Thu 22 Oct 2026 11:39:49 BST
Search Company
*

Active Substance
New Active Substance
Search Site
--
*

Create Site
--
*
*
*
*
*
*
Update Site
Current data stored in EudraGMDP databaseCurrent data stored in OMS
--
Characters remaining:4000/4000
New Active Substance Importation
Active Substance*
Active Substance (English):
Active Substance (NL):
NCA Reference Key:
3rd Country Manufacturer
3rd Country ManufacturerOMS Location IdentifierOMS Organisation IdentifierLegal AddressNCA Reference KeyConfidentialEditDelete
No records found.
3rd Country Distributor
3rd Country DistributorOMS Location IdentifierOMS Organisation IdentifierLegal AddressNCA Reference KeyConfidentialEditDelete
No records found.
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

:

801-44/2024-13

2. Name of Authorisation Holder

:

FARMAKEM proizvodnja posrednistvo trgovina najemi svetovanje in storitve d.o.o.

(ORG-100035442 / LOC-100056172)

3. Address(es) of Site(s)

:

Bohova 73, Hoce, 2311, Slovenia 

Litostrojska Cesta 46 A, Ljubljana, 1000, Slovenia 




4. Legally registered address of Authorisation Holder

:

Bohova 73, Hoce, 2311, Slovenia

5. Scope of authorisation

:

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 wholesale distribution authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2025-02-24

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: FARMAKEM proizvodnja posrednistvo trgovina najemi svetovanje in storitve d.o.o.

(ORG-100035442 / LOC-100056172)

, Bohova 73, Hoce, 2311, Slovenia   



Human medicinal products


1. MEDICINAL PRODUCTS

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

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

   1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

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** 




Name and address of the site: SALUS Veletrgovina druzba za promet s farmacevtskimi medicinskimi in drugimi proizvodi d.o.o.

(ORG-100017689 / LOC-100026447)

, Litostrojska Cesta 46 A, Ljubljana, 1000, Slovenia   



Human medicinal products


1. MEDICINAL PRODUCTS

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

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

   1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

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** 

     3.2.1. Temperatures between 2 to 8 °C 





*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

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













Union Format for a Wholesale Distribution Authorisation

801-44/2024-13


Page 1





Loading, please wait