Regulations for Labeling Pharmaceutical Raw Materials and Instruction Leaflets

Regulations for Labeling Pharmaceutical Raw Materials and Instruction Leaflets

1. Drug Label:

• Includes the main label, secondary label, and instruction leaflet.

• Batch Number: Indicated by numbers, letters, or a combination of both.

2. Original Label:

• The label originally attached to the commercial packaging of the pharmaceutical raw material by the manufacturing facility.

3. Font Size:

• Secondary Label: Minimum font height >= 0.9mm.

• Main Label: Minimum font height >= 1.2mm.

4. Label Addition:

• Secondary Label: Deliver the drug to the GSP warehouse for addition.

• Instruction Leaflet: Deliver the drug to the GMP secondary packaging unit for addition or replacement.

5. Packaging Classification:

• Primary Packaging: Packaging in direct contact with the drug (commercial packaging).

• Secondary Packaging: Packaging not in direct contact with the drug.

• Intermediate Packaging: Packaging used to package one or multiple units of a drug with direct packaging, located within the outer packaging of the drug.

6. Prescription Drugs:

• Mark “Rx” in the upper left corner of the drug name on the label.

7. Small Mass/Volume:

• If the mass or volume of the drug is less than 1mg or 1ml, express it as a decimal rounded to two decimal places.

8. Expiration Date Changes:

• The Minister of Health has the authority to change the expiration date of a drug in emergency situations.

9. Imported Drugs:

• Imported drugs that do not fully comply with the labeling requirements may still be allowed clearance.

• Secondary label must be added: Deliver to the GSP warehouse.

• Instruction leaflet must be added: Deliver to the GMP secondary packaging unit.