How to Apply
Time of application: Before applying for the import licence for diagnostic and laboratory reagents, the applicant must first obtain the relevant prior authorisation for import from the Pharmaceutical Administration Bureau.
Eligibility: Businesses holding the “Registration for Controlled Foreign Trade Operations” issued by the Economic and Technological Development Bureau.
Application procedures and documents required:
In order for the diagnostic and laboratory reagents to be authorised for import, the following documents and information must be submitted in advance:
- Product information or package insert of the reagents, which should include the name of product, active ingredient contents, storage conditions, brand name, etc, as well as quality documents if required;
- A relevant “prior authorisation[doc][pdf]” must be completed for each import application.
Location of Application and Service Hours
Location of application: Pharmaceutical Administration Bureau
Address: Avenida do Comendador Ho Yin, Edifício de Escritórios do Governo (Qingmao), 19.º andar, Macau
Service hours:
Mondays to Thursdays: 09:00-13:00; 14:30-17:45
Fridays: 09:00-13:00; 14:30-17:30
Closed on Saturdays, Sundays and public holidays
Fees
Free of charge
Application Processing Time
The prior authorisation will be issued in 3 working days upon receipt of all required documents. (Performance Pledge)
Remarks/ Notes to Application
- If the reagent is a reference standard containing highly toxic pesticides, such as Aldicarb, Toxaphene, Chlorodan(e), Heptachlor, Chlodimeform, DBCP(Dibromochloropropane), DDT, Aldrin, Dieldrin, Endrin, EDB (Ethylene Dibromide), HCH, Lindane, Paraquat, Parathion, Methyl Parathion, Pentachlorophenol and 2,4,5-T, the importer should submit the original letter of statement from the user to declare its purpose, dosage and that the reagent is not for sale.
- If the reagent is a reference standard containing non-toxic pesticides, the importer should state the name of the end user of the product, as well as its purpose and dosage, on the Remarks of the Prior Authorisation for Import of Diagnostic and Laboratory Reagents.
- If the products to be imported contain dangerous substances, the UN number or CAS number of the said substances must be provided under the product name column of the Prior Authorisation form.
Relevant Specifications or Requirements
Law no. 7/2003 – Foreign Trade Law
Law no. 12/2022 – Legal regime for the control of dangerous substances
Administrative Regulation no. 27/2023 – Main regulation of the legal regime for the control of dangerous substances
Chief Executive Dispatch no. 209/2021 – List of Goods Authorised for Importation
Chief Executive Dispatch no. 107/2023 – Defines the subcategorization and enumeration of hazardous substances
Application Status Enquiry and Result Collection
Method of result collection: In person