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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	:	560D
2. Name of Authorisation Holder	:	Genco Pharmaceuticals S.R.L. (ORG-100035257 / LOC-100101121)
3. Address(es) of Site(s)	:	211 Bis Industriilor Street Hall 3, Chiajna, Ilfov, 077040, 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)	:	Complet address: Str. Industriilor 211 BIS, Hala 3, sat Chiajna, com. Chiajna, jud. Ilfov, cod poștal 077040

4. Legally registered address of Authorisation Holder	:	Strada Moinesti 63a Block B3 Floor 11 Duplex Apartment 1105, Bucharest, 061232
4.a. Additional details on units inspected of registrant's legal address (optional)	:	Complete address: Str. Moinești nr.63A, Bl.B3, Etaj11, Duplex ap.1105, Mun. Bucureşti, sectorul 6, cod poştal 061236
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	:	2025-11-18
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: Genco Pharmaceuticals S.R.L.

(ORG-100035257 / LOC-100098256)

, 211 Bis Industriilor Street Hall 3, Chiajna, Ilfov, 077040, Romania

Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Complet address: Str. Industriilor 211 BIS, Hala 3, sat Chiajna, com. Chiajna, jud. Ilfov, cod poștal 077040

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

3.3. Other products: (please specify here or make a reference to Annex 5) parallel import medicines medicamente de import paralel

Any restrictions or clarifying remarks (for all users): The transport is carried out based on logistical services agreement signed with Frigospeed Eurotop SRL and Ahead Translog Solutions SRL which uses transport hub in the following counties: IF, BH, BZ, CJ, CT, DJ, HR, HD, NT, MM.

Transportul se efectuează în baza contractului de prestări servicii transport de către Frigospeed Eurotop SRL și Ahead Translog Solutions SRL care utilizează noduri de transport în jud. IF, BH, BZ, CJ, CT, DJ, HR, HD, NT, MM.

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

Union Format for a Wholesale Distribution Authorisation	560D
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