Decision No. 01/2000/QD-BTS dated January 03, 2000 of the Ministry of Aquatic Products promulgating the regulation on inspection and certification of aquatic goods production and/or business establishments meeting the standards on food hygiene and safety

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Decision No. 01/2000/QD-BTS dated January 03, 2000 of the Ministry of Aquatic Products promulgating the regulation on inspection and certification of aquatic goods production and/or business establishments meeting the standards on food hygiene and safety
Issuing body: Ministry of Aquatic ProductsEffective date:Updating
Official number:01/2000/QD-BTSSigner:Ta Quang Ngoc
Type:DecisionExpiry date:
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Issuing date:03/01/2000Effect status:
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Fields:Aquatic products , Food and drug
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THE MINISTRY OF AQUATIC RESOURCES
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SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom Happiness
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No. 01/2000/QD-BTS
Hanoi, January 3, 2000
 
DECISION
PROMULGATING THE REGULATION ON INSPECTION AND CERTIFICATION OF AQUATIC GOODS PRODUCTION AND/OR BUSINESS ESTABLISHMENTS MEETING THE STANDARDS ON FOOD HYGIENE AND SAFETY
THE MINISTER OF AQUATIC RESOURCES
Pursuant to Decree No.50/CP of June 21, 1994 of the Government defining the tasks, powers and organizational structure of the Ministry of Aquatic Resources;
Pursuant to Decree No.86/CP of December 8, 1995 of the Government assigning the responsibility of State management over goods quality;
Pursuant to Circular No.02 TT/LB of May 24, 1996 jointly issued by the Ministry of Science, Technology and Environment and the Ministry of Aquatic Resources guiding the implementation of Decree No.86/CP;
At the proposal of the director of the Science and Technology Department,
DECIDES:
Article 1.- To promulgate together with this Decision the Regulation on Inspection and Certification of Aquatic Goods Production and/or Business Establishments Meeting the Standards on Food Hygiene and Safety.
Article 2.- Organizations and individuals producing and/or trading in aquatic food, the inspecting bodies and the agencies granting the certificates of qualifications for food hygiene and safety shall have to implement this Regulation.
The following objects shall not be governed by this Regulation:
a) Family household- scale establishments processing aquatic products for retail.
b) Establishments retailing aquatic products, aquatic food catering service establishments
c) Fishing ships with the main engine capacity of under 90 cv
d) Fishing boats operated manually.
e) Fish wharves (manual)
f) Establishments processing aquatic products not used as food.
Article 3.- The director of the Science and Technology Department shall have to guide the implementation of this Regulation. The previous provisions contrary to this Regulation shall all be annulled.
Article 4.- The Office director, the Department directors, the inspector, the head of Aquatic Resources Protection Department, the director of the Center for Aquatic Products Quality and Hygiene Inspection, the directors of the provincial/municipal Aquatic Resources Services and of the provincial/municipal Agriculture and Rural Development Services managing aquatic resources shall have to implement this Decision.
 

 
THE MINISTER OF AQUATIC RESOURCES




Ta Quang Ngoc
 
REGULATION
ON INSPECTING AND CERTIFYING AQUATIC GOODS PRODUCTION AND/OR BUSINESS ESTABLISHMENTS MEETING THE STANDARDS ON FOOD HYGIENE AND SAFETY
(Promulgated together with Decision No.01/2000/QD-BTS of January 03, 2000 of the Minister of Aquatic Resources)
Chapter I
GENERAL PROVISIONS
Article 1.- Objects and scope of application
1. This Regulation prescribes the order and procedures for inspecting and certifying aquatic goods production and/or business establishments (hereafter referred to as establishments) meeting the standards on food hygiene and safety (hereafter abbreviated as FHS).
2. Objects governed by this Regulation shall be:
a) Establishments processing, packing and/or preserving aquatic products used as food by industrial mode, that register their operation under the Law on Enterprises.
b) Establishments processing or preliminarily processing aquatic products by manual mode, which register their operation under the Law on Enterprises; aquatic products gathering, cleaning and/or preserving establishments; fishing ships; fish ports, semi-extensive, extensive, industrial aquaculture establishments; aquatic products raw materials wholesale markets; motor vehicle used exclusively for transportation of aquatic products.
