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RTF Template

Landesamt Fuer Gesundheit Und Soziales

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BE_01_WDA_2024_5373/1 - Medios Pharma GmbH/09
2. Name of Authorisation Holder	:	Medios Pharma GmbH
3. Address(es) of Site(s)	:	Reuchlinstrasse 10-11, Moabit, Berlin, 10553, Germany

4. Legally registered address of Authorisation Holder	:	Reuchlinstr. 10-11, Berlin, 10553, Germany
4.a. Additional details on units inspected of registrant's legal address (optional)	:	HRB 168030 B
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	§ 52a (1) Arzneimittelgesetz AMG (Medicinal Products Act)
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-08-28
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: Medios Pharma GmbH

(ORG-100034996 / LOC-100055490)

, Reuchlinstrasse 10-11, Moabit, Berlin, 10553, Germany

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

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): This authorisation is based on floor plans 1 and 2 from 2023-05-16 and 2024-07-18.
Storage of medicinal products also occurs in contracted facilities.

1.2: In case of medicinal products without authorisation in scope of German Medicinal Products Act only activities according to § 73 (3) Medical Products Act on behalf of pharmacies. These medicinal products are stored intermediatly at this site only and are procured from EU-countries or MRA-states.

Diese Erlaubnis basiert auf den Grundrissplänen 1 und 2 mit Datum vom 16.05.2023 und 18.07.2024
Die Lagerung von Arzneimitteln erfolgt auch in beauftragten Betrieben.

Zu 1.2: Bei Arzneimitteln ohne Zulassung im Geltungsbereich des AMG ausschließlich Tätigkeiten gemäß § 73 Abs. 3 AMG im Auftrag von Apotheken. Diese Arzneimittel werden ausschließlich in dieser Betriebsstätte zwischengelagert und aus EU-Ländern verbracht oder aus MRA-Staaten eingeführt.

*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_BE_01_WDA_2024_5373/1 - Medios Pharma GmbH/09
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