Sun 25 Oct 2026 01:52:03 BST

Search Company

OMS Organisation Identifier:

OMS Location Identifier:

NCA Reference Key:

Address:

Country:

Active Substance

New Active Substance

Search Site

Create Site

Update Site

Current data stored in EudraGMDP database

Current data stored in OMS

DUNS Number:

NCA Reference Key:

Site Name:

OMS Organisation Identifier:

OMS Location Identifier:

Address Line 1:

Address Line 2:

Address Line 3:

Address Line 4:

City:

County:

Postcode:

Country:

Additional Details on Units Inspected

Site under Compliance Management:

Compliance Management comments:

Characters remaining:4000/4000

Overwrite with current OMS data.:

New Active Substance Importation

Active Substance*

Active Substance (English):
Active Substance (NL):
NCA Reference Key:

3rd Country Manufacturer

3rd Country Manufacturer	OMS Location Identifier	OMS Organisation Identifier	Legal Address	NCA Reference Key	Confidential	Edit	Delete
No records found.

3rd Country Distributor

3rd Country Distributor	OMS Location Identifier	OMS Organisation Identifier	Legal Address	NCA Reference Key	Confidential	Edit	Delete
No records found.

RTF Template

National Agency for Medicines and Medical Devices

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	76D
2. Name of Authorisation Holder	:	S.C. ROCHE ROMÂNIA S.R.L.
3. Address(es) of Site(s)	:	P-ţa Presei Libere nr. 3-5, Clădirea City Gate, Turnul de Sud, etajele 4 A, 5 şi 6, Mun. Bucureşti, sector 1, 013702, Romania

4. Legally registered address of Authorisation Holder	:	P-ţa Presei Libere nr. 3-5, Clădirea City Gate, Turnul de Sud, etajele 4 A, 5 şi 6, Mun. Bucureşti, sector 1, 013702, 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	:	2017-02-27
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: ROCHE ROMÂNIA S.R.L.

, P-ţa Presei Libere nr. 3-5, Clădirea City Gate, Turnul de Sud, etajele 4 A, 5 şi 6, Mun. Bucureşti, sector 1, 013702, Romania

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: other biological medicines, alte medicamente biologice

Any restrictions or clarifying remarks (for all users): The current WDA is valid only if the terms of the storage and logistical services agreement signed with SC H. ESSERS LOGISTICS S.R.L, in addition to the terms of the transportation services agreement signed with SC MSL Logistic Services Distribution SRL and SC Romastru Trading SRL are complied with.

Prezenta Autorizaţie de distribuţie angro este validă numai respectându-se prevederile contractului de custodie şi prestări servicii logistice depozitare şi manipulare încheiat cu SC H. ESSERS LOGISTICS S.R.L., precum şi a contractelor de prestări servicii transport încheiate cu SC MSL Logistic Services Distribution SRL şi SC Romastru Trading 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	76D
	Page 1

Loading, please wait