload the required files. Reasonable omissions will be automatically scored)

2.5

2.2.2

Drug retail entities shall provide the necessary support for personnel responsible for selling drugs under special management, drugs subject to specific national management requirements, and refrigerated drugs, to receive appropriate training, ensuring they fully understand relevant laws, regulations, and professional knowledge. (Reasonable omission)

Drug retail entities shall upload relevant training records. 0.58 points will be deducted for non-compliance. [Yearly] [Records shall be re-uploaded in the event of any personnel changes related to the management of relevant drugs.] (Self-assessment by drug retail entities; reasonable omissions will be automatically scored)

0.58

2.3.2

Drug retail entities shall prominently display relevant licenses on their business premises.

The drug distribution license, business license, registration certificates for licensed pharmacists, and recordation certificates for Macao pharmaceutical technicians shall be displayed prominently. 0.5 points will be deducted for non-compliance. (Self-assessment by drug retail entities) [Yearly]

0.5

3.0

Premises

and Equipment

3.1

Premises

3.1.1

The business premises of drug retail entities shall correspond to the scope and scale of their drug distribution, featuring shelves and counters. The premises shall be spacious, bright, clean, sanitary, and separated from storage, office, living assistance areas, and other sections. Appropriate facilities or other effective measures shall be provided to prevent the drugs from being affected by external environmental factors.

0.86 points will be deducted for non-compliance. (Self-assessment by drug retail entities) [Monthly]

0.86

3.1.2

If a warehouse is set up, drug retail entities shall ensure that the interior walls and ceilings are smooth, the floor is flat, and the doors and windows are securely structured. Reliable security and theft prevention measures shall also be in place.

A dedicated warehouse shall be set up for the storage of TCM decoction pieces. (Reasonable omission)

1.12 points will be deducted for non-compliance. (Self-assessment by drug retail entities; reasonable omissions will be automatically scored) [Monthly]

1.12

3.2

Equipment

3.2.1

Drug retail entities shall, in accordance with the relevant national regulations, regularly calibrate or verify measuring instruments, and temperature and humidity monitoring equipment. Calibration or verification shall be conducted at least once a year, with a certificate of compliance issued. Relevant equipment includes but is not limited to the following:

1.Thermometer

2.Hygrometer

3.Measuring instruments (no standards for measuring TCM decoction pieces; reasonable omission)

The calibration or verification certificates for measuring instruments and temperature and humidity monitoring equipment shall be uploaded. 1.72 points will be deducted for non-compliance. (Drug retail entities shall upload the relevant documents. The system will automatically assess the items based on the uploaded documents, and points will be deducted for failure to upload the required files.

Reasonable omissions will be automatically scored) [Yearly]

1.72

3.2.2

The business premises of drug retail entities shall maintain specialized equipment appropriate for the scope of their drug distribution.

1.Equipment for monitoring and regulating temperature;

2.Equipment for storing TCM decoction pieces and dispensing prescribed ingredients if engaged in the distribution of TCM decoction pieces; (Reasonable omission)

3.Specialized refrigeration equipment if engaged in the distribution of refrigerated drugs; (Reasonable omission)

4.Specialized storage equipment meeting safety regulations if engaged in the distribution of psychotropic drugs of category II, toxic varieties of traditional Chinese medicines, and poppy capsules; (Reasonable omission)

5.Dispensing tools and packaging materials necessary for the subpackaging of drugs for sale; and (Reasonable omission)

6.Storage facilities in compliance with national regulations if engaged in the distribution of drugs under special management. (Reasonable omission)

For the first, second, fourth, fifth, and sixth items, 0.58 points will be deducted for non-compliance; for the third item, 0.65 points will be deducted for non-compliance; and 3.55 points will be deducted for total non-compliance. (Self-assessment by drug retail entities) [Yearly]

3.55

4.0

Procurement and Acceptance Check

4.1

Procurement

4.1.1

The procurement of drug retail entities shall comply with laws and regulations, and the necessary documents, records, archives, and other materials shall be provided in accordance with the requirements of *12304, *12305, *15201, 15202, 15203, *15204, *15205, 15206, *15207, and 15208 of the GSP.

There are 4 general items, with 0.58 points deducted for each omission; and 6 major items (*), with 0.62 points deducted for each omission, for a total of 5.88 points. (Self-assessment by drug retail entities) [Yearly]

6.04

4.1.2

The procurement of drug retail entities shall comply with laws and regulations and provide invoices as required by **15209, 15210, **15211, 15212, 15213, and *15301 of the GSP, ensuring consistency among invoices, accounting records, and goods.

