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Bulgaria Drug Product Registration

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Bulgaria Drug Product Registration

Safeguarding Public Health Through Comprehensive Regulation

Ministry of Health 

Ministry of Health Republic of Bulgaria

MoH Website

https://www.mh.government.bg/en/

Regulatory Agency

Bulgaria Drug Agency, BDA

Regulatory Agency Website

https://www.bda.bg/en/

Fees

Marketing Authorization Validity

5 Years

Renewal of Marketing Authorisation

9 months before expiry date

After the first renewal, marketing authorisations are valid for an indefinite term. In the event of duly justified reasons related to pharmacovigilance, the BDA may require an additional 5 (five) year renewal.

Overview

  • Manufacturers need to get authorizations from the Bulgarian Drug Agency, which is overseen by the Ministry of Health in Bulgaria, to obtain market access.
  • Anywhere in the EU, an authorized representative is needed for entry into the region and without the updated Bulgarian Regulatory knowledgebase navigating through the complex Regulatory procedures might be an uphill task for new market entrants.
  • The Bulgarian Drug Agency (BDA) is a specialized the state regulatory body that oversees the efficacy, safety, and quality of pharmaceuticals (including biological medicines) and medical devices.
  • The BDA is responsible for authorizing and registering medicinal products and medical devices launching in the market.
  • The Food and Drug Administration (FDA) of the United States confirms to BDA’s capacity to conduct inspections for good manufacturing practices at a level equivalent with that of the US.

Drug Registration Procedure

  • These are applicable for new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products
  • Homeopathic products and traditional herbal medicinal products may be placed on the market in Bulgaria based on a registration certificate.
  • All other medicinal products may be placed on the market subject to the obtaining of a marketing authorisation.
  • Only marketing authorisation holders whose place of residence or seat is located in a Member State of the European Economic Area can apply for the marketing authorisation.
  • A marketing authorization given via any of the following procedures at the European Medicines Agency (EMA).
  1. National Procedure;
  2. Decentralized Procedure
  3. Mutual Recognition Procedure
  4. Centralized Procedure

1. National Procedure

  • The marketing authorisation is issued by the Executive Director of the BDA based on submission of application and proper documentation, in Bulgarian and/or English language – the dossier is filed in e-CTD format.
  • The application follows a standard-form template and may be submitted by an individual or a legal company established in European Economic Area (EEA), whereas, If the applicant is not from Bulgaria, an authorized representative must be designated to represent before the Bulgarian regulatory authorities must be appointed.
  • The marketing authorisation is granted subject to fulfilment of all applicable legal requirements aiming at providing scientific proof for the quality, safety and therapeutic efficacy of the medicinal product.

  1. Decentralized Procedure (DCP)

  • The application for the issuance of a marketing authorisation is filed simultaneously with the BDA and with the regulatory bodies of other member states, where the product is intended for marketing.
  • The applicant must indicate the state, which shall be the reference member state (RMS) leading the evaluation procedure. The applicant needs to specify which are the other concerned member states (CMS).
  • The BDA have limited capacity to act as RMS and Bulgaria is usually appointed as CMS.
  • The e-CTD format is used for submitting the product dossier.
  • As a result of the process, the BDA, RMS, and the remaining CMS members issue a marketing authorization for Bulgaria along with the approved summary of product characteristics (SPC), patient information leaflet, and packaging mock-up (collectively referred to as the product information or PI).

  1. The Mutual Recognition Procedure (MRP)

  • It is identical to DCP, however in this case the product has already received approval in EEA state, and the MAH further applies to authorize this same product for marketing in other countries – CMS.
  • Again, usually BDA acts on the CMS side.
  • The applicant must submit the identical product dossier, as such is provided to the reference member state (RMS) and concerned member states (CMS).
  • Again, the outcome of the procedure is that the BDA (along with the rest of the CMS) issues a marketing authorisation for Bulgaria along with the authorised PI.
  • The main difference between the DCP and MRP and the centralized method, which results in a single marketing authorization for each member state, is that the former leads to multiple national marketing authorizations.

  1. Centralized Authorisation Procedure

  • Pharmaceutical companies only submit one application to EMA for marketing authorization.
  • This enables the holder of the marketing authorization to sell the pharmaceuticals across the European Economic Area (EEA) using a single marketing authorization given by the European Commission. For some types of medical goods, the centralized method is required; for other types of medicinal products, it is optional.
  • Certain medicinal products are not suitable for this procedure.

