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RTF Template


National Agency for Medicines and Medical Devices of Romania

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

205D

2. Name of Authorisation Holder

:

PHARMNET PLUS S.R.L.

3. Address(es) of Site(s)

:

Strada Rudeni, nr.93, Clădirea CHIT1 A+B1a, Etaj 1, localitatea Chitila, Oraș Chitila, Judeţ Ilfov, cod poștal 077045, Romania 




4. Legally registered address of Authorisation Holder

:

B-dul Dimitrie Pompei, nr.10A, Modulele 1 și 4, clădirea C1, biroul nr. 07, et. 2, Mun. Bucureşti, Sectorul 2, Cod poştal 020337, Romania

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

:

ANNEX 1

6. Legal basis of authorisation

:


7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2021-12-06

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: PHARMNET PLUS SRL

, Strada Rudeni, nr.93, Clădirea CHIT1 A+B1a, Etaj 1, localitatea Chitila, Oraș Chitila, Judeţ Ilfov, cod poștal 077045, Romania   




1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 

     3.1.2. Medicinal products derived from blood 

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 

   3.4. Other products: medicines for special needs, medicines distributed by parallel export, medicines imported in parall medicamente pentru nevoi speciale, medicamente distribuite prin export paralel, medicamente de impo




Any restrictions or clarifying remarks (for all users):  The current WDA is valid only if the terms of the storage and logistical services agreement signed with Europharm Holding SA. are complied with and contracts of transport services concluded with Terra Auto Service SRL, Europharm Holding SA and Drugs4All SRL.

Prezenta Autorizaţie de distribuţie angro este validă numai respectându-se prevederile  contractului de custodie şi prestări servicii logistice încheiat cu Europharm Holding SA şi a contractelor de prestări servicii transport încheiate cu: Terra Auto Service SRL, Europharm Holding SA și Drugs4All SRL.



*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

205D


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