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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	:	159D
2. Name of Authorisation Holder	:	B. BRAUN MEDICAL S.R.L.
3. Address(es) of Site(s)	:	Piaţa 1 Mai nr. 4-5, Mun. Cluj Napoca, Jud. Cluj, 400085, Romania Şos. Andronache nr. 203, clădirea C6, Mun. Bucureşti, sectorul 2, cod poştal 022524, Romania Sat Sânandrei, Str. Bernd Braun, nr.1,, Com Sânandrei, Jud. Timiş, Cod postal 307375, Romania

4. Legally registered address of Authorisation Holder	:	Sat Sânandrei, Str. Bernd Braun nr.1, birou 4, et.1, Comuna Sânandrei, jud. Timiş, cod poştal 307375, 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	:	2021-03-19
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: B. BRAUN MEDICAL S.R.L.

, Piaţa 1 Mai nr. 4-5, Mun. Cluj Napoca, Jud. Cluj, 400085, Romania

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

Any restrictions or clarifying remarks (for all users): Transport may be carried out by qualified contract acceptors as well

Activitatea de transport se efectuează şi de către beneficiarii de contracte calificaţi.

Name and address of the site: B. BRAUN MEDICAL S.R.L.

, Şos. Andronache nr. 203, clădirea C6, Mun. Bucureşti, sectorul 2, cod poştal 022524, Romania

1. MEDICINAL PRODUCTS

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

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.4. Other products: medical devices, dietary supplements, cosmetics, biocidal products, dispozitive medicale, suplimente alimentare, cosmetice, produse biocide

Name and address of the site: B. BRAUN MEDICAL SRL

, Sat Sânandrei, Str. Bernd Braun, nr.1,, Com Sânandrei, Jud. Timiş, Cod postal 307375, Romania

1. MEDICINAL PRODUCTS

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

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

Any restrictions or clarifying remarks (for all users): Transport may be carried out by qualified contract acceptors as well

Activitatea de transport se efectuează şi de către beneficiarii de contracte calificaţi.

*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	159D
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