Authorisation Process for the Marketing of Generic Products

  • The same authorization process is used for generic drugs to gain marketing authorization; however, the applicant is not required to present findings and documentation of the clinical and preclinical data and must instead demonstrate bioequivalence with the reference medicinal product.
  • Only when the data exclusivity period has passed—typically ten years from the date of the initial authorization—would the generic application result in marketing authorization.

Submission Process for Medicinal Products

  • According to Bulgaria’s legislation (LMPHM law and Regulation № 31), the submission of documents for a clinical study approval of an investigational product shall be made to the Bulgarian Drug Agency (BDA) and Ethics Committee for Multicenter Trials (ECMT).
  • The applicant and the BDA get a formal statement from the Ethics Committee indicating their approval or disapproval of the clinical research within 60 (calendar) days of all documentation being submitted.
  • After the research materials are submitted, BDA might approve the request within a maximum of 60 days. If, after 60 days, the BDA has not sent out a letter outlining its reasons for disapproving the clinical study, then the experiment may begin.

The following documents are needed for submission to Bulgarian Drug Agency BDA:

Administrative Documentation

  1.   Covering letter in Bulgarian
  2.  Application form part 1 in Bulgarian and English
  3.  Application in xml-format
  4. Confirmation of the EudraCT number
  5. List of foreign RAs and ECs to whom the application has been sent, together with their determination. If the aforementioned authorities had any unfavorable opinions, rejected proposals, or issued any amendments, it should be indicated.
  6. List of all sites, principal investigators and investigational team members suggested for the study inside the territory of the Republic of Bulgaria.
  7.  If applicable, Copies of scientific advice received from EMEA,
  8. Letter of Intent or Agreement for authorization of the person submitting the application on behalf of the sponsor, when the applicant is not the sponsor
  9. Document for current registration of the sponsor and the applicant on the territory of the European Union, issued by a competent authority
  10. Declaration which allows an access of the BDA inspectors to a third country
  11. Declaration for identity of the contents of the documentation for the BDA and the EC

Information for the Subject

  1.   Information for the patient/ subject – original and in Bulgarian
  2.  Informed Consent Form – original and in Bulgaria
  3.  Description of the procedures for enrollment of patients/subjects
  4. If applicable, Description of the procedures for obtaining an informed consent by a legal representative.
  5. Ethical justification for enrollment of subjects unable of giving an informed consent, in compliance with article. 98 of LMPHM In case of detailed description of the procedures and justification (14, 15 ,16) in another document (i.e. the study protocol), it could be referred to the latter (chapter, page, etc.).
  6. Copy of any additional information that will be used for enrollment of participants and/or given to participants before or during a clinical trial – original and in Bulgarian.

Study Protocol Documentation

  1. Study Protocol with current amendments
  2. Summary of the protocol in Bulgarian
  3. Assessment of the scientific value of the study by an expert in the respective field, if available
  4. Ethical evaluation of the protocol by the principal or coordinating investigator when it is not part of the protocol
  5. The page of the protocol signed by the sponsor and the principal investigator
  6. Case report form

    Investigational Product Documentation

    1. Investigator’s Brochure (IB) published no earlier than one year before submission. If the IB is issued earlier than one year, the sponsor must provide a declaration with the overview’s current date, stating that no update is needed.
    2. Summary of all current clinical trials with the investigational product.
    3. The Summary of the Product Characteristics.
    4. Dossier for investigational medicinal products documentation verifying that the investigational products were manufactured in accordance with good manufacturing practices.
    5. If the investigational medicinal product is made in the European Union and has a marketing authorization, the manufacturer must declare this. This means that the product comes from a standard batch and is made at the manufacturing site listed in the marketing authorization for an EU Member State, in accordance with the terms of the authorization.
    6. If an experimental medicine is manufactured in the European Union but lacks a marketing authorization, a copy of the manufacturing authorization for the product (given by an EU Member State) is required.
    7. If the experimental drug is not produced in the European Union and lacks a marketing authorization:
      • Certification that the manufacturing, control, and storage comply to standards equal to the requirements for Good Manufacturing Practice for medicinal products under development and research that are valid in the EU, provided by the Qualified Person from the legal entity or person holding an import license for the territory of the European Union.
      • A copy of the import permit valid for use inside EU borders.
    8. Certificate of Good Manufacturing Practice for any active biological substance
    9. Certificate of analysis of the investigational product in cases where impurities are not justified by the specification or when unexpected impurities are detected
    10. Viral safety (if applicable)
    11. TSE certificate (if applicable)
    12. Labels in Bulgarian language

Documentation regarding the Technical Requirements and the Personnel

  1.   Description of necessary equipment and/or technical requirements for implementation of the protocol.
  2.  Documents verifying the current technical capabilities for implementation of the protocol for each proposed site
  3.  Certificates for the reference values of the labs participating in the clinical trial and all parameters measured in the study.
  4.  CV and/or other documents verifying the education and qualification of the members of the investigational staff and their compliance with the requirements of article. 86, paragraph 2 of LMPHM.
  5.  A document related to the medical institution’s accreditation.

