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RTF Template

State Medicines Control Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	0338
2. Name of Authorisation Holder	:	Uždaroji akcinė bendrovė "SIROWA VILNIUS"
3. Address(es) of Site(s)	:	Eišiškių pl. 8A, Vilniaus m. sav., Vilniaus m., LT-02184, Lithuania

4. Legally registered address of Authorisation Holder	:	Eišiškių pl. 8A, Vilniaus m. sav., Vilniaus m.,, LT-02184
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2005-09-13
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: Uždaroji akcinė bendrovė "SIROWA VILNIUS"

, Eišiškių pl. 8A, Vilniaus m. sav., Vilniaus m., LT-02184, Lithuania

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Herbal medicinal products Augaliniai preparatai

Any restrictions or clarifying remarks (for all users): Agreement on warehousing and handling of stores of 1st June 2016 with Oribalt Vilnius, UAB, Maišinės k. 1C, Lentvario sen., Trakų r. sav., Lithuania (Wholesale Distribution Authorisation No. 0102). Wholesale distribution operations performed according to the agreement: reception, verification, holding (warehousing), collection of medicinal products and delivery of medicinal products to consignees, services on handling of stores.

2016-06-01 sandėliavimo ir atsargų tvarkymo sutartis su Oribalt Vilnius, UAB, Maišinės k. 1C, Lentvario sen., Trakų r. sav. (Didmeninio platinimo licencija Nr. 0102). Pagal sutartį vykdomi didmeninio platinimo veiksmai: vaistinių preparatų priėmimas, patikrinimas, laikymas (saugojimas), surinkimas, pristatymas gavėjams ir atsargų tvarkymo paslaugos.

*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	0338
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