What are New Regulations for Pharmaceutical Product Labelling in Vietnam

Author: Kishor Hande

Introduction:-

Vietnam’s Ministry of Health (MoH) issued Circular No. 01/2018/TT-BYT (Circular 01) on January 18, 2018, regarding regulations on labelling of pharmaceutical products. The Circular 01 will replace current regulation Circular No. 06/2016/TT-BYT (Circular 06) and will be in effect from June 1, 2018.

The recent Circular includes guidelines regarding:-

  • Labels of finished product drugs and drug raw materials;
  • Package inserts of finished drugs; and
  • Change in the shelf life indicated on the label of finished drugs in certain cases.

What is Label?

v LABEL:-

"Label means a display of written, printed or graphic matter upon immediate container or the wrapper of a drug package"

TYPES OF LABEL:-

  1. Manufacturer label
  2. Dispensing label

Manufacturer label

A label which contain drug information for the use of medical practitioners, pharmacists, or nurses supplied by the manufacturer, packer, or distributor of the drug (FDA)

LEGAL REQUIRMENTS OF A MANUFACTURER LABEL:-

  1. The name of preparation
  2. Strength and dosage form.
  3. Quantity.
  4. Instructions for the use.
  5. Precautions & warnings.
  6. Registration number.
  7. Batch number.
  8. Manufacturing & Expiry date.
  9. Price
  10. The name and address of pharmaceutical industry

NAME OF THE PREPARATION:-

  • Generic name:

According to drug labelling and packaging rules 1986: "International non-proprietary name means the name of a drug as recommended by WHO or may be notified by the federal govt. in the official gazette"

  • Brand Name:
    • Brand name which is used to market the drug
    • Property of Drug Company
    SPECIFICATION:-
    • U.S.P (United states pharmacopoeia)
    • B.P (British Pharmacopoeia)
    Requirements for Package Inserts of Finished Drugs

    Under current regulations, the package insert (PI) must include two separate sections, one with information for patients and the other with information for healthcare professionals. Under the new regulations, the PI will include only one section, containing general information for both patients and healthcare professionals. The simpler PI will reduce the time spent preparing the language for the PI and preparing packaging samples when registering drugs.

    Finished drugs packaged inserts

    Package insert contains detailed drug information compiled and distributed by the drug manufacturer. Its purpose is to provide complete prescribing and safety information to health professionals. As of now, the package insert (PI) includes two separate sections, each with information for healthcare professionals and patients

    Package Insert Replacement after Finished Drug Is Imported into Vietnam

    Under current regulations, a PI may not be replaced or supplemented after the finished drug is imported into Vietnam. Under the new Circular, this restriction is loosened, and a PI can be replaced or supplemented in Vietnam in the following circumstances:

    • When imported drugs with Marketing Authorization (MA) licenses have Vietnamese-language PIs in their packages but the PIs have not been updated per the MoH’s requirements; and
    • When imported drugs with import licenses do not have Vietnamese-language PIs in their packages.

    Entities in Charge of Imported Drug Labelling:-

    The responsible entities for drug labelling have been changed under the new circular, effectively releasing offshore manufacturers from labelling responsibility.

    • The responsible entities for a product with an MA license will be the importer and the MA holder. Currently, the responsible entities are the manufacturer and the MA holder.
    • The responsible entity for a product with an import license will be the importer only. Currently, the responsible entities are the manufacturer and the importer.
    • 1.: Applied to drugs with single content
    • 2.: Must be written: "Inform doctors about unexpected reactions after using drugs"
    • 3.: The drugs that belongs to prescription list must be written: "Drug sold by prescription", and marked Rx on the left top corner; the eye drop must be written: "Eye drop"; the nose drop must be written: "Nose drop"
    • 4. Package inserts must be written: "This drug is administered according to doctors’ prescription"
    • 5. Remarkable note: "Keep out of reach of children"; "Read carefully the package insert before use"
    • 6. for injectable drugs, route of administration must be stated intramuscular injection, subcutaneous injection or intravenous injection; the orally administered drug bottle must be written "No injection"
    • 7. Shelf-life of drugs must be state.

    Other requirements

    Vials, ampoules and blister / strips must be contained in labelled box according to regulations. - For Parameter No. 5, 6 and 7, if the box is too small to mention those parameters, the sentence "Please read the package insert" must be written. - Imported drugs must state name of the manufacturing country. - Expiry date must be written by 2 numbers of a month and 2 numbers of a year (For example, 20/03/06). - Package insert must be written in Vietnamese.

    Label Review

    With the shift in responsibility of drug labelling, Importer and MA holder should get their Label reviewed from a Regulatory Affair expert or a life science graduate who has experience and has completed DRUG REGULATORY AFFAIRS Courses.

    REFERENCES:-

    1. Mannual of drug laws 2014
    2. Dispensing for pharmaceutical students pharmacy

    By S.J Carter

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