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  3. Procedure for obtaining the Manufacturing Authorization for reagents/diagnostic kits for veterinary use*

Procedure for obtaining the Manufacturing Authorization for reagents/diagnostic kits for veterinary use*

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Procedure
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Companii
National

Indigenous manufacturers of reagents/diagnostic kits for veterinary use may manufacture these products only after obtaining the manufacturing authorization issued by the Institute for the Control of Biological Products and Veterinary Medicines. The manufacturing authorization is issued for each reagent and diagnostic kit for veterinary use and is valid for 5 years from the date of issue.

Any modification of the documentation based on which the manufacturing authorization was issued must be notified within 30 calendar days to the Institute for the Control of Biological Products and Veterinary Medicines for the purpose of updating the manufacturing authorization.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
The request from the legal entity, specifying the activities and the CAEN code*
Descarcă
Scanned document
*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificate of registration issued by the trade register office*
Descarcă
Scanned document
Copy*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The certificate issued by the trade register office*
Descarcă
Scanned document
Original*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The articles of incorporation of the commercial company*
Descarcă
Scanned document
Legalized copy*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of space ownership*
Descarcă
Scanned document
Deed of ownership or lease contract, in a certified copy*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Outline of the unit*
Descarcă
Scanned document
*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The technical justification memorandum*
Descarcă
Scanned document
*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The list of specialist staff*
Descarcă
Scanned document
(empty)*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
List of veterinary diagnostic kits and reagents manufactured in the unit*
Descarcă
Scanned document
*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Description of the manufacturing process*
Descarcă
Scanned document
*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility of the producer regarding the manufacture of reagents and veterinary diagnostic kits under conditions that ensure the quality of these products*
Descarcă
Scanned document
*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of payment of the evaluation fee for obtaining the manufacturing authorization*
Descarcă
Scanned document
*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
Manufacturing authorization*
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:
5
Calendar days
Notification deadline:
2
Calendar days
Appeal routes

In the event of a dispute between the competent authorities and the beneficiary who considers themselves harmed in a right or a legitimate interest, by the ICBMV through an administrative act or by failing to resolve a request within the legal term, they may address the competent administrative court under the conditions established by Administrative Litigation Law no. 554/2004.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
20 November 2019
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.
Institute for the Control of Biological Products and Veterinary Medicines Icbmv*
*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.
Institute for the Control of Biological Products and Veterinary Medicines Icbmv*
Str. Dudului 39
Telefon: 0212202112
Fax: 0212213171
Email: icbmv@icbmv.ro
www.icbmv.ro
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Control și Evaluare Seturi de Diagnostic și Reagenți
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