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RTF Template

State Institute For Drug Control

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	sukls303008/2025
2. Name of Authorisation Holder	:	Avenier a.s. (ORG-100013643 / LOC-100022756)
3. Address(es) of Site(s)	:	Holicka 49a/1173, Hodolany, 779 00, Czechia U Hrubku 1569, Nova Ves, 709 00, Czechia Edvarda Benese 530/21, Doudlevce, Plzen, 301 00, Czechia Zdebradska 72, Jazlovice, Ricany, 251 01, Czechia Zatecka 1488, Most, 434 01, Czechia Svetlogorska 2765, Tabor, 390 05, Czechia Steblova 105, Steblova, 533 45, Czechia Riegrova 4337/10, Jablonec Nad Nisou, 466 01, Czechia Modricka 979/75, Moravany, 664 48, Czechia

4. Legally registered address of Authorisation Holder	:	Bidlaky 837/20, Styrice, Brno, 639 00
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	:	2025-08-08
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: Avenier a.s.

(ORG-100013643 / LOC-100062978)

, Holicka 49a/1173, Hodolany, 779 00, Czechia

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) between -60 to -90 °C, between -15 to -25 °C

Name and address of the site: Avenier a.s.

(ORG-100013643 / LOC-100077911)

, U Hrubku 1569, Nova Ves, 709 00, Czechia

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) between -60 to -90 °C, between -15 to -25 °C

Name and address of the site: Avenier a.s.

(ORG-100013643 / LOC-100022268)

, Edvarda Benese 530/21, Doudlevce, Plzen, 301 00, Czechia

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) between -60 to -90 °C, between -15 to -25 °C

Name and address of the site: Avenier a.s.

(ORG-100013643 / LOC-100019168)

, Zdebradska 72, Jazlovice, Ricany, 251 01, Czechia

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) between -60 to -90 °C, between -15 to -25 °C

Name and address of the site: Avenier a.s.

(ORG-100013643 / LOC-100092385)

, Zatecka 1488, Most, 434 01, Czechia

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) between -60 to -90 °C, between -15 to -25 °C

Name and address of the site: Avenier a.s.

(ORG-100013643 / LOC-100067965)

, Svetlogorska 2765, Tabor, 390 05, Czechia

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) between -60 to -90 °C, between -15 to -25 °C

Name and address of the site: Avenier a.s.

(ORG-100013643 / LOC-100068822)

, Steblova 105, Steblova, 533 45, Czechia

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) between -60 to -90 °C, between -15 to -25 °C

Name and address of the site: Avenier a.s.

(ORG-100013643 / LOC-100068665)

, Riegrova 4337/10, Jablonec Nad Nisou, 466 01, Czechia

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) between -60 to -90 °C, between -15 to -25 °C

Name and address of the site: Avenier a.s.

(ORG-100013643 / LOC-100082147)

, Modricka 979/75, Moravany, 664 48, Czechia

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) between -60 to -90 °C, between -15 to -25 °C

Union Format for a Wholesale Distribution Authorisation	sukls303008/2025
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