BALGARSKA RADIOFARMATSEVTICHNA KOMPANIYA OOD
Болгарский фармацевтический производитель, лицензированный национальным агентством по лекарственным средствам.
Болгарское агентство по лекарственным средствам вносит эту компанию в свой реестр разрешений на производство под разрешением BG/MIA-0581, выданным 29 июня 2026 г. Разрешение распространяется на стерильные лекарственные средства. Зарегистрированное название в национальном реестре: БЪЛГАРСКА РАДИОФАРМАЦЕВТИЧНА КОМПАНИЯ ООД.
- Type
- Manufacturer
- Location
- Bulgaria
- Categories
- Фармацевтическое производство, Медицинские товары и расходники
- Markets
- Болгария
Listed in a source registry
Bulgarian Drug Agency (ИАЛ), registers of manufacturers, importers and traders
Verified facts
- operating-permit (green), checked 2026-08-20 Bulgarian Drug Agency (Изпълнителна агенция по лекарствата), register of manufacturing and import authorisations under art. 19 of the Medicinal Products Act
- registered-manufacturer (green), checked 2026-08-20 Bulgarian Drug Agency (Изпълнителна агенция по лекарствата), register of manufacturing and import authorisations under art. 19 of the Medicinal Products Act
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
- Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)