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RTF Template

National Agency for Medicines and Medical Devices

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	536D
2. Name of Authorisation Holder	:	S.C. ALLERGAN S.R.L.
3. Address(es) of Site(s)	:	Str. Horia, Cloşca şi Crişan nr. 7, camera C2 B3 şi camera C2 B13, depozit C2, Oraş Otopeni, Jud. Ilfov, cod postal 075100, Romania

4. Legally registered address of Authorisation Holder	:	Splaiul Unirii nr. 165, Clădirea de birouri TN Offices 1, et. 9, Mun. Bucureşti, Sectorul 3, Cod poştal 030133, 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	:	2018-03-22
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: ALLERGAN S.R.L.

, Str. Horia, Cloşca şi Crişan nr. 7, camera C2 B3 şi camera C2 B13, depozit C2, Oraş Otopeni, Jud. Ilfov, cod postal 075100, 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: medical devices, dispozitive medicale

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 Nucleos Logistics S.R.L. are complied with.

Prezenta Autorizaţie de distribuţie angro este validă numai respectându-se prevederile contractului de custodie şi prestări servicii logistice încheiat cu SC Nucleos Logistics S.R.L.

*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	536D
	Page 1

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