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RTF Template


National Veterinary Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products


1. Authorisation Number

:

V 356518/24

2. Name of Authorisation Holder

:

Nextmune

(ORG-100051325 / LOC-100089906)

3. Address(es) of Site(s)

:

Zone D Activite Le Causse-Espace Entreprises, Castres, 81100, France 




4. Legally registered address of Authorisation Holder

:

Zone D Activite Le Causse-Espace Entreprises, Castres, 81100, 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

:

2024-07-05

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: Nextmune

(ORG-100051325 / LOC-100089906)

, Zone D Activite Le Causse-Espace Entreprises, Castres, 81100, 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 

   2.3. Supply 

   2.5. Other activities(s): responsible for marketing authorisation, advertising, info, pharmaco, follow-up and produc recallresponsable de la mise sur le marché, publicité, info, pharmaco, suivi et retrait des lots



Any restrictions or clarifying remarks (for all users):  Veterinary medicinal products distributed are only those for which NEXTMUNE is responsible for marketing
authorisation under Article 58 of Regulation (EU) 2019/6. Storage operations are carried out within the site
SERVIPHAR, PARC D'ACTIVITES DU HAUT MONTIGNE, 616 RUE DU PONT SAMOUAL, 35370 TORCE.

Les médicaments vétérinaires distribués sont uniquement ceux pour lesquels NEXTMUNE est responsable
de la mise sur le marché au titre de l'article 58 du règlement (EU) 2019/6. Les opérations de stockage sont
réalisées au sein de l'établissement SERVIPHAR, PARC D'ACTIVITES DU HAUT MONTIGNE, 616 RUE
DU PONT SAMOUAL, 35370 TORCE.



*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 356518/24


Page 1





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