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RTF Template

Latvian State Agency of Medicines

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	L00083
2. Name of Authorisation Holder	:	Sabiedrība ar ierobežotu atbildību "INSBERGS"
3. Address(es) of Site(s)	:	Dzirciema iela 5A, Rīga, LV-1083, Latvia

4. Legally registered address of Authorisation Holder	:	Dzirciema iela 5A, Rīga, LV-1083, Latvia
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-01-14
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: SIA "INSBERGS" zāļu lieltirgotava "Dzirciema aptiekas noliktava"

, Dzirciema iela 5A, Rīga, LV-1083, Latvia

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Annex 1 Paragraph 3.3. - it is permitted to distribute only medicines requiring cold temperature storage (from 2°C to 8°C)

*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	L00083
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