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RTF Template


Agency For Medicinal Products And Medical Devices Of Croatia

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

UP/I-530-03/23-06/13; 381-13-08/353-24-08

2. Name of Authorisation Holder

:

Salvus d.o.o.

(ORG-100005199 / LOC-100033012)

3. Address(es) of Site(s)

:

Toplicka Cesta 100, Donja Stubica, 49240, Croatia 

Toplicka Cesta 100/1, Donja Stubica, 49240, Croatia 




4. Legally registered address of Authorisation Holder

:

Toplicka Cesta 100, Donja Stubica, 49240, Croatia

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

:

2024-10-31

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: Salvus d.o.o.

(ORG-100005199 / LOC-100033012)

, Toplicka Cesta 100, Donja Stubica, 49240, Croatia   



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 

   3.4. Other products: See Any restrictions or clarifying remarks (for all users)




Any restrictions or clarifying remarks (for all users):  Medicinal products from section 3.4 are Parallel wholesale distribution, Parallel imported medicinal products and Traditional herbal medicinal products.


Name and address of the site: Salvus d.o.o.

(ORG-100005199 / LOC-100093678)

, Toplicka Cesta 100/1, Donja Stubica, 49240, Croatia   



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 

   3.4. Other products: See Any restrictions or clarifying remarks (for all users)




Any restrictions or clarifying remarks (for all users):  Medicinal products from section 3.4 are Parallel wholesale distribution, Parallel imported medicinal products and Traditional herbal medicinal products.



*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

UP/I-530-03/23-06/13; 381-13-08/353-24-08


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