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RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-MEDT
2. Name of Authorisation Holder	:	MEDITOP Gyogyszeripari Kft. (ORG-100001038 / LOC-100000728)
3. Address(es) of Site(s)	:	Ady Endre Utca 1, Pilisborosjeno, 2097, Hungary

4. Legally registered address of Authorisation Holder	:	Ady Endre Utca 1, Pilisborosjeno, 2097
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	:	2023-06-15
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: MEDITOP Gyogyszeripari Kft.

(ORG-100001038 / LOC-100000728)

, Ady Endre Utca 1, Pilisborosjeno, 2097, Hungary

Human medicinal products

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

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: see in restriction part

Any restrictions or clarifying remarks (for all users): Any restrictions or clarifying remarks (for all users):
3.3. Cold chain products 2-8 °C
3.4. Drugs with special storage conditions 8-15°C
Additional provisions based on national requirements
Name of responsible person:            diploma No :
       Dr. Pecze Melinda                  74/1995 (pharmacist)
       Dr. Gál Lívia                          28/1987 (pharmacist)
       Dr. Szegvári Dávid                 82/2001 (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	HU-D-MEDT
	Page 1

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