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RTF Template

National Agency For The Safety Of Medicine And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	2022_096_1_3
2. Name of Authorisation Holder	:	Laboratoire Renaudin (ORG-100004474 / LOC-100000616)
3. Address(es) of Site(s)	:	Zone Artisanale Errobi, Itxassou, 64250, France

4. Legally registered address of Authorisation Holder	:	Zone Artisanale Errobi, Itxassou, 64250
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2022-07-12
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: Laboratoire Renaudin

(ORG-100004474 / LOC-100000616)

, Zone Artisanale Errobi, Itxassou, 64250, France

Human 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

2.2. Holding

2.3. Supply

2.4. Export

2.5. Other activities(s): Exploitation

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

Any restrictions or clarifying remarks (for all users): -
Exploitant (Public Health Code Article R.5124-2 3°)
"Exploitation" of medicinal products other than investigational medicinal products, generators, kits and precursors (Article L.4211-1 3 °): wholesale and distribution free of charge, advertising, information, pharmacovigilance, batch follow-up and recall; may concern all or part of the medicinal products with additional requirements.
Only storage is limited to the categories mentioned in 3.

Signatory: Mrs Mélanie Cachet, deputy director - Inspection division
The ANSM does not issue hard copy of this authorisation.
----

Etablissement exploitant (code de la santé publique art. R.5124-2 3°)
Exploitation de médicaments autres que les médicaments expérimentaux, de générateurs, trousses et précurseurs (art. L.4211-1 3°) : vente en gros ou cession à titre gratuit, publicité, information, pharmacovigilance, suivi et retrait des lots; peut concerner tout ou partie des médicaments ayant des exigences particulières.
Seul le stockage est limité aux catégories citées en 3.

Signataire : Mme Mélanie Cachet, directrice adjointe - Direction de l'inspection
L'ANSM ne délivre pas de copie papier de cette autorisation.

*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	2022_096_1_3
	Page 1

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