Article 2.- Term interpretation
In this Regulation, the following terms shall be construed as follows:
1. Establishments processing, packing and/or preserving aquatic products by industrial mode means the aquatic goods-producing establishments where the mechanical, thermal, electrical and refrigerating equipment play the decisive role in the technological chains of aquatic product processing, packing and/or preserving.
2. Establishments processing or preliminarily processing aquatic products by manual mode means the aquatic goods-producing establishments where mechanical and electrical equipment only play the support role in the technological chains of aquatic product processing or preliminary processing.
3. Semi-intensive, intensive or industrial aquaculture establishments means the commercial aquaculture establishments which use artificial breeds, processed feeds and mechanical and electrical equipment to carry out the aquaculture process.
4. Fish ports mean special-use construction works furnished with mechanical equipment for receiving, loading and unloading, treating and/or preserving aquatic product raw materials from fishing ships and providing services for fishing ships.
5. Aquatic product raw materials wholesale markets means special-use construction works for the purpose of wholesaling aquatic product raw materials.
6. Fishing ships are motorized water means used exclusively for exploitation, gathering, preservation and/or transportation of aquatic product raw materials.
Article 3.- Bases for inspection and certification of establishments meeting the FHS standards
1. The bases for inspection and certification of establishments meeting the FHS standards shall be the Vietnamese Standards, the Aquatic Resource Branch’s Standards and other provisions of the Ministry of Aquatic Resources on conditions to ensure FHS and the FHS control system which must be applied to each type of establishment.
2. The duration and contents of standards compulsorily applied to each type of establishment stated in Clause 2, Article 1, stipulated by the Ministry of Aquatic Resources for each period.
3. For establishments processing and/or packing aquatic products for export to countries with requirements and standards different from Vietnamese regulations, the FHS inspection and certification shall be based on the standards and regulations of the importing countries, which are recognized and permitted for application by the Ministry of Aquatic Resources.
Article 4.- Agencies inspecting the conditions to ensure FHS
1. The agencies inspecting conditions to ensure FHS (hereafter called the inspecting agencies for short) include two levels: The central inspecting agency and the local inspecting agencies (of the provincial and municipal level).
2. The central inspecting agency is the Center for Inspection of Aquatic Product Quality and Hygiene: having the responsibility to inspect the conditions to ensure FHS for types of establishments stated at Point a, Clause 2, Article 1 of this Regulation.
3. The local inspecting agencies are Sub-Departments for Aquatic Resources Protection; in localities where such Sub-Departments are not available, the local inspecting agencies shall be nominated by the provincial/municipal Agriculture and Rural Development Services after obtaining opinions of the Ministry of Aquatic Resources. These agencies shall have to inspect the conditions to ensure FHS for establishments stationed in the localities, as stated at Point b, Clause 2, Article 1 of this Regulation.
4. For localities lacking the organizational and personnel conditions to perform the inspection task, the central inspecting agency shall have to inspect the establishments stated at Point b, Clause 2, Article 1 in such localities, and at the same time guide and support the localities to build the local inspecting agencies.
Article 5.- Forms of inspection and examination
1. First-time inspection: The first-time inspection shall apply to:
a) Establishments which have not yet been inspected and granted certificates;
b) Establishments which have already been granted certificates but change their production locations.
2. Re-inspection: The re-inspection shall apply to:
a) Establishments which have already been inspected but failed to meet the conditions for being granted the certificates;
b) Establishments which have already been granted certificates, but later:
- Re-arrange or expand their production ground;
- Replace major technological equipment;
- Turn out products other than those already registered.
c) Establishments which have their certificates revoked or invalidated, after rectifying their errors.
3. Periodical inspection shall comply with the plans of the inspecting agencies in order to determine the maintenance of conditions to ensure the FHS of establishments already granted certificates.
4. Unexpected inspection is a measure applied by inspecting agencies when necessary without notifying establishments in advance.
5. Examination is a measure taken by certifying agencies in the following cases:
a) where establishments complain in writing about the conclusions of inspecting agencies;
b) where it is so needed in order to satisfy the managerial requirements.
