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RTF Template


National Authority Of Medicines And Medical Devices Of Romania

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

578D

2. Name of Authorisation Holder

:

BGP PRODUCTS S.R.L.

(ORG-100034224 / LOC-100054149)

3. Address(es) of Site(s)

:

Str Gara Herastrau Nr 2 Equilibrium Cladirea 1 Etaj 3 Sectorul 2, Bucharest, 020334, Romania 

3.a. Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations)

:

Completed address: Str. Gara Herăstrău nr.2, Equilibrium, Clădirea 1, et.3, camera E04.26 Mylan, Mun. Bucureşti, sectorul 2, cod poştal 020334 




4. Legally registered address of Authorisation Holder

:

Str Gara Herastrau Nr 2 Equilibrium Cladirea 1 Etaj 3 Sectorul 2, Bucharest, 020334, Romania

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

:

2024-12-05

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: BGP PRODUCTS S.R.L.

(ORG-100034224 / LOC-100054149)

, Str Gara Herastrau Nr 2 Equilibrium Cladirea 1 Etaj 3 Sectorul 2, Bucharest, 020334, Romania   


Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Completed address: Str. Gara Herăstrău nr.2, Equilibrium, Clădirea 1, et.3, camera E04.26 Mylan, Mun. Bucureşti, sectorul 2, cod poştal 020334


Human medicinal products


1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.3. Supply 


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 

   3.3. Other products: (please specify here or make a reference to Annex 5) medicines for special needs medicamente pentru nevoi speciale



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 MSL LOGISTIC SERVICES DISTRIBUTION SRL are complied with.

Prezenta Autorizaţie de distribuţie angro este validă numai respectându-se prevederile contractului de custodie şi prestări servicii logistice încheiat cu MSL LOGISTIC SERVICES DISTRIBUTION SRL.



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













Union Format for a Wholesale Distribution Authorisation

578D


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