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RTF Template

Bulgarian Drug Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	BG/WDA/MP-0023
2. Name of Authorisation Holder	:	„ФАРМИМПОРТ" АД / „PHARMIMPORT" AD
3. Address(es) of Site(s)	:	ул. „ Фредерик Жолио Кюри" № 20, ет. 12 /20 Fr. Joliot Curie Str.fl. 12, гр. София /Sofia, район Изгрев/Izgrev district, 1113, Bulgaria

4. Legally registered address of Authorisation Holder	:	ул. „ Фредерик Жолио Кюри" № 20, ет. 12 /20 Frеderic Joliot-Curie Str., fl. 12, гр. София /Sofia, район Изгрев/Izgrev district, 1113, Bulgaria
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	:	2018-04-12
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: „ФАРМИМПОРТ" АД / „PHARMIMPORT" AD

, ул. „ Фредерик Жолио Кюри" № 20, ет. 12 /20 Fr. Joliot Curie Str.fl. 12, гр. София /Sofia, район Изгрев/Izgrev district, 1113, Bulgaria

1. MEDICINAL PRODUCTS

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

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

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.2. Medicinal gases

3.3. Cold chain products(requiring low temperature handling)

*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	BG/WDA/MP-0023
	Page 1

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