There are 3 general items, with 0.58 points deducted for each omission; 1 major item (*), with 0.62 points deducted for omission; and 2 critical items (**), with 0.72 points deducted for each omission. 3.76 points will be deducted for total non-compliance. (Self-assessment by drug retail entities) [Monthly]

3.8

4.2

Acceptance Check

4.2.1

Drug retail entities shall conduct acceptance checks for drugs in accordance with the requirements of *12306, *15401, 15402, 15403 (reasonable omission), 15404, 15405, 15406, *15501 (reasonable omission), 15601, 15602, *15701 (reasonable omission), 15801, and 15802 of the GSP.

There are 9 general items, with 0.58 points deducted for each omission; and 4 major items (*), with 0.62 points deducted for each omission. 7.7 points will be deducted for total non-compliance. (Self-assessment by drug retail entities) [Monthly]

7.7

5.0

Display, Maintenance, and Storage

5.1

Environmental Requirements for Drug Display

5.1.1

Temperature and humidity monitoring records shall be submitted at least once in the morning and once in the afternoon daily. The humidity (35%-75%) and temperature for drug storage shall be categorized into the following three conditions:

1.Normal-temperature warehouse (10-30℃);

2.Cool warehouse (below 20℃); and

3.Refrigerated drugs stored at the labeled temperature. (Reasonable defect)

Drug retail entities shall submit the temperature and humidity records while meeting the corresponding requirements. 1.45 points will be deducted for each missed entry in the morning or afternoon, up to a total of 2.9 points. [Daily] (The temperature and humidity records submitted by drug retail entities will be automatically scored for compliance)

2.9

5.1.2

Drug retail entities shall regularly conduct sanitary inspections of their business premises to ensure a clean environment, proper display of drugs, and the absence of items unrelated to business activities, in accordance with the requirements of *13201, 16001, 16002, *16101, 16102, 16103, 16104, *16105, *16106, *16107, 16108 (reasonable omission), 16109 (reasonable omission), 16112 (reasonable omission), and *16116 of the GSP.

There are 8 general items, with 0.58 points deducted for each omission; and 6 major items (*), with 0.62 points deducted for each omission, up to a total of 8.36 points. (Self-assessment by drug retail entities) [Monthly]

8.36

5.3

Storage Warehouse

5.3.1

If a warehouse is set up, drug retail entities shall manage the warehouse and the drugs within it in accordance with the requirements of 16401, 16404, 16405, 16406, *16407, *16408, *16409, *16410, *16411, *16412, 16413, 16414, 16415, 16416, 16417, 16418, *16419, 16420, 16421, *16422, and 16423 of the GSP.

(Reasonable omissions)

There are 13 general items, with 0.58 points deducted for each omission; and 8 major items (*), with 0.6 points deducted for each omission, up to a total of 5.8 points. (Self-assessment by drug retail entities) [Monthly]

12.34

6.0

Sales Management

6.1

Prescription Drugs and Over-the-

Counter (OTC) Drugs

6.1.1

Prescription drugs may only be dispensed after review by licensed pharmacists; drugs listed in the prescription shall not be modified or substituted without authorization. Pharmacists shall refuse to dispense prescriptions with drug incompatibilities or excessive dosages unless corrected or re-signed by the prescribing physician. The personnel responsible for prescription review, dispensing, and verification shall sign or stamp the prescription, and retain the original prescription or its photocopy in accordance with relevant regulations.

1.Prescription drugs shall be reviewed and dispensed by licensed pharmacists, with proper recording and retention of prescriptions according to the Notice on Further Strengthening the Supervision and Administration of Prescription Drug Sales by Drug Retail Enterprises. 1.24 points will be deducted for non-compliance. [Weekly]

2.Personnel responsible for reviewing, dispensing, and verifying prescriptions shall sign or stamp both the registration forms and the prescriptions. 0.58 points will be deducted for non-compliance. (Self-assessment by drug retail entities) [Weekly]

(Prescription drug sales records shall be registered in the System and prescriptions photographed for retention. The items will be automatically scored when the corresponding records are uploaded. Reasonable omissions will be automatically scored.)

1.82

6.1.2

1. Drug retail entities shall issue sales vouchers and maintain sales records for drug sales;

2. Drug retail entities shall inform customers of the expiry date when selling drugs nearing their expiration; and

3. Drug retail entities shall ensure accurate measurement of TCM decoction pieces and provide customers with instructions on decoction methods and relevant precautions. (Reasonable defect)

For the first item, 1.16 points will be deducted for non-compliance. For the second item, 0.58 points will be deducted for non-compliance. For the third item, 0.58 points will be deducted for non-compliance. 2.32 points will be deducted for total non-compliance. (Self-assessment by drug retail entities) [Monthly]

2.32

6.2

Subpackaged Drugs

6.2.1

The sale of subpackaged drugs shall comply with the requirements of 16901, 16902, *16903, 16904, 16905, and 16906 of the GSP.