Article 6.- Certifying agencies
1. Agencies certifying establishments meeting FHS standards (hereafter called the certifying agencies for short) include two levels: At the central level, it is the Ministry of Aquatic Resources; in the provinces and centrally-run cities, they are the provincial/municipal Aquatic Resources Services or the provincial/municipal Agriculture and Rural Development Services managing aquatic resources.
2. The Ministry of Aquatic Resources shall provide certification for establishments stated at Point a, Clause 2, Article 1 of this Regulation.
3. The provincial/municipal Aquatic Resources Services or the provincial/municipal Agriculture and Rural Development Services managing aquatic resources shall provide certification for establishments in localities as stated at Point b, Clause 2, Article 1 of this Regulation.
Article 7.- Certificates
1. The certificate of FHS standards (hereafter called the certificate for short) is a legally valid document issued by the competent bodies stated in Article 6 according to the provisions of this Regulation, certifying that establishments meet the standards on conditions to ensure FHS for carrying out aquatic food production and business activities.
2. Where an establishment has two independent workshops or more, the certificate must clearly state the name(s) of the workshops which meet the FHS standards.
3. The certificate is valid only for the establishment or workshop clearly defined therein.
4. The certificate form shall be issued by the Ministry of Aquatic Resource for uniform application nationwide.
5. The central inspecting agency shall have to organize the printing and management of certificate form according to the State regime on management of printed matters.
6. Each certificate is made into 01 (one) original and 02 (two) duplicates. The original shall be handed to the establishment granted the certificate, 1 copy shall be kept at the certifying agency and 1 copy shall be sent to the inspecting agency of the same level.
7. Each establishment or workshop, which is granted the certificate, shall be given a code. The code system shall be stipulated by the Ministry of Aquatic Resource and uniformly applied nationwide.
Chapter II
INSPECTION OF CONDITIONS TO ENSURE FHS
Article 8.- Inspection registration
1. Establishments shall have to register with inspecting agencies according to the assignment of responsibility stated in Article 4 for the inspection of their conditions to ensure FHS.
2. The dossier of registration for the first-time inspection for establishments stated in Item a, Clause 2, Article 1:
An establishment shall have to submit two sets of dossier of inspection registration, each set shall include:
a) The copy of the registration paper for production, trading and/or processing of aquatic products;
b) The inspection registration paper;
c) The drawing of the arrangement of the entire flooring space of the establishment on A3-size paper, fully reflecting the principal processes of the technological chain of production;
d) The list of major products and the plan of the technological process of production;
e) The list of major technological equipment;
f) The report on the establishment’s conditions to ensure FHS.
3. The dossier of registration for first-time inspection for establishments stated at Item b, Clause 2, Article 1:
An establishment shall submit 02 sets of dossier of inspection registration; each set shall include:
a) The inspection registration paper;
b) The drawing of the plan of the establishment’s flooring space, on A4-size paper, clearly reflecting construction items directly related to the FHS of aquatic raw materials, semi-finished products and products;
c) The copy of the aquatic products practicing license;
d) The report on the establishment’s conditions to meet the FHS.
4. The dossier of registration for re-inspection: An establishment shall submit 02 sets of dossier of re-inspection registration; each set shall include:
a) The re-inspection registration paper;
b) The report on changes in the conditions to ensure FHS, clearly stating changes in the FHS conditions as compared with the previous inspection, including remedial measures already taken to rectify errors (if any).
5. The inspection and re-inspection registration forms and the form of report on the establishments’ conditions to ensure FHS as stated in Clauses 2, 3 and 4 of this Article shall be stipulated by the central inspecting agency and uniformly applied nationwide.
Article 9.- Registration certification and inspection notice
Upon receiving the inspection registration dossiers, the inspecting agencies shall proceed:
1. To examine the dossiers and guide establishments to supplement insufficient contents.
2. To certify their full receipt of registration dossiers of establishments.
3. Within 7 (seven) days after the receipt of the full registration dossiers, to notify in writing the establishments of the inspection time and contents, and standards to be used as bases for the inspection.
