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RTF Template


State Agency Of Medicines

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

L00016

2. Name of Authorisation Holder

:

Unifarma SIA

(ORG-100003700 / LOC-100000988)

3. Address(es) of Site(s)

:

Vangazu Iela 23, Riga, 1024, Latvia 

Noliktava Makonisi Bauskas Novads, Iecava, 3913, Latvia 




4. Legally registered address of Authorisation Holder

:

Vangazu Iela 23, Riga, 1024

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

:

2026-07-15

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: Unifarma SIA

(ORG-100003700 / LOC-100000988)

, Vangazu Iela 23, Riga, 1024, Latvia   



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) distribution of medicinal products of contract wholesalers


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.1. Narcotic or psychotropic products** 

   3.2. Products requiring low temperature handling 

     3.2.1. Temperatures between 2 to 8 °C 

     3.2.2. Other temperatures: (please specify) between 8°C and 15°C




Any restrictions or clarifying remarks (for all users):  3.1.1. psychotropic medicinal products, 3.1.3. narcotic and equivalent thereto psychotropic medicinal products


Name and address of the site: Unifarma SIA

(ORG-100003700 / LOC-100066187)

, Noliktava Makonisi Bauskas Novads, Iecava, 3913, Latvia   



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

   2.2. Holding 

   2.5. Other activities(s): (please specify) distribution of medicinal products of contract wholesalers


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.1. Narcotic or psychotropic products** 




Any restrictions or clarifying remarks (for all users):  3.1.1. psychotropic medicinal products
Authorized activities do not include storage and distribution of cold chain and narcotic medicinal products. Storing of psychotropic medicinal products is allowed only in quarantine status.



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

**Without prejudice to further authorisations as may be required according to national legislation.













Union Format for a Wholesale Distribution Authorisation

L00016


Page 1





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