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RTF Template

Landesamt für Soziales, Jugend und Versorgung

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_RP_01_WDA_2020_54.4/GDP/221/2
2. Name of Authorisation Holder	:	BR-melatec GmbH
3. Address(es) of Site(s)	:	Engelstraße 32, Trier, Rhineland-Palatinate, 54292, Germany

4. Legally registered address of Authorisation Holder	:	Engelstraße 32, Trier, Rhineland-Palatinate, 54292, Germany
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	:	2020-07-16
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: BR-melatec GmbH

, Engelstraße 32, Trier, Rhineland-Palatinate, 54292, Germany

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

Any restrictions or clarifying remarks (for all users): Trading only with: Infusion solution 500ml or above, Skin- and Hand- desinfectant, medical Oxygen

Handel nur mit: Infusionslösungen ab 500ml, Haut- und Händedesinfektion, medizinischer Sauerstoff

*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	DE_RP_01_WDA_2020_54.4/GDP/221/2
	Page 1

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