The official letter 1178/QLD-ĐK about implementation guideline level 4 public services in the field of drug registration
To: Registered units have drugs circulating in Vietnam
On 23 December, 2015, Health Minister issued Decision No. 5480/QD-BYT on the deployment of level 4 public services in the field of drug registration. Whereby, to carry out pilot online public services for drug registration in form of first registration for the period from 01/01/2016 to 12/31/2016, Drug Administration of Vietnam guides the deployment this service as follows:
I. Guiding some important steps when registering online drugs
1. Registering and getting online drug registration account
1.1. Conditions for getting the account for online drug registration (referred to as account)
Applicant in new drug registration dossiers which is registered the account. Legal document to provide when registering the account as follows:
– Certificate of eligibility for drug trading of Vietnamese applicants;
– License for establishing the representative office in Vietnam or License for operating in the field of drugs, medicinal materials in Vietnam (granted before 01.15.2015) of foreign applicants.
1.2. Registering account.
Applicants access the online drug registration system at “Hệ thống tiếp nhận và xử lý thủ tục đăng ký thuốc” in the electronic page http://www.dav.gov.vn, fill in information form and upload on system the color scan from the original of “certificate of eligibility for drug trading” or “License for establishing the representative office in Vietnam”, or “License for operating in the field of drugs, medicinal materials in Vietnam” in accordance with the type of drug registration as the basis for approving the account by Drug Administration of Vietnam.
1.3. Giving account: within 02 days from receiving of the proposed information for granting the account on the system and accompanying legal documents, Division in charge of granting the account (Drug Administration) will approve the account, the system will send account information for login (including username, password) to email address of the registered representative. Where not approved, the system will automatically inform the reporter reason to know.
1.4. Units must one time-register before the first transaction and using account provided for implementing activities related to drug registration. In case of changing information in legal documents, applicant must perform to modify and upload on the system the scan of legal document like the first time register. To ensure the security, applicant required to change password before using the account to execute the transaction concerned.
2. The online drug registration dossier
The requirements on administrative dossier, technical dossier of online drug registration dossier comply with the provisions of Circular 44/2014/TT-BYT dated 11/24/2014 by Ministry of Health regulating drug registration and submitted as follow:
2.1. Online submitted dossier:
1) Application for registration, the cover page: online declaration according to the form prescribed in Circular 44/2014/TT-BYT.
2) The remaining dossiers: Load data in file format *.pdf, *.doc or *.jpeg up to online drug registration system.
2.2. Dossiers submitted directly (or by post) to Drug Administration together with the receipt code after filing online:
1) The legal documents, including: Application for registration (if the application does not use electronic signature and seal); CPP, GMP certificate; License for producing and trading pharmaceutical products; License for establishing the representative office; other legal documents (if any). Applicant does not have to submit legal paper documents granted by Ministry of Health (Drug Administration of Vietnam).
2) Drug sample.
Time for direct submission of dossier and drug sample: Applicant may file these in the period after online submission to prior to the completion of payment of registration fees as notified by system.
3. Paying appraisal fees for drug registration dossiers
After receiving online drug registration dossier, the system will automatically inform the registration fee and applicant must pay registration fee no later than 30 days from the end of the filing online. Receiving time of dossier is calculated starting from the date of completion of paying registration fee.
In the pilot stage, applicant can pay fees by bank transfer or directly at Drug Administration following current process.
4. Announcing the results of online drug registration.
Processing and settlement results of online drug registration public services announced for each dossier by Drug Administration when accessing the account of Applicant. Results of processing online drug registration dossier include the following documents:
1) Official letters of appraisal results
2) Decision granting the registration numbers, List of visa numbers attached to decision, Labels, Package Insert/Summary of Product Characteristics, Marketing Authorization (for drug granted registration number).
1. Encourage the Applicant to register online drug. During the pilot implementation, units may choose to apply registration dossiers under both systems (complete paper or online submission) in different dossiers.
2. The paper and online submission system is considered independently under current regulations on drug registration. The evaluation results and granting registration numbers through the online drug registration system are granted in writing with electronic signature and seal granted by Cipher Commission of Government, these writing are as valid as the corresponding documents issued by the paper drug registration system.
3. The paper dossiers were submitted before the date of this guide are not converted to the electronic dossiers until the end of the pilot stage.
4. Drug Administration in collaboration with the software development unit has developed documentation and video guiding how to use the online public services system level 4. Recommend units download documentation at “hệ thống tiếp nhận và xử lý thủ tục đăng ký thuốc” on electronic website http://www.dav.gov.vn. For implementation study.
5. The process of online drug registration dossier submission and the process of receiving, handling online registration dossier will be updated and published on the website http://www.dav.gov.vn by Drug Administration of Vietnam.
Drug Administration informs Applicants, Manufacturers to know and implement. In the course of implementation, if any difficulties or problems arise, please contact with Drug Administration Office (Tel: 04.37366483), Drug Registration Division (Tel: 04.37368258) or technical staff of Viettel (Duong Xuan Linh, Tel: 097.258.4868; Vu Thi Guong, Tel: 097.582.3927) for assistance or documents sent Drug Administration to promptly resolve.
|DEPUTY DIRECTOR OF DRUG ADMINISTRATION OF VIETNAM
NGUYEN VIET HUNG
Public services in the field of drug registration