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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	:	0886
2. Name of Authorisation Holder	:	UAB Santonika
3. Address(es) of Site(s)	:	Veiverių g.134B, Kauno m. sav,, Kauno m., LT-46353, Lithuania

4. Legally registered address of Authorisation Holder	:	Veiverių g.134B, Kauno m., sav., Kauno m., LT-46353, Lithuania
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	:	2015-10-15
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: UAB Santonika

, Veiverių g.134B, Kauno m. sav,, Kauno m., LT-46353, 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

2.2. Holding

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)

Any restrictions or clarifying remarks (for all users): Agreement on service for storage of goods in customs warehouse Nr. ENT-MS/20180419 / SAN-2018-047 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: holding (storage) of medicinal products imported from the third countries.

2018-04-19 prekių saugojimo muitinės sandėlyje sutartis Nr. ENT-MS/20180419 / SAN-2018-047 su UAB „ENTAFARMA", Klonėnų vs. 1, Jauniūnų sen., Širvintų r. sav. (Didmeninio platinimo licencija Nr. 0105). Pagal sutartį atliekami didmeninio platinimo veiksmai : vaistinių preparatų importuojamų iš trečiųjų šalių laikymas (saugojimas).

*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	0886
	Page 1

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