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RTF Template


Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

801-51/2024-10

2. Name of Authorisation Holder

:

ALTAMEDICS d.o.o. druzba za trzenje in registracije s podrocja farmacevtske dejavnosti

(ORG-100005253 / LOC-100054985)

3. Address(es) of Site(s)

:

Ameriska Ulica 2, Ljubljana, 1000, Slovenia 




4. Legally registered address of Authorisation Holder

:

Ameriska Ulica 2, Ljubljana, 1000, Slovenia

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

:

2025-01-17

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: ALTAMEDICS d.o.o. druzba za trzenje in registracije s podrocja farmacevtske dejavnosti

(ORG-100005253 / LOC-100054985)

, Ameriska Ulica 2, Ljubljana, 1000, Slovenia   



Human medicinal products


1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 

   2.5. Other activities(s): (please specify) Entry of medicinal products from EU to RS; Outwards of medicinal products from RS to EU


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.1. Narcotic or psychotropic products** 

   3.2. Products requiring low temperature handling 

     3.2.1. Temperatures between 2 to 8 °C 

   3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal products derived from blood, Immunological medicinal products




Any restrictions or clarifying remarks (for all users):  Warehouse at Salus, Veletrgovina, d.o.o., Litostrojska cesta 46 A, 1000 Ljubljana
Contract for warehouse premises between ALTAMEDICS d.o.o., družba za trženje in registracije s področja farmacevtske dejavnosti and Salus, Veletrgovina, d.o.o., Litostrojska cesta 46 A, 1000 Ljubljana for indefinite duration



**Without prejudice to further authorisations as may be required according to national legislation.













Union Format for a Wholesale Distribution Authorisation

801-51/2024-10


Page 1





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