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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	:	63D
2. Name of Authorisation Holder	:	PRISUM INTERNATIONAL TRADING CO S.R.L.
3. Address(es) of Site(s)	:	Str. Ion Minulescu nr. 60, Unitatea 2, et. 1, Spaţiul A-1-1, Mun. Bucureşti, Sectorul 3, Cod poştal 031216, Romania

4. Legally registered address of Authorisation Holder	:	Calea Plevnei nr. 146, Mun. Bucureşti, Sectorul 6, Cod poştal 060014, 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	:	2019-12-19
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: PRISUM INTERNATIONAL TRADING CO S.R.L.

, Str. Ion Minulescu nr. 60, Unitatea 2, et. 1, Spaţiul A-1-1, Mun. Bucureşti, Sectorul 3, Cod poştal 031216, Romania

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

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): Transport may be carried out by qualified contract acceptor as well

Activitatea de transport se efectuează şi de către beneficiarul de contract calificat.

*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	63D
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