Fri 6 Nov 2026 13:12:51 BST

Search Company

OMS Organisation Identifier:

OMS Location Identifier:

NCA Reference Key:

Address:

Country:

Active Substance

New Active Substance

Search Site

Create Site

Update Site

Current data stored in EudraGMDP database

Current data stored in OMS

DUNS Number:

NCA Reference Key:

Site Name:

OMS Organisation Identifier:

OMS Location Identifier:

Address Line 1:

Address Line 2:

Address Line 3:

Address Line 4:

City:

County:

Postcode:

Country:

Additional Details on Units Inspected

Site under Compliance Management:

Compliance Management comments:

Characters remaining:4000/4000

Overwrite with current OMS data.:

New Active Substance Importation

Active Substance*

Active Substance (English):
Active Substance (NL):
NCA Reference Key:

3rd Country Manufacturer

3rd Country Manufacturer	OMS Location Identifier	OMS Organisation Identifier	Legal Address	NCA Reference Key	Confidential	Edit	Delete
No records found.

3rd Country Distributor

3rd Country Distributor	OMS Location Identifier	OMS Organisation Identifier	Legal Address	NCA Reference Key	Confidential	Edit	Delete
No records found.

RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	HU-D-TEVA
2. Name of Authorisation Holder	:	Teva Gyógyszergyár Zártkörűen Működő Részvénytársaság
3. Address(es) of Site(s)	:	Vasút u. 11. (Shark Park) SPH4 és SPH5 Raktárépület, 2-14. kapuk, Budaörs, 2040, Hungary

4. Legally registered address of Authorisation Holder	:	Pallagi út 13, Debrecen, 4042, 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	:	2021-10-06
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: Teva Gyógyszergyár Zrt.

, Vasút u. 11. (Shark Park) SPH4 és SPH5 Raktárépület, 2-14. kapuk, Budaörs, 2040, 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

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: see in restriction part

Any restrictions or clarifying remarks (for all users): Other authorized products with additional requirements:
2.2 Holding
2.2.1 Room temperature (15-25°C) store-house
2.2.2 Cool temperature (8-15°C) warehouse SHP5, room C29A; warehouse SHP5, room C29B
2.2.3 Materials for preparation of „magistral formula" (2-8°C)
3. Other permitted medicinal products
3.4.1. Homeopathic medicinal products
3.4.2. Materials for preparation of „magistral formula" (human medicinal products)

Additional provisions based on national requirements:
Responsible Person is: diploma No is:
Dr. Alapi Anikó 1/1990 (pharmacist)
Dr. Ungor Enikő GYTK-00054/2019/OKL (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-TEVA
	Page 1

Loading, please wait