Bulgarian Drug Agency
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
BG/WDA/MP-0594
2. Name of Authorisation Holder
Bulmar Ml OOD
(ORG-100021967 / LOC-100032400)
3. Address(es) of Site(s)
кв. Манастирски ливади, ул. Пирин № 32/, 32 Pirin Str., "Manastirski livadi" district, гр. София/ Sofia, 1618, Bulgaria
2E Akad. Ivan Geshov Blvd., Busin. Center Serdica,build.6, kota 0,st.3, Sofia, region Vazrajdane, 1330, Bulgaria
4. Legally registered address of Authorisation Holder
Kv Manastirski Livadi, Ulitsa Pirin 32, Sofia, 1618
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
2025-09-24
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
SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION
Name and address of the site: „БУЛМАР МЛ" ООД/ BULMAR ML OOD
, кв. Манастирски ливади, ул. Пирин № 32/, 32 Pirin Str., "Manastirski livadi" district, гр. София/ Sofia, 1618, Bulgaria
Human 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
2.1. Procurement
2.2. Holding
2.3. Supply
2.4. Export
3.1. Narcotic or psychotropic products**
3.2. Products requiring low temperature handling
3.2.1. Temperatures between 2 to 8 °C
3.2.2. Other temperatures: (please specify) 15°C - 25°C 15°C - 25°C
3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal products derived from blood and immunological medicinal products лекарствени продукти получени от кръв и имунологични лекарствени продукти
Name and address of the site: BULMAR ML OOD
, 2E Akad. Ivan Geshov Blvd., Busin. Center Serdica,build.6, kota 0,st.3, Sofia, region Vazrajdane, 1330, Bulgaria
3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal products derived from blood and immunological medicinal products лекарствени продукти получени от кръв и имунологични лекарстени продукти
*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
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