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RTF Template

French National Agency for Medicines and Health Products Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	FD 18/106
2. Name of Authorisation Holder	:	ROVI
3. Address(es) of Site(s)	:	24 Rue du Drac, SEYSSINS, 38180, France

4. Legally registered address of Authorisation Holder	:	24 Rue du Drac, SEYSSINS, 38180, France
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2018-05-25
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: ROVI

, 24 Rue du Drac, SEYSSINS, 38180, France

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

2.3. Supply

2.4. Export

2.5. Other activities(s): exploitation

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 : 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.

Signatory: Mrs Mélanie Cachet, head of pharmaceutical product inspection and counterfeiting fight department
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 : 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.

Signataire: Mme Mélanie Cachet, chef du Pôle inspection des produits pharmaceutiques et lutte contre les fraudes
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	FD 18/106
	Page 1

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