(Reasonable omission)

There are 5 general items, with 0.58 points deducted for each omission; and 1 major item (*), with 0.62 points deducted for omission, up to a total of 3.52 points. (Self-assessment by drug retail entities; reasonable omissions will be automatically scored) [Monthly]

3.52

6.4

Drug Advertisement

6.4.1

Drug advertisements shall strictly comply with the relevant national regulations on advertising management.

0.5 points will be deducted for non-compliance. (Self-assessment by drug retail entities) [Yearly]

0.5

6.5

Decoction Services for Traditional Chinese Medicine

6.5.1

The provision of decoction services for TCM decoction pieces shall comply with the relevant national regulations. (Reasonable omission)

The requirements for personnel, equipment, decoction procedures, and management rules shall be met as per the Notice on Issuing the Management Guidelines for Decoction Rooms of Traditional Chinese Medicine in Medical Institutions. 0.5 points will be deducted for non-compliance. (Self-assessment by drug retail entities; reasonable omissions will be automatically scored) [Yearly]

0.5

6.6

Online Sales

6.6.1

Drug retail entities shall report information, including the enterprise name, website name, application name, IP address, domain name, and drug distribution license, to the Commercial Services Bureau of the Cooperation Zone.

Drug retail entities shall report information including the website name, application name, IP address, domain name, and drug distribution license. 1 point will be deducted for non-compliance. (Reasonable omission) [Yearly]

1

6.6.2

Online drug retail entities shall adhere to the following requirements:

1. Online drug retail entities shall enter into agreements with electronic prescription providers, and examine and dispense prescriptions in strict accordance with relevant regulations. Used electronic prescriptions shall be marked to prevent repeated use.

2. The drug distribution license shall be continuously and prominently displayed on the homepage or the main page of business activities.

3. Prescription drugs and OTC drugs shall be displayed separately, with clear labels on relevant webpages. Risk warning information, such as “Prescription drugs must be purchased and used under the guidance of a pharmacist,” shall be highlighted on each drug display page.

4. The main and home pages for prescription drug sales shall not directly display packaging, labels, or any other prescription drug-related information. Before the prescription is reviewed, drug instructions and related purchasing services shall not be displayed or provided.

5. For the sale of drugs to individuals, sales vouchers shall be issued in accordance with relevant regulations. Online drug retail entities selling prescription drugs shall also retain records of prescriptions and online pharmaceutical services for at least five years, and not less than one year after the drug’s expiration date.

6. Online drug retail entities shall be responsible for the quality and safety of drug deliveries.

7. Online drug retail entities shall display information regarding the qualification certificates of legally staffed pharmacists and other pharmaceutical technicians.

8. Registered Macao pharmaceutical technicians working in drug retail entities in the Cooperation Zone and engaging in online sales or prescription reviews shall follow relevant normative documents.

There are 8 items, with 0.5 points deducted for each omission, up to a total of 4 points. (Self-assessment by drug retail entities; reasonable omissions) [Monthly]

4

7.1.2

1.Drugs shall not be returned or exchanged once sold, except in cases of quality issues; 2. Drug retail entities shall display the supervision hotline of the drug regulatory department at their business premises, maintain a customer feedback book, and promptly address customer complaints regarding drug quality; and 3.The quality management department or personnel shall be responsible for handling drug quality complaints and investigating, addressing, and reporting quality-related incidents.

0.5 points for each item. Drug retail entities shall upload relevant records. 1.5 points will be deducted for total non-compliance. (Self-assessment by drug retail entities) [Yearly]

1.5

7.1.3

If any sold drugs are found to have serious quality issues, drug retail entities shall take immediate measures to recover the drugs, maintain records, and report the issue to the drug regulatory department. Drug retail entities shall assist drug manufacturers in fulfilling their recall obligations by controlling and recovering drugs with safety risks, and shall establish drug recall records. (Reasonable omission)

Drug retail entities shall upload records of drug recovery and recall. 1 point will be deducted for non-compliance. (Self-assessment by drug retail entities; reasonable omissions will be automatically scored) [Yearly]

1

7.2

Adverse Reactions

7.2.1

Drug retail entities shall collect and report information on adverse drug reactions in accordance with the relevant national regulations on the adverse drug reaction reporting system. (Reasonable omission)

Drug retail entities shall upload records of adverse reactions. 1 point will be deducted for non-compliance. (Self-assessment by drug retail entities; reasonable omissions will be automatically scored) [Monthly]

1

8.0

Sales of Designated Drugs (reasonable defect)

8.1

Quality Management Requirements

8.1.1

Designated drug retail entities shall possess the business qualifications to sell designated drugs and employ Macao technicians registered with the drug regulatory department of the Cooperation Zone. The management of drug procurement, acceptance checks, display, and sales shall be conducted in accordance with relevant requirements.

