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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	:	MD 16/055
2. Name of Authorisation Holder	:	UBIPHARM-MARTINIQUE
3. Address(es) of Site(s)	:	1490 Chemin du Glycéria, Lotissement Plateau Acajou, LE LAMENTIN (MARTINIQUE), 97232, France

4. Legally registered address of Authorisation Holder	:	1490 Chemin du Glycéria, Lotissement Plateau Acajou, LE LAMENTIN (MARTINIQUE), 97232, 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	:	2016-02-17
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: UBIPHARM-MARTINIQUE - LE LAMENTIN (MARTINIQUE)

, 1490 Chemin du Glycéria, Lotissement Plateau Acajou, LE LAMENTIN (MARTINIQUE), 97232, 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

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.2. Medicinal gases

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): This site is authorized as a "dépositaire". 1.1 : the activity is undertaken by order and on behalf of an "exploitant". 1.2 : medicinal products with temporary authorization for use, dressing objects or articles presented as complying with the Pharmacopoeia or pharmacy-repackaged products.This site is authorized as a wholesale distributor. The wholesale distributor shall not export medicinal products when acting by order and on behalf of license1.2 :

Cet établissement est dépositaire. 1.1 : l'activité est exercée d'ordre et pour le compte d'un exploitant. 1.2 : médicaments sous autorisation temporaire d'utilisation, objets de pansement ou articles présentés comme conformes à la Pharmacopée ou de produits officinaux divisés.Cet établissement est grossiste-répartiteur. Le grossiste-répartiteur ne doit pas distribuer de médicaments en dehors du territoire national quand il agit d'ordre et pour le compte de pharmaciens titulaires d'officine ou de structures mentionnées à l'article D. 5125-24-16.

*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	MD 16/055
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