Article 10.- Setting up inspection teams/ examination teams
1. The heads of the inspecting agencies shall issue decisions to set up team for inspection of the conditions to ensure FHS for establishments under the first-time inspection, re-inspection or unexpected inspection. The regular inspection shall comply with the plans of the inspecting agencies, without having to issue decisions thereon.
2. The heads of the certifying agencies shall issue decisions to set up examination teams in cases stated in Clause 5, Article 5.
3. A decision to set up an inspection team or an examination team should clearly state:
a) The scope of inspection and responsibilities of the team;
b) The name of the establishment to be inspected;
c) The full names and titles of the team leader and members.
4. Members of inspection teams or examination teams are cadres having graduated from training courses on inspection operations, having experiences in the work of inspection of conditions to ensure FHS in the field of aquatic products.
Article 11.- Inspection contents and methods
1. The inspection contents must comply with the provisions on standards regarding the conditions to ensure FHS of the type of establishment to be inspected.
2. The inspection method, the list of groups of items to be inspected, the method of evaluating the extent of error for each group of item, the classification criteria applicable to each type of establishment shall be elaborated by the central inspecting agency, and submitted to the Ministry of Aquatic Resources for promulgation and uniform application nationwide.
3. The inspection teams shall have to assess all contents and groups of items to be inspected according to the provisions in Clause 2 of this Article; and at the same time classify establishments according to the extents of ensuring FHS into the 4 following class:
a) Class A: Meeting the FHS standards;
b) Class B: Being found with some minor errors which cause minimal impacts on FHS for aquatic products;
c) Class C: Being found with some grave errors which may affect FHS of the products, but not seriously;
d) Class D: Being found with many serious errors, which cannot be rectified within a short period of time, which shall seriously affect the FHS of the aquatic products if production continues.
4. The regular and unexpected inspection contents and items shall be stipulated by the inspecting agencies on the case-by-case basis.
Article 12.- Inspection frequency
The regular inspection frequency for establishments is stipulated as follows:
1. For establishments stated at Point a, Clause 2, Article 1:
a) Class A establishments: 02 (two) times/year
b) Class B establishments: 04 (four) times/year
c) Class C establishments: 12 (twelve) times/year
d) Class D establishments: 24 (twenty-four) times/year.
2. For establishments stated at Point b, Clause 2, Article 1:
a) Class A establishments: 01 (one) time/year
b) Class B establishments: 02 (two) times/year
c) Class C establishments: 06 (six) times/year
d) Class D establishments: 12 (twelve) times/year.
Article 13.- Inspection minutes
1. The form of inspection minutes shall be elaborated by the central inspecting agency for each type of establishment, submitted to the Ministry of Aquatic Resources for promulgation and uniform application nationwide.
2. The inspection minutes must:
a) Be made according to set form right at the establishments after the end of inspection;
b) Fully and accurately reflect the inspection results;
c) Be clearly inscribed with the to be-rectified contents of items which have failed to meet the standards and regulations (if any);
d) Clearly state the opinions of the inspection teams, the classification of extent of ensuring the FHS by the establishments, according to the provisions in Clause 3, Article 11;
e) Be signed by the inspection team leader and the competent representative of the establishment, stamped with the seal of the inspected establishment;
f) Be made in 2 (two) copies: 1 copy is kept at the inspecting agency, 1 copy is handed over to the establishment.
3. If disagreeing with the conclusions of the inspection team, the establishment’s representative may inscribe his/her proposal and/or complaints, including request for re-investigation or examination, at the end of the minutes before signing and stamping for certification.
Chapter III
GRANTING, INVALIDATING AND WITHDRAWING CERTIFICATES
Article 14.- Granting certificates
1. For establishments under the first-time inspection, reaching Class A or Class B as stipulated in Clause 3, Article 11, within 07 (seven) days after the inspection, the inspecting agencies shall have to forward the dossiers to the certifying agencies, proposing the granting of certificates to the establishments.
2. A dossier proposing the granting of certificate shall include:
a) The dossier of inspection registration of the establishment stated in Clauses 1 and 2, Article 8;
b) The inspection minutes of the inspection team;
c) The document of the head of the inspecting agency proposing the granting of certificate to the establishment.
