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RTF Template

French Agency for veterinary medicinal products - French Agency for food, environmental and occupational health safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products

1. Authorisation Number	:	V 158609/19
2. Name of Authorisation Holder	:	Cooperative D'Exploitation Et De Repartition Pharmaceutique De Bretagne Atlantique (ORG-100025167 / LOC-100054693)
2.a. Alternative name of authorisation holder (optional)	:	CERP Bretagne Atlantique
3. Address(es) of Site(s)	:	Zac De La Malterie Ii, 2 Avenue Pierre Clostermann, Montierchaume, 36130, France

4. Legally registered address of Authorisation Holder	:	Zone Industrielle Legere, 22 Rue Chaptal, St Brieuc, 22000
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	:	2016-11-04
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: Cooperative D'Exploitation Et De Repartition Pharmaceutique De Bretagne Atlantique

(ORG-100025167 / LOC-100054694)

, Zac De La Malterie Ii, 2 Avenue Pierre Clostermann, Montierchaume, 36130, France

Veterinary medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

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

*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 158609/19
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