State Institute For Drug Control
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
sukls119402/2026
2. Name of Authorisation Holder
FL Service s.r.o.
(ORG-100018515 / LOC-100036490)
3. Address(es) of Site(s)
Logisticka 100, Pavlov, Stredocesky, 273 51, Czechia
4. Legally registered address of Authorisation Holder
Na Porici 1047/26, Nove Mesto, Prague 1, Prague, 110 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
2026-04-01
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
SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION
Name and address of the site: FL Service s.r.o.
(ORG-100018515 / LOC-100080268)
, Logisticka 100, Pavlov, Stredocesky, 273 51, Czechia
Human 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*
2.1. Procurement
2.2. Holding
2.3. Supply
2.4. Export
3.2. Products requiring low temperature handling
3.2.1. Temperatures between 2 to 8 °C
3.2.2. Other temperatures: (please specify) 8 to 15 °C
*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.
Union Format for a Wholesale Distribution Authorisation
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Sat 24 Oct 2026 15:40:10 BST
