Macau pharmacy license acquisition process and general requirements
Macau is a world-famous tourism and gaming city, with more than 30 million business travelers entering Macau every year. Macau itself is an international free port like Hong Kong. Taxes are quite favorable. The retail price of its medicines is quite different from that of Mainland China. Investment in pharmaceutical business is undoubtedly a good cause.
According to the Decree No. 58/90 / M of Macau on September 19, anyone who intends to open a pharmacy must apply to the Macau Health Bureau and obtain a pre-licensing license, or surrender the license to the current licensee. The applicant can apply in person or entrust others (such as authorizing the agent of Jin Lei International Co., Ltd.).
I. Applying for a pharmacy license depends on the general requirements
a. The applicant lives or sets up in Macau, or a legal entity established in Macau;
b The applicant or his supervisors, administrative staff or mentors are all engaged in the provision of medical services, especially doctors and related occupations;
c. Applicants and supervisors, administrative staff or facilitators (if legal persons) have appropriate civil qualifications (medical licenses) to engage in drug activities;
d Ensure technical guidance for pharmacies according to law;
f The employees who will work in the pharmacy have the requirements required by law to perform relevant duties;
g The pharmacy's facilities and equipment have the appropriate conditions within the meaning of laws and other laws on the safety, cleanliness and hygiene of commercial premises.
Application procedures and required documents for pharmacy
a completed FA-1 'Pharmacy' license application form;
b. The original of the applicant's personal identity card or the business registration certificate of the legal person enterprise;
c Related documents for legal person managers, administrators or leaders:
d. Macao Resident Identity Card, original passport or certified copy;
f Original Criminal Discipline Certificate issued by the Identification Bureau;
g statement of non-conflict (1);
h Relevant documents for the pharmacy technical supervisor;
i Photocopy of registered pharmacist of Health Bureau, statement of responsibility (1), statement of non-conflict (2);
J. Authentication of identification documents of other employees in the pharmacy;
k Design plan of pharmacy, the place must have at least the following partitions, furniture and equipment (including pharmacy or public reception room, drug storage warehouse and freezer, administrative office, toilet, laboratory, furniture and public reception room or drug Storage warehouse, etc.);
l Use permit issued by the Land, Public Works and Transport Bureau or house inspection paper issued by the Property Registration Bureau;
M Photocopy of the Business Tax Return of the Finance Bureau M / 1;
N Declaration of pharmacy business hours and technical staff working hours;
3. Validation period and official fees for applying for pharmacy opening
The Macao Health Bureau has completed the application approval within 90 days from the date of receipt of the complete application documents. If the approval is passed, a permit for setting up the place will be issued to the applicant. As for the time for issuing the permit, it depends on the applicant's progress in setting up the venue and the legal inspection procedures.
The permit will be issued within 35 working days from the date when the applicant submits complete documents and the application site passes the field inspection. The fee is MOP2,000.
The validity period of the license is one year. The related party can bring the original license with the relevant license before the expiry of the license validity or in December each year, and apply for renewal to the Office of Drug Affairs and pay the renewal fee.
Fourth, the general process of pharmacy ownership transfer
a. According to the current laws and regulations of Macao, if the transfer of ownership of a pharmacy is not a pharmacist or a member of the company to be obtained does not have a pharmacist, the transfer of the pharmacy can only be carried out with the technical guidance of the pharmacy;
b. You need to obtain the 'Declaration of Eligibility for Transfer of Pharmacy Ownership' issued by the Health Bureau before you can sign a concession contract or contract to transfer the ownership of a pharmacy, its operation or the shares of a company owned by a pharmacy;
c. The acquirer or assignee of the pharmacy operation must apply to the Health Bureau for registration of the act within 30 days of the acquisition or assignment, and complete and complete the FA-4 'Pharmacy' ownership transfer registration application form. Handle the application (if the new proprietor is a legal person, the relevant declaration is signed by a member of the government administration who effectively represents the company; if the new proprietor is a legal person, submit the original criminal certificate of the legal person's manager, administrator or leader), together with The documents required for the application are sent by registered mail or directly to the Office of Drug Affairs of the Health Bureau;
d. The time limit for examination and approval shall be completed within 90 days from the date when the Macao Health Bureau receives the complete application documents.
V. What is the difference between Macau pharmacy and drugstore licenses?
According to regulations, a pharmacy refers to a company that dispenses drugs according to a prescription and sells or gives any kind of drugs or substances to the public. A pharmacy refers to a company that can only provide those drugs that are freely sold by the public within the scope of pharmaceutical industry activities. Simply put, pharmacies can dispense prescription drugs to patients based on doctors, while pharmacies can only sell over-the-counter drugs.
What products are available for sale in pharmacies
According to the Macau Law, in addition to drugs and drug substances, pharmacies can also sell the following products:
1. Materials for bandaging and controlling or diagnostic testing;
2. Surgical materials;
3. General prosthetic items;
4. Nutrition products;
5. Personal hygiene products;
6. Medical mineral water;
7. Perfume and makeup items;
8. Phytopharmaceutical products.