3. Within 07 (seven) days after fully receiving the dossiers, the certifying agency shall have to issue a decision to grant certificate to the establishment. In cases where examination is required, there must be a document notifying the examining agency and the establishment thereof.
4. After granting the certificate, the dossier proposing the granting of certificate shall be returned to the inspecting agency of the same level and archived thereat.
5. Particularly for Class B establishments:
a) The head of the inspecting agency shall send a written request to the establishment, which is made in 02 (two) copies, 1 copy is sent to the establishment, 1 copy is kept at the inspecting agency.
b) The content of such request: clearly stating item to be rectified and the time limit for the complete rectification of such items.
c) During the above-said time limit, the establishment is allowed to conduct its production activities as usual.
Article 15.- Cases of failure to satisfy conditions for being granted certificates
For establishments under the first-time inspection, which fail to satisfy the conditions to ensure FHS (Class C and Class D), basing themselves on the inspection minutes, the inspecting agencies and the certifying agencies shall, within 07 (seven) days after the inspection, have to apply the following measures:
1. For Class C establishments:
a) The head of the inspecting agency sends a notice on failure to satisfy the standards regarding the conditions to ensure FHS to the concerned establishment. The notice is made in 03(three) copies: 1 copy is sent to the establishment, 1 is kept at the inspecting agency, 1 is sent to the certificate-granting agency for report, together with the copy of the inspection minutes.
b) The notice content:
- The reason for not granting the certificate: Items failing to meet requirements;
- The time limit for rectification of items which have failed to meet the requirements;
- The notification on increase of frequency of inspection of conditions to ensure FHS and taking samples on production chains for inspection.
c) Within the above-said time limit, the establishment may carry out production activities, but its products, when being delivered, must be closely inspected.
2. For Class D establishments:
a) Within 07 (seven) days after the inspection, the inspecting agency shall have to send all dossiers to the certifying agency, clearly stating the reasons and proposal for not granting the certificate to the establishment;
b) Within no more than 15 days after fully receiving the dossiers, the head of the certifying agency shall examine them and send a notice on non-granting of certificate. The notice is made in 04(four) copies: 1 copy is sent to the establishment, 1 is kept at the certifying agency, 1 is sent to the inspecting agency, and 1 is sent to the agency which has issued the establishment decision or the agency which has granted the production/business registration to the establishment.
c) The notice contents:
- Clearly stating the number of errors and the seriousness of such errors;
- Stipulating the items to be rectified;
- Proposing the agency which has issued the decision on setting up of the establishment to notify the suspension of production/delivery till the erroneous items are rectified;
- Requesting the State quality inspection bodies not to grant the quality certificate and the hygiene deed to the products of the establishment.
d) After receiving the notice, the State quality inspection bodies must not grant the State certificate of quality or the hygiene deed to the products of the establishment.
Article 16.- For establishments which have been granted certificates but committed violations
For establishments which have already been granted certificates, but failed to well maintain the conditions to ensure the FHS, basing themselves on the inspection minutes, the inspecting agency and the certifying agency shall, within 07 (seven) days after the inspection, have to apply the following measures:
1. For Class B establishments: The handling shall comply with Clause 5, Article 14.
2. For Class C establishments:
a) The head of the inspecting agency shall send the violation warning, which is made in 03(three) copies: 1 copy is sent to the establishment, 1 is kept at the inspecting agency, and 1 sent to the certifying agency for report, attached with the copy of the inspection minutes.
b) The warning contents:
- The reason(s) for warning: Items have degenerated, failing to meet requirements;
- The time limit for rectification of items which have failed to meet the requirements;
- The notification on increase of frequency of inspection of the conditions to ensure FHS and taking samples on production chain for inspection.
c) Within the prescribed time limit, the establishment is allowed to carry out production activities, but its products, when being delivered, must be closely inspected by the inspecting agency.
