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RTF Template

National Veterinary Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products

1. Authorisation Number	:	V 274990/20
2. Name of Authorisation Holder	:	Domes Pharma (ORG-100004410 / LOC-100005659)
3. Address(es) of Site(s)	:	3 Rue Andre Citroen, Pont-Du-Chateau, 63430, France

4. Legally registered address of Authorisation Holder	:	3 Rue Andre Citroen, Pont-Du-Chateau, 63430
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	:	2020-12-22
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: Domes Pharma

(ORG-100004410 / LOC-100005659)

, 3 Rue Andre Citroen, Pont-Du-Chateau, 63430, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.4. Other products: Veterinary medicinal products as subject to veterinary prescription Médicaments vétérinaires soumis à prescription vétérinaire

Any restrictions or clarifying remarks (for all users): The veterinary medicinal products for which DOMES PHARMA is the owner are only supplied to authorized wholesalers distributors according to article 99 of the regulation (EU) 2019/6.
Veterinary medicinal products for which DOMES PHARMA is not the owner and only ensures storage, can be supplied to persons authorized to carry out retail activities in a Member State in accordance with Article 103 of the regulation (EU) 2019/6.

Les médicaments vétérinaires pour lesquels DOMES PHARMA est propriétaire sont uniquement distribués aux distributeurs en gros autorisés au titre de l'article 99 du règlement (UE) 2019/6.
Les médicaments vétérinaires pour lesquels DOMES PHARMA n'est pas propriétaire et n'assure que le stockage, peuvent être distribués aux personnes autorisées à exercer des activités de commerce au détail dans un état membre conformément à l'article 103 du règlement (UE) 2019/6.

*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 274990/20
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