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RTF Template


Finnish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

FIMEA/2022/000880

2. Name of Authorisation Holder

:

Verman Ab Oy

(ORG-100002945 / LOC-100071303)

3. Address(es) of Site(s)

:

Ayritie 8 C, Vantaa, 01510, Finland 




4. Legally registered address of Authorisation Holder

:

Pl 164, Vantaa, 01511

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

:

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 wholesaling authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2022-07-01

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: Verman Ab Oy

(ORG-100002945 / LOC-100071304)

, Ayritie 8 C, Vantaa, 01510, Finland   



Human medicinal products


1. MEDICINAL PRODUCTS

   1.1. with a Marketing Authorisation in EEA country(s)


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.4. Export 

   2.5. Other activities(s): Export to other EEA countries and distribution of medicinal product samples


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.4. Other products: Medicinal product samples




Any restrictions or clarifying remarks (for all users):  2.2. Holding and 2.4. Export outside EEA is limited to medicinal products that are not used in human or animals.



*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

FIMEA/2022/000880


Page 1





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