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RTF Template

National Authority Of Medicines And Medical Devices

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	657D
2. Name of Authorisation Holder	:	Pharaon Healthcare Caucasus Central Asia S.R.L. (ORG-100041411 / LOC-100068166)
3. Address(es) of Site(s)	:	Strada Biharia 67-77 Building C Room 29 Ground Floor Sector 1, Bucharest, 013981, Romania

4. Legally registered address of Authorisation Holder	:	Strada Biharia 67-77 Building D Floor 2 Sector 1, Bucharest, 013981, Romania
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-09-30
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: Pharaon Healthcare Caucasus Central Asia S.R.L.

(ORG-100041411 / LOC-100089971)

, Strada Biharia 67-77 Building C Room 29 Ground Floor Sector 1, Bucharest, 013981, Romania

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

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) medicines authorized in the EU that are not intended for the RO market medicamente care au autorizaţie de punere pe piaţă eliberată de autorităţile competente ale unui st

Any restrictions or clarifying remarks (for all users): The current WDA is valid only if the terms of the storage and logistical services agreement (storage, handling, transport) signed with Romastru Trading SRL are complied with.In addition, the transportation is performed by EKOL INTERNATIONAL LOGISTICS SRL.

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

Union Format for a Wholesale Distribution Authorisation	657D
	Page 1

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