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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	:	311D
2. Name of Authorisation Holder	:	S.C. PHARM AHEAD S.R.L.
3. Address(es) of Site(s)	:	Str. Prelungirea Gării Căţelu nr.12, parter şi etajul 1, Sat Căldăraru, Com. Cernica, 077037, Romania Str. Lombului nr.FN, parter 593mp şi demisol 333mp, Mun. Cluj Napoca, Jud. Cluj, cod poştal 400227, Romania

4. Legally registered address of Authorisation Holder	:	Str. Energiei nr.14, Lotul nr.2, Camera 1, Mun. Bucureşti, sector 2, 024066, 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	:	2021-03-22
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: PHARM AHEAD S.R.L.

, Str. Prelungirea Gării Căţelu nr.12, parter şi etajul 1, Sat Căldăraru, Com. Cernica, 077037, 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

3.1.1. 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): In addition, the transportation is performed by Ahead Translog Solution SRL which are using an transportation hub in Buzău, Ialomiţa şi Neamţ.counties, according to the concluded transportation services agreement.

Activitatea de transport se efectuează şi de către beneficiarul de contract calificat Ahead Translog Solutions SRL, care utilizează noduri de transport în judeţele: Buzău, Ialomiţa şi Neamţ.

Name and address of the site: PHARM AHEAD S.R.L.

, Str. Lombului nr.FN, parter 593mp şi demisol 333mp, Mun. Cluj Napoca, Jud. Cluj, cod poştal 400227, 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

3.1.1. 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): In addition, the transportation is performed by Ahead Translog Solution SRL which are using an transportation hub in Maramureș, Hunedoara și Dolj.county, according to the concluded transportation services agreement.

Activitatea de transport se efectuează şi de către beneficiarul de contract calificat Ahead Translog Solutions SRL, care utilizează noduri de transport în judeţele: Maramureș, Hunedoara și Dolj.

*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	311D
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