1 point will be deducted for non-compliance. (Self-assessment by drug retail entities; reasonable omissions will be automatically scored) [Monthly]

2

8.1.2

Designated drug retail entities shall legally and compliantly procure drugs from designated wholesale enterprises in accordance with the designated drug list, ensuring consistency among invoices, accounting records, and goods.

2 points will be deducted for non-compliance. (Self-assessment by drug retail entities; reasonable omissions will be automatically scored) [Monthly]

1

8.1.3

Designated drug retail entities shall set up separate sales counters and categorize the displayed drugs based on dosage forms, purposes, and storage requirements.

1 point will be deducted for non-compliance. (Self-assessment by drug retail entities; reasonable omissions will be automatically scored) [Monthly]

1

8.1.4

Designated drug retail entities shall adopt IT-based recording measures for the sale of designated drugs in accordance with the requirements of the drug regulatory department of the Cooperation Zone, so as to ensure drug traceability.

Drug retail entities shall upload relevant sales information. 2 points will be deducted for non-compliance. (Self-assessment by drug retail entities; reasonable omissions will be automatically scored) [Monthly]

2

Total

100

9.0

Deduction Item

9.1

Pharmacy Management

9.1.1

Employee(s) engage in actions that compromise the quality and safety of drugs within their work area.

1 point will be deducted for each occurrence identified during on-site inspections by supervisory personnel.

9.1.2

Drug retail entities shall establish relevant records for drug procurement, acceptance checks, sales, display inspections, temperature and humidity monitoring, and the disposal of unqualified drugs, ensuring that the records are true, complete, accurate, effective, and traceable.

0.5 points will be deducted for each omission of the relevant records.

9.1.3

Drug retail entities shall operate in accordance with the law and in an honest and trustworthy way. Any fraudulent or deceptive activities is prohibited.

5 points will be deducted for the intentional uploading of false information.

9.2

Sales of Prescription Drugs

9.2.1

Prescription drugs or Class A OTC drugs are sold without a licensed pharmacist on duty.

2 points will be deducted for each occurrence identified during on-site inspections by supervisory personnel.

9.2.2

Drug retail entities sell prescription drugs but do not retain or register prescriptions as required by the Notice on Further Strengthening the Supervision and Administration of Prescription Drug Sales by Drug Retail Enterprises.

1 point will be deducted for each occurrence identified during on-site inspections by supervisory personnel.

9.3

Administra-

tive Penalty

9.3.1

Drug retail entities violate drug safety laws and regulations, resulting in administrative penalties such as fines, confiscation of illegal proceeds (illegal property), or orders to cease production or business (except as exempted from other administrative penalties under Article 75 of the Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China); or cause adverse social impact through violations of drug safety laws and regulations;

5 points will be deducted for each occurrence.

9.3.2

Drug retail entities are involved in drug safety incidents.

5 points will be deducted for each occurrence.

9.3.3

The results of drug supervision and random inspections fail to meet drug safety standards.

1 point will be deducted for each unqualified batch.

9.3.4

Drug retail entities refuse, evade, or obstruct law enforcement personnel in supervision and inspection, refuse to cooperate with law enforcement in case investigations, or do not rectify identified violations within the prescribed time limit.

2 points will be deducted for each occurrence.

10.0

Bonus Item

10.1

Public Pharmaceu-tical Services

10.1.1

Drug retail entities file the business hours and the working hours of licensed pharmacists in the System daily, and display the business hours at the entrance.

2 points will be awarded for daily compliance with the filing in the System and public display of the relevant information outside the premises. (Self-assessment by drug retail entities)

10.2

Other Bonus Conditions

10.2.1

Drug retail entities are commended or awarded by the people’s government at or above the prefecture or municipal level.

5 points will be awarded for compliance.

10.2.2

Other circumstances where the risk grade may be lowered in accordance with laws, regulations, rules, and the provisions of provincial regulatory departments.

5 points will be awarded for compliance.