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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

Human medicinal products

1. Authorisation Number	:	0893
2. Name of Authorisation Holder	:	Jorinis UAB (ORG-100019856 / LOC-100075287)
3. Address(es) of Site(s)	:	Islandijos Pl 217-14, Kauno M Sav, Kovno, 49165, Lithuania

4. Legally registered address of Authorisation Holder	:	Viesios G. 13b, Kauno M. Sav., Kovno, 44105
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	:	2018-05-30
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: Jorinis UAB

(ORG-100019856 / LOC-100064733)

, Islandijos Pl 217-14, Kauno M Sav, Kovno, 49165, Lithuania

Human medicinal products

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

3.1.2. 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 storage of goods in customs warehouse No. ENT-MS/2016-08-25 of 25 August 2016 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 (warehousing), gathering, collection and transportation of medicinal products from the third countries.
Agreemnt on service No. ENT/PAS/2021/01/20 of 20 January 2021 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 (warehousing), gathering, collection and transportation of narcotic and psychotropic medicinal products.

2016-08-25 Prekių saugojimo muitinės sandėlyje sutartis Nr. ENT-MS/2016-08-25 su UAB "ENTAFARMA", Klonėnų vs. 1, Jauniūnų sen., Širvintų r. sav., (Didmeninio platinimo licencija Nr. 0105). Pagal sutartį vykdomi didmeninio platinimo veiksmai: vaistinių preparatų iš trečiųjų šalių priėmimas, saugojimas (laikymas), surinkimas, komplektavimas ir transportavimas.
2021-01-20 paslaugos sutartis Nr. ENT/PAS/2021/01/20 su UAB "ENTAFARMA", Klonėnų vs. 1, Jauniūnų sen., Širvintų r. sav., (Didmeninio platinimo licencija Nr. 0105). Pagal sutartį vykdomi didmeninio platinimo veiksmai: narkotinių ir psichotropinių vaistinių preparatų priėmimas, saugojimas (laikymas), surinkimas, komplektavimas 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	0893
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