3. For Class D establishments:
a) Within 07 (seven) days after the inspection, the inspecting agency shall have to fully send the dossiers to the certifying agency, clearly stating the reason(s) and proposal for invalidation of the certificate already granted to the establishment.
b) Within not more than 15 days after fully receiving the dossiers, the head of the certifying agency shall examine them and send a notice on the invalidation of the certificate already granted to the establishment. The notice is made in 04 (four) copies: 1 copy is sent to the establishment, 1 to the inspecting agency, 1 to the agency which has issued the establishment decision or the agency which has granted production/business registration to the establishment, and 1 is kept at the certifying agency.
c) The notice contents:
- Stating clearly the number of errors and the seriousness of such errors;
- Stipulating items to be rectified;
- Proposing the agency which has issued the decision to set up the establishment to notify the suspension of production/delivery till the erroneous items are completely rectified;
- Requesting the State quality inspection bodies not to grant the quality certificates and hygiene deeds to the products of the establishment.
d) After receiving the notice, the State quality inspection bodies shall suspend the granting of certificates or hygiene deeds to the products of the establishments till a new decision is made by the certifying agency.
Article 17.- Invalidation of certificates
1. In the following cases, the head of the inspecting agency shall send a document fully attached with dossiers to the certifying agency, requesting the latter to issue a decision to invalidate for a definite period of time the certificates already granted to:
a) Establishments rated Class D;
b) Establishments rated Class C for more than 6 months without applying any measures to rectify the errors;
c) Establishments which fail to abide by the written requests of the inspecting agency for the maintenance of conditions to ensure FHS for two times or more;
d) Establishments which have 2 successive goods lots subject to warning by the inspecting agencies at home or abroad, but have not rectified the errors in time;
e) Establishments which deliberately breach the regulations on the use of granted certificates and codes, seriously violate the regulations on ensuring FHS.
2. The head of the certifying agency shall examine them and issue a decision to suspend for a definite period of time the validity of the granted certificate. The decision is made in 4 (four) copies: 1 copy is sent to the establishment, 1 kept at the certificate-granting agency, 1 sent to the inspecting agency and 1 to the agency which has decided the setting up of the establishment or the agency which has granted the production/business license to the establishment.
3. After receiving the decision, the State quality inspection bodies shall suspend the granting of certificates or hygiene deeds to products of the establishment till a new decision is issued by the certifying agency.
Article 18.- Restoring the validity of certificates
1. Within the prescribed time limit, after completely rectifying the errors, the establishment having its certificate invalidated shall register its application for re-inspection according to the procedures defined in Clause 4, Article 8 of this Regulation.
2. The inspecting agency shall conduct the re-inspection according to the provisions in Chapter 2.
3. If the establishment is rated Class A or Class B according to the provisions in Clause 3, Article 11, the inspecting agency shall have to send a written document requesting the certifying agency to restore the validity of the certificate granted to the establishment according to the procedures defined at Clauses 1 and 2 of Article 14.
4. After examining the dossiers and proposal of the inspecting agency, the head of the certifying agency shall issue a decision to restore the validity of the certificate already granted to the establishment according to the procedures prescribed in Clause 3, Article 14.
Article 19.- Withdrawal of certificates
1. In the following cases, the head of the inspecting agency shall send a document enclosed with the full dossiers to the certifying agency, requesting the latter to issue a decision to withdraw the certificates already granted to:
a) The establishments which have their certificates invalidated and deliberately failed to meet the inspecting agencies’ requirements on rectifying, overcoming errors regarding the conditions to ensure the FHS within the prescribed time limit;
b) The establishments which have their certificates invalidated for the second time in 12 months;
c) The establishments which have more than 3 consecutive goods lots subject to warning by the competent bodies, but fail to apply effective remedial measures;
d) The establishments which have deliberately committed serious violations or repeated violations of the regulations on the use of granted certificates and code, violated in a systematic manner the law provisions on ensuring the FHS which may seriously affect the consumers’ health;
e) Having clear evidence showing that the inspection results do not accurately reflect the reality on the establishment’s conditions to ensure FHS.
2. The head of the certifying agency shall consider and decide the withdrawal of certificate already granted to the establishment. The decision is made in 5(five) copies: 1 copy is sent to the establishment, 1 to the inspecting agency, 1 to the agency which has issued the decision to set up the establishment or the agency which has granted the production/business license to the establishment, and 1 kept at the certifying agency.
