Source: http://convex.bg/useful-information/submission-process-for-medicinal-products/
Timestamp: 2018-02-19 15:31:37
Document Index: 542538621

Matched Legal Cases: ['art 1', 'art. 98', 'art. 86', 'art. 87', 'art 1', 'art 2', 'art. 98', 'art. 86', 'art. 87', 'art 1']

Submission Process for Medicinal Products – Convex Clinical Research
Convex Clinical Research
Dimitar Mirchev, MD, M.Sc.
Selection of Investigators and Clinical Sites
CRC and Phase I Unit
CRC Location
Submission Process for Medicinal Products
Submission Process for Medical Devices
Convex Office
Convex CRC
Convex Clinical Research / Useful Information / Submission Process for Medicinal Products
According to Bulgaria’s legislation (LMPHM and Regulation № 31), the submission of documents for a clinical trial approval of an investigational product shall be made to the Bulgarian Drug Agency (BDA) and Ethics Committee for Multicentre Trials (ECMT).
When the study is to be conducted at more than one site on the territory of the Republic of Bulgaria an application shall be submitted with the ECMT. When the study is to be conducted at one site on the territory of the Republic of Bulgaria an application may be submitted either at the respective Local Ethics Committee (LEC), or the ECMT. The application documents can be submitted to the BDA in parallel with the submission to the LEC/ECMT. Within 60 days (calendar days) after the submission of all documents, the Ethics Committee gives a written stand of approval or refusal of the clinical trial which is sent to the applicant and the BDA. The time frame for BDA’s approval after the submission of the study documents is up to 60 days. The clinical trial may start if within 60 days the BDA has not issued a notification with reasons for disapproval of the clinical trial.
See an illustration of the regulatory procedures in Bulgaria.
The following documents are needed for submission to BDA:
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 RAs and ECs outside Bulgaria where the application has been submitted and their decision
It should be mentioned if there was a negative standpoint, refusal or changes issued by the aforementioned authorities.
6. List of all sites, principal investigators and investigational staff proposed for the study on the territory of the Republic of Bulgaria
7. Copies of scientific advice received from EMEA, if applicable
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
12. Information for the patient/ subject – original and in Bulgarian
Should be provided site-specific information about the contact data of the principal investigator and the independent person for additional information
13. Informed Consent Form – original and in Bulgarian
14. Description of the procedures for enrollment of patients/subjects
15. Description of the procedures for obtaining an informed consent by a legal representative, if applicable
16. Ethical justification for enrollment of subjects incapable of giving an informed consent, in compliance with art. 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.)
17. Copy of any other information that shall be used for enrollment of subjects and/or given to subjects before or during a clinical trial – original and in Bulgarian
Study Protocol Documentation
18. Study Protocol with current amendments
19. Summary of the protocol in Bulgarian
20 Assessment of the scientific value of the study by an expert in the respective field, if available
21. Ethical evaluation of the protocol by the principal or coordinating investigator when it is not part of the protocol
22. The page of the protocol signed by the sponsor and the principal investigator
23. Case report form
Investigational Product Documentation
24. Investigator’s Brochure (IB), published not earlier than one year before the submission
If the IB is issued earlier than one year, the sponsor should provide a declaration with the current date of the overview, stating that no update is needed
25. Summary of all current clinical trials with the investigational product
26. The Summary of the Product Characteristics
It may be submitted instead of the IB when the investigational medicinal product has marketing authorization in a Member State of the European Union and the study envisages its use according the terms defined in the marketing authorization
27. Investigational medicinal product dossier
Documentation verifying the manufacturing of the investigational products in compliance with Good Manufacturing Practice
28. Declaration by the manufacturer if the investigational medicinal product is manufactured in EU and has a marketing authorization i.e. the product originates from a standard batch, manufactured in compliance with the terms of the marketing authorization, at the manufacturing site specified in the marketing authorization for an EU Member State
29. Copy of the manufacturing authorization for medicinal products under development and research (issued by an EU Member State) if the investigational medicinal product is manufactured in the European Union but does not have a marketing authorization
30. If the investigational medicinal product is not manufactured in the EU and does not have a marketing authorization:
Certification by the Qualified Person from the legal entity or person having import license for the territory of the European Union stating that the manufacturing, control and storage are in compliance with the standards equivalent to the requirements for Good Manufacturing Practice for medicinal products under development and research valid in EU
Copy of the import license for the territory of the European Union
