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RTF Template

Pharmaceutical Services Ministry Of Health

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	070
2. Name of Authorisation Holder	:	M.A. Pharmaceuticals Trading Limited (ORG-100025014 / LOC-100055568)
3. Address(es) of Site(s)	:	Markou Botsari 3, Limassol, 3040, Cyprus

4. Legally registered address of Authorisation Holder	:	P. O. Box 50222, Limassol, 3602, Cyprus
5. Scope of authorisation	:	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 wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2010-07-22
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: M.A. Pharmaceuticals Trading Limited

(ORG-100025014 / LOC-100046132)

, Markou Botsari 3, Limassol, 3040, Cyprus

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) Immunological medicinal products and Cytotoxic products

Any restrictions or clarifying remarks (for all users): Immunological medicinal products are received, stored and distributed only by Marathon Distributors Ltd.

Cold chain products are stored only at Marathon Distributors Ltd, Blue Pharmacies Public Ltd, MEFAL LTD and KEDIFAP LTD.

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

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

Union Format for a Wholesale Distribution Authorisation	070
	Page 1

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