ЗА ГРАЖДАНИТЕ
For citizens
For companies
For medical specialists
Top Menu
- …
- 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
- EMA gives advice on the use of non-steroidal anti-inflammatories for COVID-19
- Reporting suspected side effects of medicines in patients with COVID-19
- New measures to avoid handling errors with leuprorelin depot medicines
- CTIS Highlights
- PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids
- Site map
- Search
- Tags
MAIN MENU
- About BDA
- Legal acts
- Administrative services
- Issue of Marketing Authorization for conduction of clinical trial of medicinal product
- Issue of Marketing Authorization for production of pharmaceutical products, for active substances used as starting materials and for medicinal products for clinical trial
- Issue of Variation to a Marketing Authorization for wholesale of pharmaceutical products
- Issue of Marketing Authorization for wholesale of pharmaceutical products
- Issue of Marketing Authorization of pharmaceutical product via Decentralized Procedure
- Issue of Marketing Authorization of pharmaceutical product via Mutual Recognition Procedure
- Issue of Marketing Authorization of pharmaceutical product via National Procedure
- Issue of Certificate for pharmaceutical product
- Issue of Exemption Certificate of batch of pharmaceutical product under article 70 of the Law on Medicinal Products in Human Medicine (LMPHM)
- Issue of Certificate for the origin of the pharmaceutical product
- Issue of Certificate for registration of pharmacy
- Issue of registration certificate for homeopathic pharmaceutical product
- Issue of Registration Certificate for wholesale of pharmaceutical products on the territory of the Republic of Bulgaria
- Issue of Variation to a Registration Certificate for wholesale of pharmaceutical products on the territory of the Republic of Bulgaria
- Registration of medical devices
- Issue of report for information received in BDA for adverse drug reactions (ADR) for a pharmaceutical product
- Issue of Variation to a Marketing Authorization Type II to the Marketing Authorization of pharmaceutical product
- Issue of approval of pharmaceutical clinical trial
- Issue of Marketing Authorization for pharmaceutical clinical trial under art. 109 item 2 of the Law on Medicinal Products in Human Medicine (LMPHM)
- Issue of Marketing Authorization for significant change in a pharmaceutical clinical trial under art. 109 item 2 of the Law on Medicinal Products in Human Medicine (LMPHM)
- Approval of non-interventional pharmaceutical clinical trial
- Issue of Marketing Authorization for import of pharmaceutical products, active substances used as starting materials and medicinal products for clinical trial
- Issue of Registration Certificate for wholesale of medicinal products on the territory of the Republic of Bulgaria
- Issue of Variation to a Certificate for registration of pharmacy
- Issue of Exemption Certificate of batch of pharmaceutical product under article 69 of the Law on Medicinal Products in Human Medicine (LMPHM)
- Issue of Marketing Authorization for wholesale of medical devices
- Issue of Variation to a Marketing Authorization for wholesale of medicinal products
- Issue of addendum to the Marketing Authorization for conduction of clinical trial of medicinal product in case of significant changes
- Charter and questionnaire form of the client
- Report for the implementation of the goals for 2010 and ratified goals for 2011.
- 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»
- Announcements
- EMA reviews diabetes medicine canagliflozin
- PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation Risk may also apply to other medicines in the same class
- PRAC reviewing safety of pulmonary hypertension medicine Uptravi
- 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
- PRAC concludes review of medicines containing factor VIII
- EMA reviews multiple sclerosis medicine Zinbryta
- PRAC concludes there is no evidence of a change in the known risk of neutropenic enterocolitis cases with docetaxel
- EMA restricts use of multiple sclerosis medicine Zinbryta
- PRAC confirms restrictions on the use of linear gadolinium agents
- EMA seeks views of public during its safety review of valproate
- PRAC recommends that injectable methylprednisolone products containing lactose must not be given to patients allergic to cow's milk proteins
- PRAC recommends modified-release paracetamol be removed from market
- PRAC confirms its previous conclusion on risk of inhibitor development with factor VIII medicines
- EMA starts new review of hydroxyethyl-starch containing medicines
- EMA starts review of Esmya for uterine fibroids
- Warning about use of prostate cancer medicine Xofigo in combination with Zytiga and prednisone or prednisolone
- PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
- Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing
- PRAC recommends new measures to avoid valproate exposure in pregnancy New restrictions on use; pregnancy prevention programme to be put in place
- 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
- 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
- EMA reviewing risk of dosing errors with methotrexate - Review prompted by continued reports of overdose
- PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids
- PRAC recommends restricting use of prostate cancer medicine Xofigo
- PRAC recommends cautious use of Xeljanz for all patients at high risk of blood clots
- PRAC recommends measures to minimise risk of serious side effects with Lemtrada for multiple sclerosis
- PRAC confirms four-week limit for use of high-strength estradiol creams
- Restrictions in use of cyproterone due to meningioma risk
- Leuprorelin depot medicines: PRAC recommends new measures to avoid handling errors
- PRAC recommends restricted use for bromocriptine in inhibiting post-partum lactation
- PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig PRAC recommendations to be considered by CHMP for final opinion
- PRAC review does not confirm increase in heart problems with testosterone medicines Committee recommends medicines can continue to be given for their authorised uses
- PRAC recommends strengthening the restrictions on the use of valproate in women and girls Women to be better informed of the risks of valproate use during pregnancy
- PRAC recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)
- PRAC recommends updating advice on use of high-dose ibuprofen
- Review of Tysabri started
- Start of review of inhaled corticosteroids for chronic obstructive pulmonary disease