Financial and Administrative Documentation

  1. Insurance covers the sponsor’s and principal investigator’s liability for injuries or damage to the subjects caused during or due to the conduct of the clinical trial. The original must be submitted, or copy marked with “True with Original”, signed and sealed (in Bulgarian language and with general clauses included).
  2. Information about indemnifications and compensations provided in case of injury or death of the subject during the conduct of the clinical studies.
  3. Contract between the sponsor and the subjects in the study specifying the remuneration for participation, if applicable.
  4. Contract between the sponsor and the investigator.
  5. Contract between the sponsor and the medical institution – clinical study site.
  6. Written consent under article 87, paragraph 3 of LMPHM (i.e. by the Director of the medical institution) Submitted in original, referring to the title of the clinical trial, principal investigator and the hospital department
  7. Paid fee receipt.
  8. The following documents required for submission to MCEC:

Administrative Documentation

  1. Covering letter in Bulgarian language.
  2. Application form part 1 and part 2 in Bulgaria language.
  3. Confirmation of the EudraCT number.
  4. List of RAs and ECs outside Bulgaria where the application has been submitted and their decision.
  5. List of all sites, principal investigators and investigational staff used for the study on the territory of the Republic of Bulgaria
  6. If applicable, Copies of scientific advice received from EMEA.
  7. Letter of Intent or Agreement for authorization of the person submitting the application on sponsor’s behalf, when the applicant is not the sponsor.
  8. Declaration which allows access of the BDA inspectors to a third nation.
  9. Declaration for verifying the contents of the documentation for the BDA and EC. Document for current registration of the sponsor and the applicant on the territory of the EU, issued by a competent authority.

Information for the Subject

  1. Information of the patient or subject, in Bulgarian. Should be provided site-specific information about the contact details of the principal investigator and the independent person for additional information.
  2. The original Informed Consent Form in Bulgarian.
  3. A description of the patient/subject enrolling procedures.
  4. If applicable, A description of the steps involved in obtaining a legal representative’s informed permission.
  5. According to LMPHM Article 98, the registration of persons who are unable to give informed permission is justified ethically. If the research protocol has a more thorough explanation of the processes and reasoning (14, 15, 16, etc.), it may be referenced to in that document (chapter, page, etc.).
  6. Original and in Bulgarian, any other information that shall be used for enrollment of subjects and/or given to subjects before or during a clinical trial.

Study Protocol Documentation

  1. Study Protocol with current amendments
  2. Summary of the protocol in Bulgarian language.
  3. Assessment of the scientific value of the study by an expert in the respective field, if available.
  4. Ethical evaluation of the protocol by the principal or coordinating investigator when it is not part of the protocol.
  5. The page of the protocol signed by the sponsor and the principal investigator.

Investigational Product Documentation

  1. A year before submission, the Investigator’s Brochure (IB) must be released. If the IB is granted before a year has passed, the sponsor is required to provide a statement declaring that there is no need for an update and providing the current overview date.
  2. A list of all ongoing clinical studies involving the experimental product.
  3. The Product Characteristics Summary. When the investigational medicinal product has a marketing license in a Member State of the European Union and the research envisions using it in accordance with the guidelines outlined in the marketing authorization, it may be submitted in place of the IB.

Technical Requirements and the Personnel Documentation

  1. Description of necessary equipment and/or technical requirements for implementation of the protocol.
  2. Documents verifying the current technical capabilities for implementation of the protocol for each proposed site
  3. Certificates for the reference values of the labs participating in the clinical trial and all parameters measured in the study.
  4. CV and/or other documents verifying the education and qualification of the members of the investigational staff and their compliance with the requirements of article. 86, paragraph 2 of LMPHM.
  5. A document related to the medical institution’s accreditation.

