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Report for the implementation of the goals for 2010 and ratified goals for 2011.
Charter and questionnaire form of the client
Issue of addendum to the Marketing Authorization for conduction of clinical trial of medicinal product in case of significant changes
Issue of Variation to a Marketing Authorization for wholesale of medicinal products
Issue of Marketing Authorization for wholesale of medical devices
Issue of Exemption Certificate of batch of pharmaceutical product under article 69 of the Law on Medicinal Products in Human Medicine (LMPHM)
Issue of Variation to a Certificate for registration of pharmacy
Issue of Registration Certificate for wholesale of medicinal products on the territory of the Republic of Bulgaria
Issue of Marketing Authorization for import of pharmaceutical products, active substances used as starting materials and medicinal products for clinical trial
Approval of non-interventional pharmaceutical clinical trial
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Register of vendors and producers
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ADMINISTRATION & DEPARTMENTS
Executive Director
Chief Secretary
Department «Legal, Administrative, Financial Activities and Quality Management»
Department «Marketing Authorisation of Medicinal Products»
Department «Market Supervision and Inspections»
Department «Pharmacovigilance and Clinical Trials»
Department «Control of Blood Transfusion System»
Department «Medicinal product analyses»
Department «Medicinal Products Information and Noninterventional Researches»
Finance controller
Citizens Menu
Warnings
Medicines
PRAC concludes review of medicines containing factor VIII
EMA reviews diabetes medicine canagliflozin
Over-the-Counter Drugs (OTC)
Pharmacovigilance / «Citizens»
Leuprorelin depot medicines: PRAC recommends new measures to avoid handling errors
Restrictions in use of cyproterone due to meningioma risk
PRAC confirms four-week limit for use of high-strength estradiol creams
PRAC recommends measures to minimise risk of serious side effects with Lemtrada for multiple sclerosis
PRAC recommends cautious use of Xeljanz for all patients at high risk of blood clots
PRAC recommends restricting use of prostate cancer medicine Xofigo
PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids
EMA reviewing risk of dosing errors with methotrexate - Review prompted by continued reports of overdose
Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone. Ongoing clinical study shows an increased risk of death and fractures with the combination
PRAC recommends updating measures for pregnancy prevention during retinoid use Warning on possible risk of neuropsychiatric disorders also to be included for all oral retinoids
EMA gives advice on the use of non-steroidal anti-inflammatories for COVID-19
PRAC recommends new measures to avoid dosing errors with methotrexate
PRAC concludes review of medicines containing factor VIII
PRAC investigates cancer medicine docetaxel
PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations Review finds evidence of gadolinium deposits in the brain after MRI body scans but no signs of harm
New review of valproate use in pregnancy and women of childbearing age
EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics
PRAC reviewing safety of pulmonary hypertension medicine Uptravi
PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation Risk may also apply to other medicines in the same class
EMA to review certain injectable medicines to treat allergy
Medicines
PRAC concludes review of medicines containing factor VIII
EMA reviews diabetes medicine canagliflozin
Over-the-Counter Drugs (OTC)
Pharmacovigilance
Leuprorelin depot medicines: PRAC recommends new measures to avoid handling errors
Restrictions in use of cyproterone due to meningioma risk
PRAC confirms four-week limit for use of high-strength estradiol creams
PRAC recommends measures to minimise risk of serious side effects with Lemtrada for multiple sclerosis
PRAC recommends cautious use of Xeljanz for all patients at high risk of blood clots
PRAC recommends restricting use of prostate cancer medicine Xofigo
PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids
EMA reviewing risk of dosing errors with methotrexate - Review prompted by continued reports of overdose
Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone. Ongoing clinical study shows an increased risk of death and fractures with the combination
PRAC recommends updating measures for pregnancy prevention during retinoid use Warning on possible risk of neuropsychiatric disorders also to be included for all oral retinoids
Administrative information
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MEASURES FOR PREVENTION OF WNV TRANSFUSION TRANSMISSION – 2019
EMA reviews multiple sclerosis medicine Zinbryta
PRAC investigates cancer medicine docetaxel
New review of valproate use in pregnancy and women of childbearing age
EMA starts review of retinoid medicines
Review of factor VIII medicines begins
Extension of the scope of a safety review
Practice run on public hearings
PRAC concludes review of Zydelig and issues updated recommendations for use EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Zydelig
EMA to review modified-release paracetamol
Medicines
PRAC concludes review of medicines containing factor VIII
EMA reviews diabetes medicine canagliflozin
Over-the-Counter Drugs (OTC)
Pharmacovigilance
PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids
New measures to avoid handling errors with leuprorelin depot medicines
Suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk
New testing and treatment recommendations for fluorouracil, capecitabine, tegafur and flucytosine
Restrictions in use of cyproterone due to meningioma risk
PRAC recommends measures to minimise risk of serious side effects with Lemtrada for multiple sclerosis
PRAC recommends cautious use of Xeljanz for all patients at high risk of blood clots
PRAC recommends new measures to avoid dosing errors with methotrexate
Fluoroquinolone and quinolone antibiotics: PRAC recommends restrictions on use
PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids
NCA for blood
MEASURES FOR PREVENTION OF WNV TRANSFUSION TRANSMISSION – 2022
MEASURES FOR PREVENTION OF WNV TRANSFUSION TRANSMISSION – 2021
NCA for blood
HOTLINES (right, vertical)
Important!
To the attention of all Marketing Authorisation Holders
Dear applicants,
To the attention of holders of marketing authorizations
Important!
From 01.01.2010 the submission of the documentation in electronic format - eCTD or NeeS is obligatory.
COVID-19
Administrative information
Over-the-Counter Drugs (OTC)
List of medicinal products under additional monitoring
EMA: Medicines under additional monitoring
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TO THE APPLICANTS, MARKETING AUTHORIZATION HOLDERS AND THEIR REPRESENTATIVES
TO ALL APPLICANTS, MARKETING AUTHORIZATION HOLDERS AND THEIR LOCAL REPRESENTATIVES
Marketing authorisation of medicinal products
Fees
Medical devices
Forms
Instructions to the submitters for preparation of a list of medical devices
Vigilance system
Guidelines
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Pharmacovigilance / «Companies»
Single, central platform now mandatory for all periodic safety update reports
Clinical trials
CTIS Highlights
Recommendations to the Sponsors for managing of Clinical Trials during the COVID-19 pandemic and the declared State of emergency in the Republic of Bulgaria
Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited"
Ethics Committee
Ethics Committee for Multicenter Trials
Control of the medicinal products
List of GMP inspectors and experts
Announcements - Medical devices
Гръдни импланти на френската фирма PIP (“Poly Implant Prothese”) – резултати от тестове
Блокиране на медицински изделия - дезинфекциращи кърпички на производителя “TRIAD GROUP”, САЩ
Доклад на EBA Europheresis Group
Гръдните импланти на френската фирма PIP (“Poly Implant Prothese”) – изтеглени от пазара
Pharmacopoeia
Announcements for pharmacovigilance
To the attention of all Marketing Authorisation Holders
EU regulations / «Pharmacovigilance»
"The rules governing medicinal products in the European Union" / Volume 9
BDA instructions / «Pharmacovigilance»
E-reporting / «Pharmacovigilance»
Reporting rules for MAHs/sponsors of CTs after 22nd November 2017
Expedited reporting requirements of the Bulgarian Drug Agency(BDA) for Individual Case Safety reports
CESP
Important!
COVID-19
Administrative information
Over-the-Counter Drugs (OTC)
List of medicinal products under additional monitoring
EMA: Medicines under additional monitoring
Публични оценъчни доклади
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