- EMA to further clarify safety profile of human papillomavirus (HPV) vaccines
- Start of review of nasal and mouth sprays containing fusafungine
- SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis
- Updated recommendations to minimise the risk of the rare brain infection PML with Tysabri
- EMA reviews direct-acting antivirals for hepatitis C
- PRAC reviews known risk of pneumonia with inhaled corticosteroids for chronic obstructive pulmonary disease
- Inhibitor development in previously untreated patients with severe haemophilia A treated with recombinant factor VIII products
- PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C
- EMA to review certain injectable medicines to treat allergy
- PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation Risk may also apply to other medicines in the same class
- PRAC reviewing safety of pulmonary hypertension medicine Uptravi
- EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics
- New review of valproate use in pregnancy and women of childbearing age
- 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
- PRAC investigates cancer medicine docetaxel
- PRAC concludes review of medicines containing factor VIII
- PRAC recommends new measures to avoid dosing errors with methotrexate
- Administrative information
Specialists Menu
- Announcements
- Announcements
- To the attention of healthcare professionals, patients and citizens
- European Medicines Agency starts review of ibuprofen medicines
- PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig PRAC recommendations to be considered by CHMP for final opinion
- PRAC review does not confirm increase in heart problems with testosterone medicines Committee recommends medicines can continue to be given for their authorised uses
- PRAC recommends strengthening the restrictions on the use of valproate in women and girls Women to be better informed of the risks of valproate use during pregnancy
- PRAC recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)
- PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines Medicines can still be given for their approved uses, with new restrictions
- PRAC recommends restrictions on the use of codeine for cough and cold in children
- PRAC recommends updating advice on use of high-dose ibuprofen
- Start of review of nasal and mouth sprays containing fusafungine
- Review concludes evidence does not support that HPV vaccines cause CRPS or POTS
- Updated recommendations to minimise the risk of the rare brain infection PML with Tysabri
- SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis
- EMA recommends new safety measures for Zydelig
- EMA reviews direct-acting antivirals for hepatitis C
- EMA reviewing gadolinium contrast agents used in MRI scans
- PRAC reviews known risk of pneumonia with inhaled corticosteroids for chronic obstructive pulmonary disease
- EMA reviews diabetes medicine canagliflozin
- EMA to review modified-release paracetamol
- PRAC concludes review of Zydelig and issues updated recommendations for use EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Zydelig
- Practice run on public hearings
- Extension of the scope of a safety review
- Review of factor VIII medicines begins
- EMA starts review of retinoid medicines
- New review of valproate use in pregnancy and women of childbearing age
- PRAC investigates cancer medicine docetaxel
- EMA reviews multiple sclerosis medicine Zinbryta
- MEASURES FOR PREVENTION OF WNV TRANSFUSION TRANSMISSION – 2019
- Pharmacovigilance
- Announcements
- Bulletins «Adverse drug reactions»
- PRAC recommends restrictions on the use of codeine for cough and cold in children
- Review of diabetes medicines called SGLT2 inhibitors started
- EMA recommends new safety measures for Zydelig
- EMA reviewing gadolinium contrast agents used in MRI scans
- Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function
- PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation Risk may also apply to other medicines in the same class
- PRAC reviewing safety of pulmonary hypertension medicine Uptravi
- 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
- PRAC concludes there is no clear and consistent evidence of a difference in inhibitor development between classes of factor VIII medicines
- PRAC confirms restrictions on the use of linear gadolinium agents
- EMA seeks views of public during its safety review of valproate
- PRAC recommends that injectable methylprednisolone products containing lactose must not be given to patients allergic to cow's milk proteins
- PRAC recommends modified-release paracetamol be removed from market
- PRAC confirms its previous conclusion on risk of inhibitor development with factor VIII medicines
- EMA starts new review of hydroxyethyl-starch containing medicines
- Warning about use of prostate cancer medicine Xofigo in combination with Zytiga and prednisone or prednisolone
- PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
- Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing
- PRAC recommends new measures to avoid valproate exposure in pregnancy New restrictions on use; pregnancy prevention programme to be put in place
- 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
- 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
- EMA reviewing risk of dosing errors with methotrexate - Review prompted by continued reports of overdose
- PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids
- Fluoroquinolone and quinolone antibiotics: PRAC recommends restrictions on use
- PRAC recommends new measures to avoid dosing errors with methotrexate
- PRAC recommends cautious use of Xeljanz for all patients at high risk of blood clots
- PRAC recommends measures to minimise risk of serious side effects with Lemtrada for multiple sclerosis
- Restrictions in use of cyproterone due to meningioma risk
- New testing and treatment recommendations for fluorouracil, capecitabine, tegafur and flucytosine
- Suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk
- 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
- Ethics Committee
- Ethics Committee for Multicenter Trials
- Control of the medicinal products
- Announcements - Medical devices
- Гръдните импланти на френската фирма PIP (“Poly Implant Prothese”) – изтеглени от пазара
- Доклад на EBA Europheresis Group
- Блокиране на медицински изделия - дезинфекциращи кърпички на производителя “TRIAD GROUP”, САЩ
- Гръдни импланти на френската фирма PIP (“Poly Implant Prothese”) – резултати от тестове
- Pharmacopoeia
- Announcements for pharmacovigilance
- EU regulations / «Pharmacovigilance»
- BDA instructions / «Pharmacovigilance»
- E-reporting / «Pharmacovigilance»
- CESP
