Thu 29 Oct 2026 23:20:33 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

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	GIF-N-4111/146/PŁ/10
2. Name of Authorisation Holder	:	Bioton S.A. (ORG-100000293 / LOC-100001059)
3. Address(es) of Site(s)	:	Ul. Poznanska 12, Macierzysz, Ozarow Mazowiecki, Mazowieckie, 05-850, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Poznanska 12, Macierzysz, Ozarow Mazowiecki, Mazowieckie, 05-850
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	:	2026-06-22
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: Bioton S.A.

(ORG-100000293 / LOC-100001059)

, Ul. Poznanska 12, Macierzysz, Ozarow Mazowiecki, Mazowieckie, 05-850, Poland

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): Przedmiotem obrotu w hurtowni farmaceutycznej są w szczególności produkty lecznicze, dla których podmiotem odpowiedzialnym jest Bioton S.A.Hurtownia Bioton S.A. prowadzi również obrót produktami leczniczymi wymienionymi poniżej, w szczególności:
Nazwa powszechnie stosowana
Chondroitini natrii sulfas
Insulinum glarginum

Nazwa produktu leczniczego
CARTEXAN
Semglee

Postać farmaceutyczna
Kapsułki twarde
Roztwór do wstrzykiwań we wstrzykiwaczu

Union Format for a Wholesale Distribution Authorisation	GIF-N-4111/146/PŁ/10
	Page 1

Loading, please wait