Công văn 3048/BYT-TB-CT năm 2014 hướng dẫn tạm thời việc gia hạn số đăng ký, thời hạn nộp hồ sơ đăng ký lại sinh phẩm chẩn đoán invitro do Bộ Y tế ban hành

Pursuant to the Decision No. 1188/QD-BYT dated April 08, 2014 by Minister of Health on functions, missions, authority and organizational structure of the Department of Medical Device and Construction - Ministry of Health, the authority over in vitro diagnostic reagents shall be transferred from the Drug Administration of Vietnam to the Department of Medical Device and Construction in order to facilitate the integration into ASEAN and the world.

At present, Circular No. 22/2009/TT-BYT dated November 24, 2009 on drug registration applies to registration of in vitro diagnostic reagents. Ministry of Health is reviewing regulations on harmonization of medical devices in ASEAN and across the world in order to produce documents for management of in vitro diagnostic reagents in conformity and in succession to existing regulations.

Ministry of Health hereby introduces the interim policy for extension of registration number and time limit for re-registration to ease current burdens on enterprises and to facilitate business demands of enterprises registering in vitro diagnostic reagents for free sale in Vietnam, particular bidders having won contracts for provision of in vitro diagnostic reagents for health facilities pending the completion of revisions to the Circular No. 22/2009/TT-BYT and written guidelines for registration of in vitro diagnostic reagents in conformity to regulated procedures and legislative documents.

I. Extension of registration number:

1. Ministry of Health shall consider applications for extension of the validity of expired registration number of in vitro diagnostic reagents upon the satisfaction of all conditions below:

a) An application for re-registration has been submitted to the Ministry of Health prior to the date of expiry but the registration number has not been renewed;

b) A contract awarding letter has been released by a health facility prior to the date of expiry but the registration number has not been renewed;

c) An application for extension of registration number validity has been filed by the organization producing and trading drugs according to Section 2, Part I of this document.

2. An application for extension of registration number validity includes:

a) A letter of request for extension of registration number validity, which indicates reasons of such request;

b) Originals or notarized copies of:

- A contract awarding letter from a health facility. Such letter must be submitted in 6 months or 1 year upon its issuance by a health facility that invites bids for the in vitro diagnostic reagent to be re-registered every 6 months or every year, respectively.

- A contract for provision of the re-registered in vitro diagnostic reagent to a health facility.

3. Extendable duration and effect:

a) The validity of the existing registration number shall be extended for at most 06 months upon the Ministry of Health’s approval of extension in writing. During the validity period of the registration number, the relevant vitro diagnostic reagent shall be produced and imported according to registration documents retained by the Ministry of Health. Such reagent may be sold until its date of expiry.

b) Application for extension of validity period of registration number of in vitro diagnostic reagents shall be considered until the relevant provisions in the Circular No. 22/2009/TT-BYT are amended or replaced.

II. Submission and verification of applications for re-registration

An application for re-registration must be filed in 12 months’ time prior to the date of expiry of the existing registration number. If such application does not meet requirements for renewal of the registration number prior to its date of expiry, the Ministry of Health shall consider renewal after the expiration of the number.

Difficulties shall be reported by Departments of Health or organizations to the Ministry of Health (Department of Medical Device and Construction) in a timely manner for solutions./.

---------------

This document is handled by Dữ Liệu Pháp Luật . Document reference purposes only. Any comments, please send to email: [email protected]