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RTF Template

Regierungspraesidium Tuebingen

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BW_01_WDA_2026_0001_Altatec
2. Name of Authorisation Holder	:	ALTATEC GmbH (ORG-100043451 / LOC-100071878)
3. Address(es) of Site(s)	:	Maybachstraße 5, Wimsheim, Baden-Württemberg, 71299, Germany

4. Legally registered address of Authorisation Holder	:	Maybachstraße 5, Wimsheim, Baden-Württemberg, 71299
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	:	2026-02-17
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: ALTATEC GmbH

(ORG-100043451 / LOC-100071878)

, Maybachstraße 5, Wimsheim, Baden-Württemberg, 71299, 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

2.4. Export

Any restrictions or clarifying remarks (for all users): 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS
3.1. Products according to Art. 83 of 2001/83/EC **

The authorization is limited to the products "MinerOss A Human bone allograft, lyophilized C+TBA"
in various dosage sizes.

3. ARZNEIMITTEL MIT BESONDEREN ANFORDERUNGEN
3.1 Arzneimittel entsprechend Art. 83 der Richtlinie 2001/83/EG

Die Erlaubnis beschränkt sich auf die Produkte „MinerOss A Human bone allograft, lyophilized C+TBA" in verschiedenen Darreichungsgrößen.

*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_BW_01_WDA_2026_0001_Altatec
	Page 1

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