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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 sanitary veterinary supervision and control and for food safety, 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 Sanitary Veterinary and Food Safety Directorates/the Municipality of Bucharest:

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

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

- sanitary veterinary and food safety laboratories exclusively related to units in the food industry, units producing animal feed, or units for animal husbandry subject to sanitary-veterinary supervision and control and for food safety, organized within 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 to the laboratory's headquarters 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 memorandum*
Descarcă
Scanned document
The technical justification memorandum must include the introductory part, a presentation of the general conditions and the specific operating conditions for each individual laboratory, the list of staff and their responsibilities within the laboratory, the list of matrices, the list of analysis methods, including the list of valid references used within the analysis methods or the standard file for laboratories organized as independent, stand-alone units for the quality control of veterinary medicinal products. The format of the standard file is provided in annex 2 of the Veterinary Sanitary and Food Safety Norm approved by Order of the President of ANSVSA no. 114/2013. In the event that a laboratory resumes the authorization procedure following an order prohibiting its activity, the technical justification memorandum will include, in addition to the elements listed above, a description of how the nonconformities were remedied, including proof of their remediation, 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 apparatus*
Descarcă
Scanned document
Copies of the documents regarding proof of periodic verification of equipment and apparatus carried out by units specially accredited for the calibration of critical equipment and the metrological verification of equipment subject to metrological control will 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 collection and management will be provided.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Laboratory sketch*
Descarcă
Scanned document
On the laboratory sketch, the analytical flows will also be marked, 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, as applicable, will be submitted.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The single registration certificate and the ascertaining certificate*
Descarcă
Scanned document
Copies of these documents issued by the Trade Registry will be transmitted in the case of commercial companies.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Incorporation 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 shall 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 laboratory layout plan 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 under item H of annex no. 1 to the Order of the President of ANSVSA no. 96/2014 regarding the approval of fees applicable in the sanitary-veterinary and food safety field, with subsequent amendments and completions. This fee is paid in advance, for each request for sanitary veterinary and food safety authorization, to the County Sanitary Veterinary and Food Safety Directorate or to the Mun. Bucharest, within whose jurisdiction the laboratory operates. If an authorized laboratory requests authorization for additional laboratory testing and analysis activities, the evaluation fee is reduced by 50%.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The act of ownership/rental of the space*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Environmental agreement of the unit/laboratory*
Descarcă
Scanned document
In the event that 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.*
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 address from the County Inspectorate for Emergency Situations specifying 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

-
Sanitary Veterinary 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 event of a dispute between the beneficiary and the competent authority, the common law provisions shall apply.

*
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*
Bucureşti, Piaţa Presei Libere nr. 1, Corp D1, Sector 1, Cod Poştal 013701
Telefon: 0372184977
Fax: 0372184993
Email: office@ansvsa.ro
www.ansvsa.ro
Table of contents

Competent entities

Direcţia Coordonare Laboratoare şi Produse Medicinale Veterinare - ANSVSA

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