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RTF Template

State Agency Of Medicines

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	L00135
2. Name of Authorisation Holder	:	Delfield Baltia SIA (ORG-100041250 / LOC-100094658)
3. Address(es) of Site(s)	:	Lastadijas Iela 42-8, Riga, LV-1050, Latvia

4. Legally registered address of Authorisation Holder	:	Lastadijas Iela 42-11, Riga, LV-1050, Latvia
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	:	2025-01-21
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: Delfield Baltia SIA

(ORG-100041250 / LOC-100094901)

, Lastadijas Iela 42-8, Riga, LV-1050, Latvia

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

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) immunological medicinal products

Any restrictions or clarifying remarks (for all users): holding of medicinal products in Ziemeļu iela 4, Lidosta "Rīga", Mārupes pagasts, Mārupes novads, LV-1053, Latvia (site of contract wholesale distribution SIA "GP Terminals", number of authorisation Nr.L00112)

Union Format for a Wholesale Distribution Authorisation	L00135
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