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RTF Template

State Agency Of Medicines

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	L00108
2. Name of Authorisation Holder	:	Berlin-Chemie/Menarini Baltic SIA (ORG-100011070 / LOC-100017002)
3. Address(es) of Site(s)	:	Bauskas Iela 58a, Riga, 1004, Latvia

4. Legally registered address of Authorisation Holder	:	Bauskas Iela 58a, Riga, 1004
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 40 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	:	2025-09-19
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/Menarini Baltic SIA

(ORG-100011070 / LOC-100017002)

, Bauskas Iela 58a, Riga, 1004, Latvia

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

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) 3.1.1. psychotropic medicinal products

Any restrictions or clarifying remarks (for all users): 3.1.1. psychotropic medicinal products

1) holding of medicinal products in Noliktavu iela 5, Dreiliņi, Stopiņu pagasts, Ropažu novads, LV-2130, Latvia (site of contract wholesale distribution Sabiedrība ar ierobežotu atbildību "Tamro", number of authorisation Nr.L00019)
2) Annex 1 Paragraph 3.2. – except psychotropic medicinal products

3) holding of medicinal products in Noliktavu iela 5, Dreiliņi, Stopiņu pagasts, Ropažu novads, LV-2130, Latvia (site of contract wholesale distribution Sabiedrība ar ierobežotu atbildību "Tamro", number of authorisation Nr.L00019).

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	L00108
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