Circular No. 28/2011/TT-BYT amending and supplementing a number of articles of Circular No. 13/2010/TT-BYT of 12 May 2010 guiding the management of quick food test kits

26 Issue nos 01-02JOctober 2011 (Gong Uao nos5J5-5J6IOcfober 25, 2011) Circular No. 2812011/TT-BYT of June 24, 2011, amending and supplemen ting a number of articles of Circular No. 13/2010/TT·BYT of May 12,2010, guiding themanagement of quick food test kits Pursuant to the Government's Decree No. 188!2007IND-CP of December 27, 2007, defining the functions, tasks, powers and organizational structu re (~j' the Min istrv of Health; In performing the simplification of administrative procedures in the spirit of the Government's Resolution No. 62INQ-CP o] December 17, 2010, 011 simplification of admintstrauve procedures under the Ministrv ofHealui's management: The Minister (4 Health issues the circular amending and supplementing (J number of articles ofCircular No. 121201OfTTBYT ofMa» 12, 2010, guiding the management of quick food test kits. as follows: Article 1. To amend and supplement a number of articles of Circular No. [212010/ TTBYT of May [2, 2010, guidi ng the management of quick food test kits 1. To amend and supplement Article 9 as follows: "Article 9. Forms of circulation registration; modified and supplemented circu lati 011 renistrurion, and extension of circulation Issue nos 01.02l0ctober 2011 (Cong Baanos 535-53610ctober 25, 2011) registration of quick food test kits 1.Circulation registration of quick food test kits Enterprises shall submit dossiers of request under Clause 1, Article 10 of this Circular. 2. Modified and supplemented circulation registration at For quick food test kits which already have circulation registration certificates, during the validity term of their certificates, approval of registration certificate-issuing agencies is required for change or supplementation of any of their registered contents; bl When changing or adding any of the follow i ng contents, an euterpri se shall submit a dossier of request under Clause 2, Article 10 of this Circular; the registration certificate issuing agency shall consider retain the circulation registration number and the granted circulation registration certi ficate: Change of the life time or preservation conditions; Change (supplementation) of label contents; Change of scope of application; Change of limit of finding; Change (supplementation) of use instructions; Change of information on preciseness (or error); Change (supplementation) of packaging spcci ficutions, 27 c/ When changing or supplementing any of the following registered contents, procedures shall be carried out as in the case of circulation registration; enterprises shall submit dossiers of request under Clause 1, Article 10 of this Circular; registration certi f icate-i ssuing agencies shall revoke the granted certificates and registration numbers and carry out procedures for considering the issuance of new ones: Change (suppleme ntati on) of testi ng indicators; Change of operational principles; Change of testing characteristics; Change of name of the quick test kit; Change of the enterprise requesting the registration. 3. Extension of circulation registration of quick food test kits Within 3 months before the expiration of its circulation registration certi ficate, an enterprise shall submit a dossier of request for circu lation registration extension according to Clause 3, Article 10 of this Circular if thei . quick food test kits continue being circulated in Vietnam. Past that tirne limit, if the enterprise fails {O complete procedures for extension, it shall <;11hmit :1 do ssier of fPf]. nest for circula lion registration under Clause 1, Article JO of this Circular." 2. To amend and supplement Article 10 us follows: 28 Of f ICIM GAlEP r Issue nos 01·02l0ctober 2011 (Gong BaD nos 535-53610ctober 25, 2011) --- .. - ..' .. ------' .. -- .,-- .. ----- .- . - . ... , "Article 10. Dossiers of request tor circulation registration and modified and supplemented circulation registration, or extension of circulation registration of quick food test kits I. A dossier of request for circulation registration of a quick food test kit An enterprise shall submit to the registration certificate-issuing agency 1 set of dossier of request for circulation registration (enclosed with a list of attached documents) which comprises: aJAn application for circulation registration of a quick food test kit (made according to the form provided in Appendix I to this Circular); b/ A copy of the business registration certificate (wi th the enterpri sc's ccrti fication); c! Research and testing documents related to the quick food test kit Foreign-language documents must be enclosed with their Vietnamese translations (with the enterprise's certification); d/ Instructions for use of the quick food test kit. Foreign-language usc instructions must be enclosed with their Vietnamese translations (with the enterprise's certification); el Reports on results of testing of the quick food test kit of three technical units selected by the enterprise itself from the list of technical units