3. The establishment shall have to submit the original of the granted certificate, the certifying agency shall have to stamp "Da thu hoi" (withdrawn) on the certificate and keep the dossier. The withdrawn certificate is no longer valid legally.
4. The procedures for applying for re-granting of the certificate shall comply with those applicable to establishments applying for re-inspection registration as provided for in Clause 2, Article 5 this Regulation.
Chapter IV
RESPONSIBILITIES AND POWERS
Article 20.- Responsibilities of establishments
1. To fully comply with the dossier procedures defined in Article 8 of this Regulation.
2. To create all favorable conditions for inspectors to work at the establishments.
3. To regularly maintain the already recognized FHS conditions.
4. To seriously rectify errors stated in the inspection mininutes.
5. To pay inspection charges and certificate-granting fees as prescribed.
Article 21.- Responsibilities and powers of the central inspecting agency
1. To organize the inspection of the FHS conditions of establishments as assigned in Article 4.
2. To guide establishments as assigned at Article 4 on the regulations, standards and procedures related to ensuring the FHS.
3. To systematically archive all inspection dossiers of establishments; to supply dossiers, to fully and accurately explain the inspection results at the request of establishments or certificate-granting agency.
4. To settle complaints of establishments according to provisions at Chapter 6 of this Regulation within the assigned competence.
5. To elaborate instructions on inspection methods, tables of to be- inspected items; methods of assessment of the extent of errors for each group of to be-inspected items, methods of general assessment of FHS conditions for each type of establishment, inspection forms, and submit them to the Ministry of Aquatic Resources for promulgation and uniform application nationwide.
6. To coordinate with the Aquatic Resource Protection Department in providing professional guidance to local inspecting agencies, to support and coordinate with local inspecting agencies in FHS control activities.
7. Periodically before January 15 and July 15 every year, to sum up FHS control activities of localities and establishments, send written reports thereon to the Ministry of Aquatic Resources and propose measures to better this work.
Article 22.- Responsibilities and powers of local inspecting agencies
1. To perform tasks mentioned in Clauses from 1 to 4 of Article 21, within the scope of management assigned at Article 4.
2. Periodically before the seventh day of the first month of each quarter every year, to send written sum-up reports to the provincial/municipal Aquatic Resources Services (provincial/municipal Agriculture and Rural Development Services managing aquatic resources) and the central inspecting agency on the results of inspection of FHS conditions of establishments under their respective management.
3. To coordinate with Prophylactic Medicine Centers and concerned managerial agencies in their respective localities in guiding and popularizing knowledge about FHS to local people and to urge and examine the observance of regulations by establishments under their respective management.
Article 23.- Responsibilities and powers of inspectors
1. To inspect, consider and assess the compatibility of the current production and trading of aquatic products with the prescribed criteria.
2. To take samples as prescribed for inspection of raw materials, semi-finished products, products as well as additives and chemicals’ used in aquatic food processing.
3. To request the examination of books, documents and dossiers related to the aquatic food quality control, photocopy and take notes of necessary information.
4. To make records on and seal samples for a necessary period of time if there is evidence confirming that establishments have breached this Regulation as well as other State provisions related to ensuring aquatic food hygiene and safety.
5. To report to the heads of inspecting agencies cases which fall beyond their prescribed jurisdiction for the handling thereof.
6. To keep confidential information related production and business secrets of the inspected establishments, to comply with the Ordinance on Inspection and documents related to inspectors.
Article 24.- Responsibilities of the Ministry of Aquatic Resources
1. To uniformly manage the inspection work and the granting of certificates of FHS conditions of establishments engaged in aquatic goods - production and trading nationwide.
2. To grant certificates, suspend the validity of certificates or withdraw certificates according to the provisions of this Regulation.
3. To approve organizations under the system of central and local inspecting agencies.
4. To uniformly direct all professional activities; to control the activities of local inspecting agencies, the central inspecting agency and the local certificate-granting agencies.
5. Periodically on February 1st and August 1st every year, to publicize lists of establishments already granted certificates.
6. To coordinate with concerned ministries, branches and provincial/municipal People’s Committees in organizing the implementation of regulations on ensuring FHS by aquatic food production and business establishments.
