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 GBP 119.
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 registration number or import license.
The registration number for Class A and B (lowest-risk) medical devices is simply the number of a declaration letter 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 declaration letter.
The registration number for Class 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 45 days, while the timeline under the quick and emergency procedures will be only 10 days from the submission date of the complete dossier. In practice, however, the DMEC normally does not yet have the capacity to evaluate these dossiers in a timely manner.
During the transition period as the latest regulations are phased in, import licenses for medical devices that were granted after 1 January 2018 will be valid until 31 December 2022 while Class C/D medical devices that are not subject to import licenses, and whose classification results were published on the Portal of Medical Device Management, can continue to be imported until 31 December 2022, with no limit on quantity and without an approval letter from the MOH.
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/medical device 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 that are offered a gift must refuse receipt. If he/she cannot refuse, he/she must report to his/her 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 self-declare by uploading the required dossier on the Portal of Medical Device Management under the MOH, and then the provincial DOH will publish the relevant information and the declared dossier on the Portal. After that, the entities are allowed to manufacture medical devices.
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;
- Name and address of the product owner;
- Origin (specify the place(s) where the final production stage is conducted to complete the products if the origin cannot be determined);
- Registration license or import license number;
- Lot number or serial number;
- Manufacturing date or expiry date;
- Information or 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 various 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 holders of medical device registration numbers or their authorized entities will be responsible for publicly declaring the intended content and form of the advertising on the Portal of Medical Device Management before conducting the advertising.
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 drug stores, internal medicine kiosks, and medical stations of communal health clinics. Many medical devices can be purchased in drug stores 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 the intended content and the form of the advertising are publicly declared on the Portal of Medical Device Management.
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 40 million (approximately USD 1,700) is applicable to the following:
- Advertising contrary to the features and effects of the medical devices;
- Concealing warnings related to incidents and undesirable effects of medical devices;
- Advertising without the name, model, manufacturer, manufacturing country or the name and address of the organization or individual responsible for bringing the product to market and the organization or individual responsible for the warranty.
A fine of up to VND 80 million (approximately USD 3,400) 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.
A noncompliant advertiser may also have to make a public correction or remove the advertisement.