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RTF Template

National Veterinary Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products

1. Authorisation Number	:	V 378399/25
2. Name of Authorisation Holder	:	Laphal Industries (ORG-100002284 / LOC-100010186)
3. Address(es) of Site(s)	:	Avenue De Provence, Allauch, 13190, France

4. Legally registered address of Authorisation Holder	:	Avenue De Provence, Allauch, 13190
5. Scope of authorisation	:	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 wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-04-23
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: Laphal Industries

(ORG-100002284 / LOC-100010186)

, Avenue De Provence, Allauch, 13190, France

Veterinary medicinal products

1. MEDICINAL PRODUCTS

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

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

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) -25°C to -15°C -25°C à -15°C

3.3. Other products: (please specify here or make a reference to Annex 5) Veterinary investigational Médicaments vétérinaires soumis à des essais cliniques

Any restrictions or clarifying remarks (for all users): LAPHAL INDUSTRIES realises storage of veterinary medicinal products on behalf of others wholesale
distributors of veterinary medicinal products and storage of veterinary investigational medicinal products on behalf
of promoters.

LAPHAL INDUSTRIES assure le stockage des médicaments vétérinaires pour le compte d'autres distributeurs en
gros de médicaments vétérinaires et le stockage des médicaments vétérinaires soumis à des essais cliniques pour
le compte de promoteurs.

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Union Format for a Wholesale Distribution Authorisation	V 378399/25
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