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RTF Template

State Institute For Drug Control

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	sukls214839/2025
2. Name of Authorisation Holder	:	Berlin-Chemie/A.Menarini Ceska republika s.r.o. (ORG-100010141 / LOC-100015164)
3. Address(es) of Site(s)	:	K Perovne 945/7, Hostivar, Prague, 102 00, Czechia

4. Legally registered address of Authorisation Holder	:	Budejovicka 778/3, Michle, Prague, 140 00
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	:	2025-06-16
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: Berlin-Chemie/A.Menarini Ceska republika s.r.o.

(ORG-100010141 / LOC-100063077)

, K Perovne 945/7, Hostivar, Prague, 102 00, Czechia

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

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Union Format for a Wholesale Distribution Authorisation	sukls214839/2025
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