Eudra GMP - Public Layout

MIA | GMP | API REG | WDA | GDP | Sites

Help

Sat 24 Oct 2026 16:09:18 BST

GMP Compliance Menu

GMP Certificates

Non-Compliance Report

Print Preview

Print Preview (Short version)

Back To Search

Bulgarian Drug Agency

CERTIFICATE NUMBER: BG/GMP/2025/327

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Bulgaria confirms the following:

The manufacturer: BB NCIPD EAD

Site address:

Bulevard Yanko Sakizov 26, Sofia, Oblast Sofia, 1504, Bulgaria

OMS Organisation Id. / OMS Location Id.: ORG-100001319 / LOC-100004095

Has been inspected under the national inspection programme in accordance with Art. 40 of Directive 2001/83/EC.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2025-10-08 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (3)

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). This certificate is valid only when presented with all pages and both Parts 1 and 2.

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 111(5) of Directive 2001/83/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

Part 2

Human Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.2  Lyophilisates
           1.1.1.4  Small volume liquids
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.3  Small volume liquids
   1.1.3  Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.2  Immunological products
   1.3.2  Batch Certification (list of product types)
           1.3.2.2  Immunological products

1.5 Packaging

1.5.2 Secondary packaging

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.2  Microbiological: non-sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

Clarifying remarks (for public users):

Authorised operations activities referred to in paragraph 1.3.1.2 include: “bulk” manufacturing. Primary, secondary packaging, certification and release of medicinal products is performed at manufacturing premises of BB-NCIPD EAD, located at 26 Yanko Sakazov Blvd. 1504 Sofia, Bulgaria; The manufacture of PPD Tuberculin mammalian includes full manufacturing process; Manufacture of biological active starting materials; p. 1.1.1, p. 1.1.1.2, p. 1.1.1.4, p. 1.1.3, p. 1.3.1, p. 1.3.1.2, p. 1.3.2, p. 1.3.2.2, p. 1.5 and point Quality control testing also refers to the newly introduced “BCG Vaccine Laboratoty” on first floor of the building; Based on the risk assessment, the validity of GMP certificate is restricted to two years of the date of inspection written in this certificate. This certificate replaces certificate № BG/GMP/2025/326.

The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, they are no longer included or updated from 1 January 2021, with the exception of the documents pertaining to sites located in Northern Ireland.