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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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Indigenous producers of reagents/diagnostic kits for veterinary use can manufacture these products only after obtaining the manufacturing authorization issued by the Institute for 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 issuance.

Any modification of the documentation on the basis of which the manufacturing authorization was issued must be notified within 30 calendar days to the Institute for Control of Biological Products and Veterinary Medicines in order to update 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 NACE code*
Descarcă
Scanned document
Of course! Please provide the Romanian text you want me to translate to English.*
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
Certificate of status issued by the trade registry office*
Descarcă
Scanned document
Original*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The articles of association of the commercial company*
Descarcă
Scanned document
Legalized copy*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of ownership of the space*
Descarcă
Scanned document
Ownership deed or rental contract, in notarized copy*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Unit outline*
Descarcă
Scanned document
Desigur, voi traduce textul din română în engleză, respectând cerințele (fără a modifica tagurile HTML și fără a adăuga nimic). Vă rog să trimiteți textul pe care doriți să îl traduc.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Technical justification memorandum*
Descarcă
Scanned document
Desigur, vă rog să furnizați textul în limba română pe care doriți să îl traduc în engleză.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
List of specialized personnel*
Descarcă
Scanned document
Desigur! Te rog să îmi furnizezi textul în limba română pe care dorești să îl traduc.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
List of veterinary diagnostic kits and reagents manufactured in the unit*
Descarcă
Scanned document
Desigur, te rog să furnizezi textul în limba română pe care dorești să îl traduc în engleză.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Description of the manufacturing flow*
Descarcă
Scanned document
Of course! Please provide the Romanian text you'd like me to translate into English.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Producer's own responsibility declaration regarding the manufacture of reagents and diagnostic kits for veterinary use in conditions that ensure the quality of these products*
Descarcă
Scanned document
Desigur, te rog, scrie textul în limba română pe care dorești să îl traduc.*
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
There is no Romanian text to translate in your message. Please provide the Romanian text you want translated into English.*
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 case of litigation, between the competent authorities and the beneficiary who considers themselves harmed in a right of theirs or in a legitimate interest, by ICBMV through an administrative act or by failing to resolve a request within the legal deadline, they may address the competent administrative litigation court under the conditions established by the 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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