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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
Online
Companii
National

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 Directorates for Veterinary Sanitary and Food Safety/of Bucharest Municipality:

- laboratories that carry out as their sole activity the detection of the presence of Trichinella in muscle tissue, in accordance with Commission Implementing Regulation (EU) 2015/1375 of 10 August 2015 laying down specific rules on official controls for the presence of Trichinella in meat, with subsequent amendments;

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

- veterinary sanitary and food safety laboratories exclusively related to units in the food industry, pet food production units or animal breeding units subject to veterinary sanitary and food safety supervision and control, organized in units where testing and laboratory analysis activities are carried out, also known as factory laboratories.

​When the authorization file is complete, the applicant will be notified about the visit of the Evaluation Commission at the laboratory's premises for verifying the general and specific operating conditions, as well as for completing the evaluation sheet and the evaluation report.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
Technical Justification Report*
Descarcă
Scanned document
The justificatory technical memorandum must contain the introductory part, the presentation of general conditions and specific operating conditions for each individual laboratory, the list of personnel and their responsibilities within the laboratory, the list of matrices, the list of analysis methods, including the list of current reference standards used within the analysis methods or the standard file for laboratories organized as independent, standalone units for quality control of veterinary medicinal products. The format of the standard file is provided in Annex 2 of the Veterinary Sanitary and Food Safety Regulation approved by Order of the ANSVSA President No. 114/2013. In case a laboratory resumes the authorization procedure following a prohibition order, the justificatory technical memorandum will include, in addition to the elements listed above, a description of how the non-conformities were remedied, including proof of remedy, where applicable.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
List of available equipment*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Documents regarding the verification of equipment and devices*
Descarcă
Scanned document
Copies of documents regarding proof of periodic verification of equipment and devices carried out by specially accredited units for the calibration of critical equipment and the metrological verification of equipment subject to metrological control shall be submitted.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Documents regarding waste management*
Descarcă
Scanned document
Copies of the contracts with companies specialized in waste removal and management will be submitted.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Laboratory outline*
Descarcă
Scanned document
The laboratory diagram will also mark the analytical flows, in detail.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificate of Fiscal Registration*
Descarcă
Scanned document
A copy of the tax registration certificate issued by ANAF for VAT purposes, if applicable, will be provided.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The unique registration certificate and the ascertaining certificate*
Descarcă
Scanned document
Copies of these documents issued by the Trade Register will be provided in the case of commercial companies.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The founding document*
Descarcă
Scanned document
A copy of the court decision of establishment, the registration certificate 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.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The layout plan of the laboratory within the unit*
Descarcă
Scanned document
It is necessary when the analysis laboratory is part of a unit that also carries out other activities.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of payment of the evaluation fee*
Descarcă
Scanned document
The evaluation fee is provided for in letter H of Annex no. 1 to the Order of the President of ANSVSA no. 96/2014 regarding the approval of the fees applicable in the sanitary-veterinary and food safety field, with subsequent amendments and completions. This fee is paid in advance, for each application for sanitary-veterinary and food safety authorization, to the County Veterinary Sanitary and Food Safety Directorate, or to that of the Municipality of Bucharest, 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%.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The deed of ownership/rental of the space*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The environmental agreement of the unit/laboratory*
Descarcă
Scanned document
In case the agreement is not necessary, a copy of the letter from the county authority in the field of environmental protection specifying this will be sent.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
ISU agreement for unit/laboratory*
Descarcă
Scanned document
In case the agreement is not necessary, a copy of the letter from the County Inspectorate for Emergency Situations stating this will be sent.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The authorization request*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
Veterinary Sanitary Authorization and for Food Safety*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține 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: 0372184943
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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