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RTF Template

State Institute For Drug Control

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	sukls420271/2025
2. Name of Authorisation Holder	:	Olikla s.r.o. (ORG-100007584 / LOC-100010567)
3. Address(es) of Site(s)	:	Prazska 390, Cerne Budy, 285 06, Czechia K Perovne 945/7, Hostivar, Prague, 102 00, Czechia

4. Legally registered address of Authorisation Holder	:	Namesti Smirickych 42, Kostelec Nad Cernymi Lesy, Stredocesky, 281 63
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	:	2025-11-28
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: Olikla s.r.o.

(ORG-100007584 / LOC-100072629)

, Prazska 390, Cerne Budy, 285 06, 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

Name and address of the site: Olikla s.r.o.

(ORG-100007584 / LOC-100063218)

, K Perovne 945/7, Hostivar, Prague, 102 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

Union Format for a Wholesale Distribution Authorisation	sukls420271/2025
	Page 1

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