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RTF Template

National Authority Of Medicines And Medical Devices

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	565D
2. Name of Authorisation Holder	:	S.C. FARMIMPLANT S.R.L.
3. Address(es) of Site(s)	:	Str. Burniţei nr. 8-16, zona B, parter plus pod amenajat, Mun. Bucureşti, sectorul 3, cod poştal 032342, Romania

4. Legally registered address of Authorisation Holder	:	Str. Burniţei nr. 8-16, camera 3, Mun. Bucureşti, sectorul 3, cod poştal 032342
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	:	2022-10-19
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: FARMIMPLANT S.R.L.

, Str. Burniţei nr. 8-16, zona B, parter plus pod amenajat, Mun. Bucureşti, sectorul 3, cod poştal 032342, Romania

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

2.3. 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)

Any restrictions or clarifying remarks (for all users): The current WDA is valid only if the terms of the transportation services agreement signed with SC MSL Logistic Services Distribution SRL, are complied with.

Prezenta Autorizaţie de distribuţie angro este validă numai respectându-se prevederile contractului de prestări servicii transport încheiat cu SC MSL Logistic Services Distribution 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	565D
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