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Procedure regarding the issuance of the certificate of pharmaceutical product required for the export of veterinary medicinal products to third countries*

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Procedure
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The export of veterinary medicinal products to third countries may be carried out on the basis of the pharmaceutical certificate of the veterinary medicinal product issued by the specialized structure within the National Sanitary Veterinary and Food Safety Authority.

At the request of the manufacturer/exporter of veterinary medicinal products or of the authorities of an importing third country, ANSVSA certifies that the manufacturer holds a manufacturing authorization, by issuing a certificate the model of which is provided in Annex no. 21 or a certificate whose format is established by the authorities of an importing third country, in accordance with that recommended by the World Health Organization.

If the manufacturer does not hold a marketing authorization, they must provide the National Sanitary Veterinary and Food Safety Authority with a statement explaining why they do not have this authorization.

The pharmaceutical certificate of the veterinary medicinal product is issued for a single veterinary medicinal product.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
Request*
Descarcă
Scanned document
It will include the name, address of the applicant, name of the veterinary medicinal product/products and the estimated quantity to be exported as well as the name of the importing country;*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Valid marketing authorization in Romania;*
Descarcă
Scanned document
A copy will be transmitted, as applicable*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Written statement to justify the absence of marketing authorization, if applicable*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Manufacturing authorization and certificate for compliance with good manufacturing practices, in the case of manufacturers outside Romania*
Descarcă
Scanned document
A copy of the manufacturing authorization and a copy of the valid certificate of compliance with good manufacturing practices, in the case of manufacturers outside Romania*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Summary of product characteristics in Romanian and English that must be in accordance with the marketing authorization.*
Descarcă
Scanned document
A copy of the summary of product characteristics in Romanian and English, which must be consistent with the marketing authorization, will be provided. The applicant assumes full responsibility for the accuracy of the translation of the text from Romanian into English.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The model of the export certificate requested by the importing country, if applicable*
Descarcă
Scanned document
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of payment of the fee provided by the veterinary sanitary legislation in force*
Descarcă
Scanned document
A copy of the document attesting the payment of the fee provided in Annex no. 6 C to Order A.N.S.V.S.A. no. 96/2014 regarding the approval of fees applicable in the veterinary sanitary and food safety field, with subsequent amendments and additions, will be submitted.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
Certificate of Pharmaceutical Product*
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:
5
Calendar days
Appeal routes

If the economic operators are dissatisfied with the result of the request, they may lodge an appeal within the deadlines and conditions provided by Law no. 554/2004 on administrative litigation, with subsequent amendments and additions.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
14 March 2025
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
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Competent entities

Direcţia Coordonare Laboratoare şi Produse Medicinale Veterinare - ANSVSA

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