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RTF Template


State Agency Of Medicines

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

543

2. Name of Authorisation Holder

:

Terviseamet

3. Address(es) of Site(s)

:

Paldiski Mnt 81, Tallinn, 10617, Estonia 




4. Legally registered address of Authorisation Holder

:

Paldiski mnt 81, Haabersti linnaosa, Tallinn, Harju maakond, 10614

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

:

2023-05-18

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: Terviseamet

(ORG-100006963 / LOC-100014318)

, Paldiski Mnt 81, Tallinn, 10617, Estonia   



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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.3. Supply 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 

     3.1.3. Immunological medicinal products 

   3.2. Medicinal gases 

   3.3. Cold chain products(requiring low temperature handling) 

















Union Format for a Wholesale Distribution Authorisation

543


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