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RTF Template


State Agency Of Medicines Of Latvia

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

L00101

2. Name of Authorisation Holder

:

ExpPharmGroup SIA

(ORG-100025005 / LOC-100057887)

3. Address(es) of Site(s)

:

Ziemelu Iela 4, Marupes Novads, 1053, Latvia 




4. Legally registered address of Authorisation Holder

:

Simana Iela 11 K-2 27, Riga, 1005

5. Scope of authorisation (complete for each site under 4)

:

ANNEX 1

6. Legal basis of authorisation

:

Art.40 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

:

2024-05-02

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: ExpPharmGroup SIA

(ORG-100025005 / LOC-100066095)

, Ziemelu Iela 4, Marupes Novads, 1053, Latvia   



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 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  holding of medicinal products in Ziemeļu iela 4, Lidosta "Rīga", Mārupes pagasts, Mārupes novads, LV-1053, Latvia (site of contract wholesale distribution SIA "GP TERMINALS", number of authorisation Nr.L00112).



*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

L00101


Page 1





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