Marketing, Manufacturing, Packaging & Labeling, Advertising
The key facts about marketing, manufacturing, packaging & labeling, advertising in Vietnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for USD 99.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
Under Vietnamese law, pharmaceutical products or drugs are defined to cover all modern drugs, herbal drugs, traditional drugs, vaccines, and biologicals.
In general, a pharmaceutical product circulating on the market must have an MA or drug registration number, which is issued by the DAV.
The MA applicant must submit an application dossier (new registration) to the DAV. Within 12 months from the date of receiving a complete and valid application, the DAV will grant the MA. If the DAV considers the application dossier to be inadequate or incomplete, it will issue an official letter clearly stating the supplementary requirements necessary or the reason for refusal. In practice, the timeline for obtaining an MA can be prolonged from 12 to 36 months.
By law, to be circulated in Vietnam, all medical devices must be granted a valid MA number or import license.
The MA number for Class A (lowest-risk) medical devices is simply the number of a receipt note from the DOH of the province where the registrant is located, acknowledging that a dossier on declaration of applicable standards has been submitted. The DOH will give the dossier a preliminary evaluation and grant a receipt note within three working days.
The MA number for Class B, C and D (higher-risk) medical devices is found on an MA license, the application dossier for which must be submitted to the DMEC, which will review the dossier and grant the MA license within 60 days from the submission date of the complete dossier. In practice, however, the DMEC does not yet have the capacity to evaluate these dossiers in a timely manner. Thus, MA licenses have only been granted to Class B, C, and D medical devices that are domestically manufactured, while imported devices will not be required to have MA licenses until January 1, 2022.
Instead, in the transition period, Class B, C, and D medical devices which are specifically listed in Circular 30/2015/TT-BYT on Import of Medical Devices (Circular 30) must have a valid import license to be imported into Vietnam, and this import license serves as the MA number. Class B, C and D medical devices that are not specifically listed in Circular 30 can be freely imported into, and circulated in, Vietnam without any import license, provided that their certificates of classification results are published on the MOH website (http://dmec.moh.gov.vn).
2. What is the authorization process for the marketing of generic versions of these products?
Please see question 1 (above).
3. What are the typical fees for marketing approval?
Please see question 4 of Regulatory, Pricing and Reimbursement Overview.
4. What is the period of authorization and the renewal process?
Please see question 5 of Regulatory, Pricing and Reimbursement Overview.
5. What are the requirements, if any, for post-approval pharmacovigilance?
The MA holder, after obtaining the MA, is obligated to comply with the quality and safety requirements registered in the MA dossier.
If drugs with valid MAs for circulation in Vietnam have had their registration numbers revoked in any country in the world, the MA holders must notify the DAV and relevant authorities. Similarly, MA holders have the responsibility to report any adverse reactions from registered drugs to the competent authorities.
The MOH can also withdraw a valid MA in certain cases, such as when a drug is found not to be manufactured at the registered address.
6. Are foreign marketing authorizations recognized?
The MOH does not recognize foreign MAs, but the certification of the drug in the country of origin is one of the required documents for the MA application dossier in Vietnam.
7. Are parallel imports of medicines or devices allowed?
There is no specific regulation on parallel import of medical devices. In practice, parallel imports of medical devices are permitted.
Parallel imports are permitted for drugs, provided the following:
- The drug has the same trade name, active ingredient(s), concentration and dosage form as an original brand-name drug with valid registration number for circulation in Vietnam;
- The drug is manufactured by the same manufacturer as the original brand-name drug, or by another authorized manufacturer; and
- The drug has a lower price than the original brand-name drug being sold in Vietnam.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
It is prohibited to use material or financial benefits in any form to induce physicians or other drug prescribers to promote the prescription and use of drugs. Therefore, giving samples of products to healthcare professionals for promotional purposes is illegal.
Financial and material assistance can be provided for healthcare professional conferences, provided it is done voluntarily, publicly and unconditionally. Therefore, it is likely that pharmaceutical companies (subject to their compliance and other internal policies) can sponsor continuing medical education, provided this sponsorship is unconditional.
The restrictions apply to all Vietnamese healthcare establishments and individuals, regardless of whether the act took place in Vietnam or abroad.
Under the 2018 Law on Anti-Corruption, persons with positions and/or power who are offered a gift must refuse receipt. If they cannot refuse, they must report to their management and hand over the gift to the responsible department within five days of receipt. If the gift is valued at VND 2 million (approximately USD 86) or higher, the giver and receiver may also be subject to criminal liability if the offering of the gift is for corruptive purposes.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The DAV and DMEC have the overall responsibility to supervise the manufacturing of drugs and medical devices, respectively.
A company that wishes to manufacture drugs is required to satisfy regulatory requirements on facilities, techniques and personnel. In particular, such a company needs to obtain necessary licenses to qualify as a drug manufacturing entity, including the Investment Registration Certificate (in the case of a foreign-invested pharmaceutical business entity) and/or the Enterprise Registration Certificate, the Certificate of Eligibility for Pharmaceutical Business and the GMP Certificate.
Companies that engage in the manufacturing of medical devices are required to satisfy regulatory requirements on facilities, equipment, quality management and personnel. The medical device manufacturing entities must submit a declaration of eligibility for manufacturing of medical devices to the provincial DOH and can only commence the manufacturing after obtaining the receipt note for such declaration issued by the provincial DOH.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
The local requirements on GMPs incorporate the GMP standards of the WHO, the Pharmaceutical Inspection Co-operation Scheme (“PIC/S”) and the EMA. The drug manufacturer can apply the GMP standards of either the WHO, the PIC/S or the EMA.
