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RTF Template

National Agency for Medicines and Medical Devices

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	385D
2. Name of Authorisation Holder	:	S.C. DEPOTHEKE DEPOZITUL FARMACIILOR INDEPENDENTE S.R.L.
3. Address(es) of Site(s)	:	Str. Laboratorului nr.15B, locaţia depozitul nr.12 din C4, Mun. Ploieşti, Jud. Prahova, cod poştal 100070, Romania

4. Legally registered address of Authorisation Holder	:	Str. Laboratorului nr.15B, locaţia depozitul nr.12 din C4, Mun. Ploieşti, Jud. Prahova, cod poştal 100070, Romania
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2018-10-09
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: DEPOTHEKE DEPOZITUL FARMACIILOR INDEPENDENTE S.R.L.

, Str. Laboratorului nr.15B, locaţia depozitul nr.12 din C4, Mun. Ploieşti, Jud. Prahova, cod poştal 100070, 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

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Union Format for a Wholesale Distribution Authorisation	385D
	Page 1

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