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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	:	0917
2. Name of Authorisation Holder	:	Uždaroji akcinė bendrovė "Aconitum"
3. Address(es) of Site(s)	:	Inovacijų g. 4, Kauno r. sav., Karmėlavos sen., Biruliškių km., LT-54469, Lithuania

4. Legally registered address of Authorisation Holder	:	Inovacijų g. 4, Kauno r. sav., Karmėlavos sen., Biruliškių k., LT-54469, 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	:	2019-05-03
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 "Aconitum"

, Inovacijų g. 4, Kauno r. sav., Karmėlavos sen., Biruliškių km., LT-54469, Lithuania

1. MEDICINAL PRODUCTS

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

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Agreement No. ACTIO-20180911 on providing services of 5 March 2019 with UAB "Actiofarma", Islandijos pl. 209A, Kauno m., Kauno m. sav. Lithuania (Wholesale Distribution Authorisation No. 0859). Wholesale distribution operations performed according to the agreement: reception of medicinal products, holding (storage), collection and transportation.

2019-03-05 paslaugų teikimo sutartis Nr. ACTIO-20180911 su UAB "Actiofarma", Islandijos pl. 209A, Kauno m., Kauno m. sav. (Didmeninio platinimo licencija Nr. 0859). Pagal sutartį vykdomi didmeninio platinimo veiksmai: vaistinių preparatų priėmimas, laikymas (saugojimas), surinkimas ir transportavimas.

*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	0917
	Page 1

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