annually announced by the Ministry of Health; f/ One sample of labels of the quick food test kit, including the direct label on the smallest package unit and the label on the indirect package (bearing the enterprise's seal): g/ A copy of the circulation permit in the country of manufacture or exportation, granted by a competent state agellCY of this country (for case of registration of an imported quick food test kit) and legalized by a consulate, in English or Vietnamese. For a circulation permit in another foreign language, it must bc enclosed with its notarized Vietnamese translation: h/ Two samples of the quick food test kit 2. Dossiers of request for change or supplementation of registered contents of quick food test kits Whcn there is a change of or supplement to a can tent speci lied in Clause 2, Artie le 9 of this Circular, the enterprise shall submit to the certi ficate -issu ing age ncy one dossi er set (enclosed with a list of attached documents). which comprises: a/ A written request for change of a content of the circulation registration of the quick food test kit (made according to the form provided in Appendix II to this Circular); b/ A copy of the circulation regisllaliolJ certificate (including the first-time certificate and extended certificates): c/ Documents related to the change or supple mr-nta tion of the registered content Foreign-language documents must be enclosed with their Vietnamese translations (with the enterprise's certification): Issue nos01·02lOctober 2011 (Gong Bao nos 535-53610ctober 25,2011) 29 d/ Two samples of the quick food test kit. 3. Dossiers of request for extension of circulation registration of quick food test kits The enterprise shall submit to the certificate issuing agency one dossier set of request for ex tensi on of the circulation registration (enclosed with a list of attached documents), which comprises: a/ A written request for extension of the circulation registration certificate (made according to the form provided in Appendix III to this Circular); bl A copy of the circulation registration certificate (including the first-time certificate und extended certificates); c/ One sample of the quick food test kit; dJ Documents certifying the stability and special effect of at least one technical unit having used the quick food test kit." 3. To amend and supplement Article 11 as follows: "Article 11. Competence and procedures for considering the issuance of certificates and circulation registrar iUII number s fur 4 uick fUUlI test kits I. The Ministry of Health authorizes the Food Safely Administration to ex.amine dossiers and issue circulation registration certificates and numbers to q uic k food lest ki ts. 2. The Food Safety Administration shall: al Receive dossier s uf rcq ue st for registration; bl Set up a specialized appraisal council to eval uate the kit: To examine, appraise and make conclusions on scientific grounds and practicality of the quick food {est kit and advise the Ministry of Health (the Food Safety Administration) on c.onsidi':ring and evaluating the kit; To propose the way of making circulation registration for the kit. e!On the basis of conclusions and proposals of the council, the Director of the Food Safety Administration shall decide to: Permit the circulation of a quick food test kit by issuing a circulation registration certificate to the kit or renewing its certificate (for cases of change or supplementation); Request addition of information and documents before permitting circulation by notifying such in writing to the enterprise, clearly stating the request; Disallow the circulation registration by notifying such in writing to the enterprise, clearly stating the reason. d/ Time limit for replying enterprises: Twenty working days after the date of snhm issmn of a va lid dossier, for dossiers of circulation registration of quick food test kits; Ten working days after the date of submission of a valid dossier, for dossier!'> of modified and supplemented circulation registration of quick food test kits; . 'LEGAl 30 Five working days after the date of submission of a valid dossier, for dossiers of registration of extension of quick food test kits. 3. Validity term of certificates of circulation registration of quick food test kits: aJA certificate of circulation registration of a quick food test kit is valid for 5 ycurs after the dale of its signing; bl A certificate of circulation registration of a quick food test kit may be extended many times with each extension valid for 5 years after the date of its signing; cl For quick Food test kits already have certificates of circulation registration issued under the Minister ofHealth's Decision No. 18/ 2007/QD-BYT of February 27, 2007, promulgating the Regulation on management of quick testing of food hygiene and safety, enterprises shall carry out procedures for extending these certificates upon thc expiration of their 5-year validity term. Article 2. Effect This Circular takes effect on August 10, 20 t1. For the Minister ofHealth Deputy Minister TRINH QUAN HUAN Issue nos01-02l0ctober 2011 (Gong Bao nos535-536/0ctober 25, 2011)