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RTF Template

State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	0922
2. Name of Authorisation Holder	:	Rosa LT, UAB
3. Address(es) of Site(s)	:	Kareivių g. 6, Vilniaus m. sav., Vilniaus m, LT-09117, Lithuania

4. Legally registered address of Authorisation Holder	:	Kareivių g. 6, Vilniaus m. sav., Vilniaus m., LT-09117, Lithuania
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2019-08-12
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: Rosa LT, UAB

, Kareivių g. 6, Vilniaus m. sav., Vilniaus m, LT-09117, Lithuania

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

1.3. without a Marketing Authorisation 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

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Agreement on service of 21 June 2019 No. ENT/PAS/2019/06/21 with UAB „ENTAFARMA", Klonėnų vs. 1, Jauniūnų sen., Širvintų r. sav. Lithuania (Wholesale Distribution Authorisation No. 0105). Wholesale distribution operations performed according to the agreement: reception, holding (storage), collection and transportation of medicinal products.

2019-06-21 paslaugos sutartis Nr. ENT/PAS/2019/06/21 su UAB „ENTAFARMA", Klonėnų vs. 1, Jauniūnų sen., Širvintų r. sav. (Didmeninio platinimo licencija Nr. 0105). Pagal sutartį atliekami didmeninio platinimo veiksmai : vaistinių preparatų priėmimas, laikymas (saugojimas), surinkimas ir transportavimas.

Union Format for a Wholesale Distribution Authorisation	0922
	Page 1

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