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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	:	567D
2. Name of Authorisation Holder	:	Euro Pharmamed S.R.L. (ORG-100037908 / LOC-100063215)
3. Address(es) of Site(s)	:	Strada Industriala Nr 6, Constanta, 900147, Romania Strada Varlaam Mitropolit 56, Iasi, 700198, 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)	:	Complete address: Şos. Industrială nr.6, lot 1, clădirea C29, spaţiul nr.2, în incinta Logistic Park SA, Mun. Constanţa, Jud. Constanţa, cod poştal 900147 Complete address: Str. Mitropolit Varlaam nr.56, spaţiul 2, Mun. Iaşi, cod poştal 700224

4. Legally registered address of Authorisation Holder	:	Strada Varlaam Mitropolit 56, Iasi, 700198
4.a. Additional details on units inspected of registrant's legal address (optional)	:	Complete address: Str. Mitropolit Varlaam nr. 56, biroul nr.2 şi depozit, Mun. Iaşi, Jud. Iaşi, cod poştal 700224
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	:	2022-10-04
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: Euro Pharmamed S.R.L.

(ORG-100037908 / LOC-100063216)

, Strada Industriala Nr 6, Constanta, 900147, Romania

Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Complete address: Şos. Industrială nr.6, lot 1, clădirea C29, spaţiul nr.2, în incinta Logistic Park SA, Mun. Constanţa, Jud. Constanţa, cod poştal 900147

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

2.2. Holding

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

Any restrictions or clarifying remarks (for all users): In addition, the transportation is performed by A&S Med Warehouse SRL.

Activitatea de transport se efectuează de către beneficiarul de contract A&S Med Warehouse SRL.

Name and address of the site: Euro Pharmamed S.R.L.

(ORG-100037908 / LOC-100063215)

, Strada Varlaam Mitropolit 56, Iasi, 700198, Romania

Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Complete address: Str. Mitropolit Varlaam nr.56, spaţiul 2, Mun. Iaşi, cod poştal 700224

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

2.2. Holding

2.3. Supply

2.4. Export

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

Any restrictions or clarifying remarks (for all users): In addition, the transportation is performed by A&S Med Warehouse SRL according to the concluded transportation services agreement.

Activitatea de transport se efectuează de către beneficiarul de contract A&S Med Warehouse SRL conform contractului de transport încheiat.

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

Union Format for a Wholesale Distribution Authorisation	567D
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