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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

:

L00144

2. Name of Authorisation Holder

:

JAS Worldwide Latvia SIA

(ORG-100049396 / LOC-100084083)

3. Address(es) of Site(s)

:

Marupes Pag., Ziemelu Iela 12, Riga, 1005, Latvia 




4. Legally registered address of Authorisation Holder

:

Marupes Pag., Ziemelu Iela 12, 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

:

2023-12-01

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


ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION



Name and address of the site: JAS Worldwide Latvia SIA

(ORG-100049396 / LOC-100084083)

, Marupes Pag., Ziemelu Iela 12, Riga, 1005, 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 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 

   2.5. Other activities(s): provision of customs warehousing services


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.2. Medicinal products derived from blood 

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  3.1. medicinal products according to Art. 83 of 2001/83/EC
Annex 1 Paragraph 3.3. – in the customs warehouse, it is allowed to store: immunological preparations, drugs obtained from human blood and plasma, cold chain products, ensuring storage conditions at room temperature from +15 °C to +25 °C and in a cold place from +2 °C to +8 °C



*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

L00144


Page 1





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