11. What is the inspection regime for manufacturing facilities?
Health Inspectorates from the MOH and the local DOHs are primarily responsible for carrying out inspections at drug manufacturing establishments, which may cover conditions of hygiene, quality of staff, and quality of products.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Generally, foreign inspectors or third-party inspectors do not have the authority to perform inspections of manufacturing facilities in Vietnam.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
Drug storage service providers must ensure that the site, warehouse, storage equipment, vehicles, quality management system, professional materials and personnel meet the standards of Good Storage Practice. For instance, the warehouse must be at a defined location, divided into specialized areas and constructed with firm ceilings, walls and roof.
Packaging of drugs is categorized as a phase of drug manufacturing and the requirements of drug manufacturers are applicable to those engaging in packaging of drugs as well.
14. What information must be included in medicine and device labeling?
The external (secondary) drug package label must show the following:
- Drug name;
- Dosage form;
- Ingredients and the content, volume or concentration of active ingredients;
- Package size;
- Indications, administration, and contraindications;
- Registration number or import license number (if any);
- Lot number, manufacture date, expiry date, quality standard and storage conditions;
- Precautions and recommendations;
- Name and address of the manufacturer;
- Name and address of the importer (for imported medicinal products);
- Origin of the medicine.
The inner (primary) drug package label must show the following:
- Drug name;
- Composition of the product;
- Net weight or volume (not applicable to blister packs);
- Lot number and expiry date;
- Name of the manufacturer.
MEDICAL DEVICE LABELING
The following contents must be shown on labels of medical devices:
- Product name;
- Name and address of registration license holder;
- Registration license or import license number;
- Lot number or serial number;
- Manufacturing date or expiry date;
- Instructions to look up information on alerts, instructions for use and storage, and maintenance outlets for the device.
15. What additional information may be included in labeling and packaging?
Drug labels may show other contents as necessary, provided that they are legal, not aiming at drug advertising and accurately reflect the nature and usage of the drug. Additional contents must not block the mandatory contents and must not use, among other things, information or images prohibited in advertising or product labeling.
Labels for devices may include numeric codes, bar codes, certificate standard marks, certificate regulation marks and other information. Such additional information must be legal and accurate as to the substance of the products, and it must not block or mislead the mandatory information on the label.
16. What items may not be included in labeling and packaging?
A label must not show any picture or information relating to a sovereignty dispute or other sensitive information which may affect the security, politics, economy, society, diplomatic relations, and public decency of Vietnam.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
It is strictly prohibited to advertise prescription drugs or drugs that are subject to limited use or physician-supervised use, or drugs without valid MAs. Drug information documents can be distributed to medical professionals, but not to the general public.
To advertise drugs to the general public, or provide drug information to medical professionals, the approval must be obtained from the DAV for var- ious aspects of the advertisement, such as the content, layout, and form, and the applicant must comply with the approval in the course of advertising. The advertising of drugs before obtaining the DAV approvals is prohibited.
The advertiser of medical devices must obtain a confirmation for advertisement content issued by the DMEC in order to advertise the devices to the public.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Patients can buy drugs at pharmaceutical retail establishments, including drugstores, internal medicine kiosks, and medical stations of communal health clinics. Many medical devices can be purchased in drugstores as well. The purchase of drugs and medical devices by healthcare establishments is done via a tender process.
There are no specific regulations for the sale of medicinal products by mail order. Providing information relating to medicinal products on the internet, company websites, and email for selling purposes can be considered drug advertising, and thus subject to various restrictions (see question 17, above).
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
Drugs can be advertised by various means including websites and e-newspapers. The advertisement of drugs by this means must be done separately, i.e., there must be no advertisement of more than one drug (in one designated space) to avoid confusion.
Entities advertising their own products cannot send an e-mail or text message advertisement without prior consent of the recipients.
20. May medicines and devices be advertised or sold directly to consumers?
Please see question 17 (above).
Medical devices can be advertised directly to consumers via permitted means of advertising for which a confirmation has been issued by the DMEC.
21. How is compliance monitored?
Compliance is monitored by the MOH and provincial DOHs. Health Inspectorates of the MOH and the DOHs are competent to impose penalties in case of non-compliance.
22. What are the potential penalties for noncompliance?
Non-compliance with the regulations on advertising of drugs and devices can subject the advertiser to monetary fines and additional penalties.
For instance, a fine of up to VND 20 million (approximately USD 860) is applicable to the following:
- Advertising of a medical device using contents not consistent with the approved content; or
- Not clearly stating the drug name, active ingredient name, name and address of the entity initially marketing the product, and the instruction “Read the leaflet carefully before using the medicine”.
A fine of up to VND 40 million (approximately USD 1,700) is applicable to the following acts, among others:
- Advertising a drug using information that has not been confirmed by the DAV or is not consistent with the content confirmed by the DAV, the MA certificate or the drug leaflet;
- Advertising a drug for which an MA has not been obtained, or for which the MA is expired;
- Advertising that does not show the drug name, active ingredient name, indications, etc. noncompliant advertiser may also have to make a public correction or remove the advertisement.