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  3. Issuing the sanitary approval/notification for placing on the market of products, materials, chemicals/mixtures and equipment that come into contact with drinking water*

Issuing the sanitary approval/notification for placing on the market of products, materials, chemicals/mixtures and equipment that come into contact with drinking water*

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Procedure
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National

The procedure establishes the steps that must be followed in order to obtain the sanitary approval/notification according to the provisions of Order no. 275 of March 26, 2012 regarding the approval of the sanitary regulation procedure for placing on the market products, materials, chemicals/mixtures, and equipment that come into contact with drinking water. The file is submitted at the headquarters of INSP/CNMRMC, the Regional Centers for Public Health Bucharest, Cluj, Iasi, Targu Mures, Timisoara, and the Environmental Health Sections.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
Request addressed to INSP/CRSP with the applicant's letterhead, address, telephone number, registration number at the trade register (according to the model in Annex no. 1)*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The address where the manufacturer or importer is based in Romania*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The commercial name of the product*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Scope of use/applicability, instructions/conditions of use;*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The standard quantitative and qualitative composition and the CAS (Chemical Abstract Service) numbers of the product, material, chemical substance/mixture or equipment used in contact with drinking water*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The control criteria for the purity of the ingredients or the quality certificate regarding the purity criteria of the ingredients, in copy and in original;*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Safety data sheet of the product, material, chemical substance/mixture or equipment used in contact with drinking water*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration of conformity of the product, material, chemical substance/mixture or equipment used in contact with drinking water.*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The product file must be submitted in Romanian or, as the case may be, with a certified translation.*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The analysis/test reports carried out by accredited laboratories in the field.*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Other documents if applicable*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
Sanitary Approval / Notification for products, materials, chemical substances/mixtures, and equipment that come into contact with drinking water.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Technical evaluation report for products, materials, chemicals/mixtures, and equipment that come into contact with drinking water.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Invoice*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
payment notice*
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:
30
Calendar days
Notification deadline:
5
Calendar days
Appeal routes

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

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
22 January 2024
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 Institute of Public Health*
*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 Institute of Public Health*
Str. Dr. Leonte Anastasievici Nr 1-3
Telefon: 021 318 36 20
Fax: 021 318 36 19
Email: directie.generala@insp.gov.ro
www.insp.gov.ro
Table of contents

Competent entities

Centrul Regional de Sanatate Publica Bucuresti
Centrul Regional de Sanatate Publica Cluj
Centrul Regional de Sanatate Publica Iasi
Centrul Regional de Sanatate Publica Tg. Mures
Centrul Regional de Sanatate Publica Timisoara
Centrul Regional de Sanatate Publica Craiova
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