Financial and Administrative Documentation

  1. Insurance covers the sponsor’s and principal investigator’s liability for injuries or damage to the subjects caused during or due to the conduct of the clinical trial. The original must be submitted, or copy marked with “True with Original”, signed and sealed (in Bulgarian language and with general clauses included).
  2. Information about indemnifications and compensations provided in case of injury or death of the subject during the conduct of the clinical studies.
  3. Contract between the sponsor and the subjects in the study specifying the remuneration for participation, if applicable.
  4. Contract between the sponsor and the investigator.
  5. Contract between the sponsor and the medical institution – clinical study site.
  6. Written consent under article 87, paragraph 3 of LMPHM (i.e. by the Director of the medical institution) Submitted in original, referring to the title of the clinical trial, principal investigator and the hospital department

The following documents required for submission to LEC:

Administrative Documentation

  1. Covering letter in Bulgarian language.
  2. Application form part 1 and part 2 in Bulgaria language.
  3. Confirmation of the EudraCT number.
  4. List of RAs and ECs outside Bulgaria where the application has been submitted and their decision.
  5. List of all sites, principal investigators and investigational staff used for the study on the territory of the Republic of Bulgaria
  6. If applicable, Copies of scientific advice received from EMEA.
  7. Letter of Intent or Agreement for authorization of the person submitting the application on sponsor’s behalf, when the applicant is not the sponsor.
  8. Declaration which allows access of the BDA inspectors to a third nation.
  9. Declaration for verifying the contents of the documentation for the BDA and EC. Document for current registration of the sponsor and the applicant on the territory of the EU, issued by a competent authority.

Information for the Subject

  1. Information of the patient or subject, in Bulgarian. Should be provided site-specific information about the contact details of the principal investigator and the independent person for additional information.
  2. The original Informed Consent Form in Bulgarian.
  3. A description of the patient/subject enrolling procedures.
  4. If applicable, A description of the steps involved in obtaining a legal representative’s informed permission.
  5. According to LMPHM Article 98, the registration of persons who are unable to give informed permission is justified ethically. If the research protocol has a more thorough explanation of the processes and reasoning (14, 15, 16, etc.), it may be referenced to in that document (chapter, page, etc.).
  6. Original and in Bulgarian, any other information that shall be used for enrollment of subjects and/or given to subjects before or during a clinical trial.

Study Protocol Documentation

  1. Study Protocol with current amendments
  2. Summary of the protocol in Bulgarian language.
  3. Assessment of the scientific value of the study by an expert in the respective field, if available.
  4. Ethical evaluation of the protocol by the principal or coordinating investigator when it is not part of the protocol.
  5. The page of the protocol signed by the sponsor and the principal investigator.

Investigational Product Documentation

  1. A year before submission, the Investigator’s Brochure (IB) must be released. If the IB is granted before a year has passed, the sponsor is required to provide a statement declaring that there is no need for an update and providing the current overview date.
  2. A list of all ongoing clinical studies involving the experimental product.
  3. The Product Characteristics Summary. When the investigational medicinal product has a marketing license in a Member State of the European Union and the research envisions using it in accordance with the guidelines outlined in the marketing authorization, it may be submitted in place of the IB.

Technical Requirements and the Personnel Documentations

  1. Description of necessary equipment and/or technical requirements for implementation of the protocol.
  2. Documents verifying the current technical capabilities for implementation of the protocol for each proposed site
  3. Certificates for the reference values of the labs participating in the clinical trial and all parameters measured in the study.
  4. CV and/or other documents verifying the education and qualification of the members of the investigational staff and their compliance with the requirements of article. 86, paragraph 2 of LMPHM.
  5. A document related to the medical institution’s accreditation.

Financial and Administrative Documentation

  1. Insurance covers the sponsor’s and principal investigator’s liability for injuries or damage to the subjects caused during or due to the conduct of the clinical trial. The original must be submitted, or copy marked with “True with Original”, signed and sealed (in Bulgarian language and with general clauses included).
  2. Information about indemnifications and compensations provided in case of injury or death of the subject during the conduct of the clinical studies.
  3. Contract between the sponsor and the subjects in the study specifying the remuneration for participation, if applicable.
  4. Contract between the sponsor and the investigator.
  5. Contract between the sponsor and the medical institution – clinical study site.
  6. Written consent under article 87, paragraph 3 of LMPHM (i.e. by the Director of the medical institution) Submitted in original, referring to the title of the clinical trial, principal investigator and the hospital department.

Paid fee receipt.

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