DISTRIBUTION AND MARKETING OF DRUGS IN VIETNAM | OVERVIEW DOANH TRI LAW FIRM

Medicine is a special commodity, directly related to the health and life of everyone. The State currently has strict regulations on drug import and distribution activities. In this article, Doanh Tri Law Firm will provide an overview of the distribution and marketing of drugs in Vietnam.

I. Legal basis

- Law on Pharmacy 2016;

- Law on Commerce 2005;

- Law on Advertising 2012

- Decree No. 81/2018/ND-CP of the Government dated 22 May 2018 elaborating on provisions of the Commercial Law on trade promotion (Decree 81);

- Decree No. 54/2017/ND-CP of the Government dated 9 May 2017 guiding the implementation of the Law on Pharmacy (Decree 54).

II. Distribution

1. Condition for distribution

Authorization

To be distributed in Vietnam, a drug must have a marketing authorization (MA) number issued by the Drug Administration of Vietnam (DAV) under the Ministry of Health (MOH). Pursuant to the Law on Pharmacy 2016, an MA number for a drug should be issued within 12 months of the receipt of a complete application dossier. In practice, the timeline for issuance of an MA number for a drug can range from 12 to 30 months. Drugs granted MA numbers can be imported into Vietnam without an import license.

Drugs used for certain special purposes can be imported into and distributed in Vietnam without MA numbers if they are granted import licenses. The exceptions include:

- Finished Drug products containing active ingredients (without MA numbers) specified in the guidelines for disease diagnosis, prevention, and treatment promulgated and approved by the Ministry of Health; used for emergency, poison control, and anti-rejection purposes; or used for diagnosis, prevention, or treatment of class-A communicable diseases, cancer, HIV/AIDS, hepatitis, tuberculosis, malaria, and other diseases announced by the Minister of Health.

- Finished drug products containing active ingredients (with MA numbers) which are in insufficient supply for treatment demands.

- Finished drug products containing herbal ingredients (previously used medicinally in Vietnam, or being used medicinally in Vietnam for the first time) which are in insufficient supply for treatment demands.

- Drugs with:

+ Have the similar trade name, active ingredients, concentration and dosage form as an original brand name drug that is granted a certificate of free sale in Vietnam;

+ Similar manufacturer as the original brand name drug or an authorized manufacturer;

+ Lower price than that of the original brand name drug being sold in Vietnam, at the request of the Minister of Health.

- Drugs for aid or humanitarian aid;

- Drugs used for health programs of Vietnam

- Drugs used for clinical trials, bioequivalence studies, bioavailability assessments, as samples for registration, testing, or scientific research, or for display at fairs or exhibitions;

- Drugs used for other non-commercial purposes.

There are some special cases that drugs can be accessed before being granted MA, as following:

- Finished Drug products containing active ingredients (without MA numbers) specified in the guidelines for disease diagnosis, prevention, and treatment promulgated and approved by the Ministry of Health; used for emergency, poison control, and anti-rejection purposes; or used for diagnosis, prevention, or treatment of class-A communicable diseases, cancer, HIV/AIDS, hepatitis, tuberculosis, malaria, and other diseases announced by the Minister of Health;

- Finished drug products containing active ingredients (with marketing authorization (MA) numbers) which are in insufficient supply for treatment demands;

- Drugs used for special treatment.

However, there is no specific definition of which cases will be considered to be in "insufficient supply for treatment demands" or "used for special treatment demands". This depends on the evaluation of the DAV.

Requirment to import

- The drugs must be permitted to be circulated in the manufacturing country, a member country of ICH, or Australia.

- The drugs must have clinical data on safety and efficiency if they are not entitled to exemption from clinical trials under the regulations of the Ministry of Health. This requirement is applicable only to the first submission unless there are any changes to the indication, dosage, and target users.

+ For rare drugs, the importation must be requested by medical facilities.

+ For drugs for special treatment, the drugs must be permitted to be circulated in at least one country in the world.

2. Licensing

Dossiers of application:

The dossier is required to comply with the ASEAN/ICH Common Technical Dossier (ACTD/ICH-CTD) requirements for the registration of pharmaceuticals for human use. In particular, an application dossier for a new drug or biological product registration should include the following parts:

Part I. Administrative data and product information dossier;

Part II. Quality dossier;

Part III. Preclinical dossier; and

Part IV. Clinical dossier.

Regulatory authority

The DAV under the Ministry of Health is responsible for the issuance of MA numbers and the licensing procedure in Vietnam.

3. Distribution

Drugs for distribution in Vietnam are divided into two categories: prescription drugs and non-prescription drugs.

Authorized subject to distribute drugs:

- Drugstores.

- Dispensaries.

- Drug cabinets of commune health stations.

- Retailers of herbal ingredients, herbal drugs and traditional medicines.

In order to lawfully distribute drugs to consumers, a drug retail establishment in one of the above first three categories must obtain a Good Pharmacy Practice (GPP) Certificate from the provincial Department of Health in which the retailing establishment is located. It must satisfy certain conditions on personnel and infrastructure set out by the Ministry of Health (MOH). Specifically, the owner and/or the person in charge of professional matters must have a Pharmaceutical Practice Certificate; while the seller must have professional certificates in the pharmaceutical domain and a training period suitable for the assigned tasks.

The application dossier for the Certificate of Eligibility for Pharmaceutical Business (CEPB) is the basis to grant a GPP Certificate, in which the technical document for retailers includes:

- Human resources organizational chart, list of personnel, names, titles and professional qualifications.

- Floor plans of the retail establishments.

- List of equipment (including information on computer systems and network management software).

- List of regulations, files, documents, and standard operating procedures (SOPs).

- GPP self-checklist (a standard form set out by the Vietnamese Government).

If the drug retail establishment requests the competent authority to grant a GPP certificate together with a CEPB, the retailer must clearly state this request in the application form for the CEPB.

Drug prescription authorities

- Doctors in possession of a valid practicing certificate, who have registered to practice at a legal medical examination and treatment establishment in accordance with the regulations of the Law on Medical Examination and Treatment.

- Medical assistants in possession of a valid practicing certificate, who have registered to practice at level 4 (ward and commune level) health facilities.

III. Marketing

1. Marketing activities of drugs include:

- Promotion.

- Advertising.

- Drug introduction seminars.

- Dissemination of drug information material to healthcare professionals.

- Trade fairs and exhibitions.

For the promotion of drugs, it is prohibited to promote any drugs used for human treatment (such as: giving free samples), except for promotion among drug traders/distributors. The promotion of drugs to end-users or health professionals is strictly prohibited.

2. It is prohibited to advertise to consumers:

- Drugs without a valid marketing authorization (MA) number in Vietnam.

- Prescription drugs.

- Vaccines or medical-biological products used for disease prevention.

- Non-prescription drugs whose use should be restricted or should be supervised by a doctor, as recommended in writing by the competent state administrative body.

3. The advertising of drugs can be in the following forms:

- Advertisements in books, newspapers, magazines, leaflets, and posters.

- Advertisements on billboards, placards, panels, banners, objects which are illuminated or appear in the air or underwater, means of transportation, and other mobile objects.

- Advertisements on radio and television.

- Advertisements in electronic newspapers, company websites, and websites of advertising service providers.

- Advertisements on other means of advertising as permitted by law.

The above information is about the ‘Conditions for importing drugs into Vietnam.' For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

Hotline: (+84) 911.233.955 - (024) 6293 8326

Email: [email protected]

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