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RTF Template

Landesamt Fuer Soziales Jugend Und Versorgung

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_RP_01_WDA_2017_54.4/167-222
2. Name of Authorisation Holder	:	medelo Michael Longen e.K. (ORG-100039629 / LOC-100062691)
3. Address(es) of Site(s)	:	Gewerbegebiet 34, Kenn, Rhineland-Palatinate, 54344, Germany

4. Legally registered address of Authorisation Holder	:	Gewerbegebiet 34, Kenn, Rhineland-Palatinate, 54344
5. Scope of authorisation	:	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 wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2017-06-07
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: medelo Michael Longen e.K.

(ORG-100039629 / LOC-100062691)

, Gewerbegebiet 34, Kenn, Rhineland-Palatinate, 54344, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal Gases: only oxygen Medizinische Gase: nur Sauerstoff

Any restrictions or clarifying remarks (for all users): ref. 1.1: Only skin and hand disinfectants and infusion solutions regulated in section 47 subsection 1 number 2c Medicinal Products Act (Arzneimittelgesetz)
ref. 2.1 and 2.3: Supply (partially) by drop shipment

zu 1.1: Nur Haut- und Händedesinfektionsmittel und Infusionslösungen gemäß § 47 Abs. 1 Nr. 2c Arzneimittelgesetz
zu 2.1 und 2.3: Handel erfolgt (teilweise) im Streckengeschäft

Union Format for a Wholesale Distribution Authorisation	DE_RP_01_WDA_2017_54.4/167-222
	Page 1

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