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  3. Authorization of laboratories where activities subject to sanitary-veterinary supervision and control and for food safety are carried out*

Authorization of laboratories where activities subject to sanitary-veterinary supervision and control and for food safety are carried out*

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Procedure
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Details

The procedure applies to laboratories subject to veterinary sanitary and food safety supervision and control where testing and laboratory analysis activities are carried out, for obtaining the operating authorization from the National Sanitary Veterinary and Food Safety Authority (ANSVSA).

The following categories of laboratories are authorized by the County/Municipality of Bucharest Veterinary and Food Safety Directorates:

- laboratories whose sole activity is the detection of Trichinella presence in muscle tissue, in accordance with Commission Implementing Regulation (EU) 2015/1.375 of 10 August 2015 laying down specific rules applicable to official controls regarding the presence of Trichinella in meat, as subsequently amended;

- laboratories organized within professional associations and foundations in the agri-food sector subject to veterinary sanitary and food safety supervision and control where testing and laboratory analysis activities are carried out;

- veterinary sanitary and food safety laboratories pertaining exclusively to units in the food industry, animal feed manufacturers, or animal breeding units subject to veterinary sanitary and food safety supervision and control, organized within units where testing and laboratory analysis activities are carried out, also known as in-house laboratories.

​When the authorization file is complete, the applicant will be notified about the evaluation commission's visit to the laboratory's headquarters for the verification of general and specific operating conditions, as well as for completing the evaluation sheet and the evaluation report.

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Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
Technical justificatory memorandum*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
The technical justification memorandum must contain the introductory section, the presentation of general conditions and specific operating conditions for each individual laboratory, the staff list and their duties within the laboratory, the list of matrices, the list of analysis methods, including the list of currently applicable reference standards used in the analysis methods, or the standard file for laboratories organized as independent, stand-alone units for the quality control of veterinary medicinal products. The standard file format is provided in annex 2 of the Veterinary and Food Safety Sanitary Norm approved by Order of the ANSVSA President no. 114/2013. In the event that a laboratory resumes the authorization procedure following an order prohibiting its activity, the technical justification memorandum will contain, in addition to the elements listed above, a description of how the non-conformities have been remedied, including proof of remediation, where applicable.*
List of equipment available*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Documents regarding the inspection of equipment and devices*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Copies of the documents proving the periodic verification of equipment and devices performed by specially accredited units for the calibration of critical equipment and the metrological verification of equipment subject to metrological control will be submitted.*
Documents regarding waste management*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Copies of contracts with companies specialized in waste collection and management will be submitted.*
Laboratory outline*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
On the laboratory sketch, the analytical flows will also be marked, in detail.*
Tax Registration Certificate*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
The copy of the tax registration certificate issued by ANAF for VAT purposes, as applicable, will be transmitted.*
The unique registration certificate and the certificate of findings*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Copies of these documents issued by the Trade Registry will be transmitted in the case of commercial companies.*
The incorporation document*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
A copy of the court decision of establishment, the certificate of registration in the register of associations and foundations, and the statute will be transmitted in the case of professional associations and foundations in the agri-food sector.*
The location plan of the laboratory within the unit*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
It is necessary when the analysis laboratory is part of a unit that also carries out other activities.*
Proof of payment of the evaluation fee*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
The evaluation fee is provided for in point H of annex no. 1 to the Order of the ANSVSA President no. 96/2014 regarding the approval of tariffs applicable in the veterinary and food safety field, with subsequent amendments and completions. This fee is paid in advance, for each request for veterinary and food safety authorization, to the County Veterinary and Food Safety Directorate, or to the Bucharest Municipality Directorate, within whose jurisdiction the laboratory operates. If an authorized laboratory requests authorization for additional testing and laboratory analysis activities, the evaluation fee is reduced by 50%.*
The document of ownership/rental of the space*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Environmental agreement of the unit/laboratory*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
In the case where the agreement is not necessary, a copy of the letter from the county authority in the field of environmental protection stating this will be sent.*
The ISU approval for the unit/laboratory*
Descarcă
Scanned document
 obligatoriu cu semnatură digitală disponibil și prin OOTS
In case the agreement is not necessary, a copy of the letter from the County Inspectorate for Emergency Situations specifying this will be sent.*
The authorization request*
Descarcă
Formular tipizat
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
Sanitary Veterinary and Food Safety Authorization*
 obligatoriu cu semnatură digitală disponibil și prin OOTS
Fees

Title

Payment method

Value

Currency

None
Deadlines
Resolution time:
30
Calendar days
Case filling duration:
15
Calendar days
Notification deadline:
7
Calendar days
Appeal routes

In the case of a dispute between the beneficiary and the competent authority, the provisions of common law are applicable.

*
Additional information
More info:
Links
Assistance and problem-solving services
None
Last updated: 
08 September 2022
Publicat de către: 
A paragraph is a self-contained unit of a discourse in writing dealing with a particular point or idea. Paragraphs are usually an expected part of formal writing, used to organize longer prose.
Institution responsible with document: 
Publicat de către: 
A paragraph is a self-contained unit of a discourse in writing dealing with a particular point or idea. Paragraphs are usually an expected part of formal writing, used to organize longer prose.
National Sanitary Veterinary and Food Safety Authority*
*Content marked with an asterisk (*) has been automatically translated and may not fully reflect the original meaning. For objective interpretation, please consult the Romanian version.
National Sanitary Veterinary and Food Safety Authority*
Piaţa Presei Libere nr. 1, Clădirea nr. Corp D1, Sector 1, RO
Telefon: 0372184977
Fax: 0372184993
Email: office@ansvsa.ro
www.ansvsa.ro
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Direcţia Coordonare Laboratoare şi Produse Medicinale Veterinare - ANSVSA
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