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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-09-07

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	:	801-6/2025-5
2. Name of Authorisation Holder	:	Polymetria distribucija in storitve d.o.o. (ORG-100048047 / LOC-100095834)
3. Address(es) of Site(s)	:	Poslovna Cona A 2, Sencur, 4208, Slovenia

4. Legally registered address of Authorisation Holder	:	Poslovna Cona A 2, Sencur, 4208
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	:	2025-04-28
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: Polymetria distribucija in storitve d.o.o.

(ORG-100048047 / LOC-100095834)

, Poslovna Cona A 2, Sencur, 4208, 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

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): Warehouse at: Marifarm, proizvodnja in storitve d.o.o., Minařikova ulica 8, 2000 Maribor

WDA is valid until 12. 2. 2030.

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

Reason for Withdrawing:

Withdrawn on the proposal of WDA holder.

Union Format for a Wholesale Distribution Authorisation	801-6/2025-5
	Page 1

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