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RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	OGYÉI/60893-3/2018
2. Name of Authorisation Holder	:	BHV PHARMA Korlátolt Felelősségű Társaság
3. Address(es) of Site(s)	:	Raktár utca 2. Székesfehérvár belterület, hrsz. 8199 „A" épület, 1. kapu; 1. ajtó, 3. és 4. raktár ajtók, Székesfehérvár, 8000, Hungary

4. Legally registered address of Authorisation Holder	:	Raktár utca 2., Székesfehérvár, 8000, Hungary
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	:	2018-12-05
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: BHV PHARMA Korlátolt Felelősségű Társaság

, Raktár utca 2. Székesfehérvár belterület, hrsz. 8199 „A" épület, 1. kapu; 1. ajtó, 3. és 4. raktár ajtók, Székesfehérvár, 8000, Hungary

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

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2. Authorised Wholesale Distribution Operation
2.2. Holding
2.2.1. Room temperature (15-25°C) store-house
2.2.2. Cold chain (2-8°C) store-house

Additional provisions based on national requirements

Name of responsible person: diploma No is:
Dr. Bánhidi Róbert 5/2002 (pharmacist)

*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	OGYÉI/60893-3/2018
	Page 1

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