Article 25.- Responsibilities of provincial/municipal Aquatic Resources Services, the provincial/municipal Agriculture and Rural Development Services managing aquatic resources
1. To direct, guide and inspect the implementation of this Regulation within the scope of their management as assigned at Clause 3, Article 6.
2. To grant certificates, suspend the validity of certificates or withdraw granted certificates according to the provisions of this Regulation within the scope of their assigned management.
3. To organize and inspect the implementation of the stipulations of the Ministry of Aquatic Resources as well as professional guidance of the central inspecting agency.
4. To organize and build the material and personnel foundations for local inspecting agencies to be capable of inspecting the FHS conditions of aquatic food production and business establishments within their assigned responsibilities.
5. Periodically before January 15 and July 15 every year, to report in writing to the Ministry of Aquatic Resources and the provincial/municipal People’s Committees on the lists of establishments granted certificates in the period, on the certificate granting situation, inspection, supervision and handling of violations within the scope of their assigned responsibilities.
6. To coordinate with the provincial/municipal Health Services and concerned local branches in organizing the implementation of regulations on FHS by aquatic food production and business establishments.
Chapter V
INSPECTION CHARGES AND CERTIFICATE- GRANTING FEES
Article 26.- Charges and fees
1. The inspecting agencies are entitled to collect inspection charges in the cases of: first-time inspection, re-inspection, periodical inspection, verification; to collect fees for granting of certificates. The levels, management and use of charges and fees shall comply with the stipulations and guidance of the Finance Ministry.
2. The inspecting agencies, the certifying agencies and inspectors are strictly forbidden to collect charges and fees in contravention of regulations.
Chapter VI
COMPLAINTS, SETTLEMENT OF COMPLAINTS AND SANCTIONS
Article 27.- Complaints
1. Establishments may complain to the heads of inspecting agencies and/or certifying agencies at all levels about the inspection activities and the granting of certificates.
2. If disagreeing with the conclusions of inspecting agencies or certifying agencies, establishments may complain to the higher-level competent authorities according to the Law on Complaints and Denunciations, which was guided in the Government’s Decree No.67/1999/ND-CP of August 7, 1999.
Article 28.- Settlement of complaints
1. Within 10 days after the receipt of complaints of establishments, the heads of the inspecting agencies or the certifying agencies shall have to consider and settle them within their respective jurisdiction, not in contravention of the Law on Complaints and Denunciations, and have to reply the complainants in writing and report them to the superior agencies for decision.
2. In case of necessity, the heads of the immediate superior bodies of the inspecting agencies or the certifying agencies shall issue decisions to set up inspection teams to consider and reply the establishments in writing.
3. Establishments shall have to pay all the costs of re-inspection or verification if the results of the re-inspection or verification to settle the complaints conform to the results of the previous inspection.
Article 29.- Sanctions
1. All acts of violating this Regulation by establishments, inspecting agencies, certifying agencies or inspectors shall be sanctioned according to law, depending on the seriousness of the violations.
2. All administrative violations shall be sanctioned according to Decree No.57/CP of May 31, 1997 of the Government on administrative sanctions in the field of measurement and goods quality as well as other relevant documents.
3. Violations which cause serious consequences or constitute dangerous recidivism may be examined for penal liability according to law.
Chapter VII
IMPLEMENTATION PROVISIONS
Article 30.- Statute of limitations and amendment of the Regulation
1. This Regulation takes effect 15 days after its signing for promulgation. All previous stipulations contrary to this Regulation are now annulled.

2. Every supplement or amendment to this Regulation shall be considered and decided in writing by the Minister of Aquatic Resources

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Decree No. 88/2023/ND-CP dated December 11, 2023 of the Government amending and supplementing a number of articles of the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy, and the Government’s Decree No. 155/2018/ND-CP of November 12, 2018, amending and supplementing a number of regulations on business investment conditions under the state management of the Ministry of Health

Decree No. 88/2023/ND-CP dated December 11, 2023 of the Government amending and supplementing a number of articles of the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy, and the Government’s Decree No. 155/2018/ND-CP of November 12, 2018, amending and supplementing a number of regulations on business investment conditions under the state management of the Ministry of Health

Food and drug , Investment , Medical - Health

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