31 Certificate of Good Manufacturing Practice for any active biological substance
32. Certificate of analysis of the investigational product in cases where impurities are not justified by the specification or when unexpected impurities are detected
33. Viral safety (if applicable)
34. TSE certificate (if applicable)
35. Labels in Bulgarian
Documentation regarding the Technical Requirements and the Personnel
36. Description of necessary equipment and/or technical requirements for implementation of the protocol
37. Documents verifying the present technical abilities for implementation of the protocol for each proposed site
38. Certificates for the reference values of the labs involved in the clinical trial and all parameters measured in the course of the study
39 CV and/or other documents verifying the education and qualification of the members of the investigational staff and their compliance with the requirements of art. 86, par. 2 of LMPHM
40. Document for the accreditation of the medical institution
41. Insurance covering the sponsor’s and principal investigator’s liability for injuries or damages to the subjects caused during or due to the conduct of the clinical trial
The original is required or copy designated with “True with Original”, signed and sealed (in Bulgarian language and with the general clauses included)
42. Information about indemnifications and compensations provided in event of injury or death of the subject during the conduct of the clinical trial
43. Agreement between the sponsor and the subjects in the study specifying the remuneration for participation, if applicable
44. Agreement between the sponsor and the investigator
45. Agreement between the sponsor and the medical institution – clinical study site
46. Written consent under art. 87, par. 3 of LMPHM (i.e. by the Director of the medical institution)
Submitted in original, referring to the title of the clinical study, principal investigator and the hospital department
47. Paid fee receipt.
The following documents are needed for submission to MCEC:
1. Covering letter in Bulgarian language
2. Application form part 1 and part 2 in Bulgarian
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 proposed for the study on the territory of the Republic of Bulgaria
6. Copies of scientific advice received from EMEA, if applicable
7. 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
8. Declaration which allows an access of the BDA inspectors to a third country
9. Declaration for identity of the contents of the documentation for the BDA and the EC
Document for current registration of the sponsor and the applicant on the territory of the European Union, issued by a competent authority
10. Information for the patient/ subject – original and in Bulgarian
11. Informed Consent Form – original and in Bulgarian
12. Description of the procedures for enrollment of patients/subjects
13. Description of the procedures for obtaining an informed consent by a legal representative, if applicable
14. Ethical justification for enrollment of subjects incapable of giving an informed consent, in compliance with art. 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.)
15. Copy of any other information that shall be used for enrollment of subjects and/or given to subjects before or during a clinical trial – original and in Bulgarian
16. Study Protocol with current amendments
17. Summary of the protocol in Bulgarian
18. Assessment of the scientific value of the study by an expert in the respective field, if available
19. Ethical evaluation of the protocol by the principal or coordinating investigator when it is not part of the protocol
20. The page of the protocol signed by the sponsor and the principal investigator
21. Investigator’s Brochure (IB), published not earlier than one year before the submission
22. Summary of all current clinical trials with the investigational product
23. The Summary of the Product Characteristics
24. Description of necessary equipment and/or technical requirements for implementation of the protocol
25. Documents verifying the present technical abilities for implementation of the protocol for each proposed site
26. Certificates for the reference values of the labs involved in the clinical trial and all parameters measured in the course of the study
27. CV and/or other documents verifying the education and qualification of the members of the investigational staff and their compliance with the requirements of art. 86, par. 2 of LMPHM
28. Document for the accreditation of the medical institution
29. Insurance covering the sponsor’s and principal investigator’s liability for injuries or damages to the subjects caused during or due to the conduct of the clinical trial
30. Information about indemnifications and compensations provided in event of injury or death of the subject during the conduct of the clinical trial
31. Agreement between the sponsor and the subjects in the study specifying the remuneration for participation, if applicable
32. Agreement between the sponsor and the investigator
33. Agreement between the sponsor and the medical institution – clinical study site
34. Written consent under art. 87, par. 3 of LMPHM (i.e. by the Director of the medical institution)
The following documents are needed for submission to LEC:
2. Application form part 1 and 2 in Bulgarian
15. Copy of any other information that shall be used for enrollment of subjects and/or given to subjects before or during a clinical trial – original and in Bulgarian language
35. Paid fee receipt.
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