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RTF Template


National Veterinary Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products


1. Authorisation Number

:

V 0505/07

2. Name of Authorisation Holder

:

Agrobiothers Laboratoire

(ORG-100034477 / LOC-100054621)

3. Address(es) of Site(s)

:

321 Route Des Platieres, Cuisery, 71290, France 




4. Legally registered address of Authorisation Holder

:

321 Route Des Platieres, Cuisery, 71290, France

5. Scope of authorisation (complete for each site under 4)

:

ANNEX 1

6. Legal basis of authorisation

:

Art. 99 of Regulation (EU) 2019/6

7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2008-11-06

10. Annexes attached

:

Annex 1 Scope of wholesale distribution authorisation

Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number

Annex 3 (Optional) Name(s) of responsible person(s)

Annex 4 (Optional) Date of Inspection on which authorisation was granted

Annex 5 (Optional) Additional provisions based on national requirements


ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION



Name and address of the site: Agrobiothers Laboratoire

(ORG-100034477 / LOC-100054621)

, 321 Route Des Platieres, Cuisery, 71290, France   



Veterinary medicinal products


1. MEDICINAL PRODUCTS

   1.1. with a Marketing Authorisation in EEA country(s)


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 

   2.5. Other activities(s): responsible for marketing authorisation,advertising,information,pharmacov,follow up&product recallresponsable de mise sur le marché,publicité,information,pharmacov,suivi&retrait ds lots



Any restrictions or clarifying remarks (for all users):  Veterinary medicinal products distributed are only those for which AGROBIOTHERS LABORATOIRE is responsible for marketing authorisation under Article 58 of Regulation (EU) 2019/6.
Veterinary medicinal products distributed only concern anti-parasitic veterinary medicinal products for external use for pets.

Les médicaments vétérinaires distribués sont uniquement ceux pour lesquels AGROBIOTHERS LABORATOIRE est responsable de la mise sur le marché au titre de l'article 58 du règlement (EU) 2019/6.
Les médicaments vétérinaires distribués concernent uniquement les médicaments vétérinaires
anti-parasitaires destinés au traitement externe des animaux de compagnie.



*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation













Union Format for a Wholesale Distribution Authorisation

V 0505/07


Page 1





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