For citizens
For companies
For medical specialists
Top Menu
MAIN MENU
- About BDA
- Legal acts
- Administrative services
- 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
- Registers
- Useful links
- Contacts
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
- 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
- Administrative information
Specialists Menu
- Announcements
- 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
- Pharmacovigilance
- 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
HOTLINES (right, vertical)
Companies menu
- Information for companies
- Announcements for companies
- Marketing authorisation of medicinal products
- Medical devices
- Medicinal information
- Linguistic check
- Pharmacovigilance / «Companies»
- 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
- 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
- EU regulations / «Pharmacovigilance»
- BDA instructions / «Pharmacovigilance»
- E-reporting / «Pharmacovigilance»
- CESP
