BACR
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Bulgarian Legislation

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  • About clinical trials
About clinical trials
  • International Acts
  • EU Legislation
  • Bulgarian Legislation
  • Useful links
  • Recommendations and Instructions

Bulgarian Legislation

Constitution of The Republic of Bulgaria - Art. 29, para 2

Medical Devices Act (19.02.2016)

Medicinal Products in Human Medicine Act (07.06.2016)

ORDINANCE on the Essential Requirements and the Procedures for Conformity Assessment to the Essential Requirements for Medical Devices Referred to in Article 2, paragraph 1 (3) of the Medical Devices Act

ORDINANCE № 10 of 2008 on the Documents Required from the principal/Coordinating Investigator or Sponsor for Obtaining an Ethics Committee Statement and on the Procedure for Safety Monitoring of Medical Devices during Clinical Investigations and Assessment of the Clinical Data Collected during such Investigations

Personal Data Protection Act

In brief
WE ARE

Bulgarian Association of Clinical Research (BACR) is a voluntary and independent non-governmental organisation, founded in 2003 in Sofia, Bulgaria. It is a local organisation representing the interests of pharmaceutical companies, contract research organisations (CROs) and professionals, involved in the field of clinical research in Bulgaria

Learn more

GSM:

+359 897 97 19 55

  • IBAN: BG 08 UNCR 7630 1077 47 1828

  • BIC: UNCRBGSF

  • Уникредит Булбанк АД

  • БУЛСТАТ: 131154353

  • МОЛ: д-р Борислав Борисов

  • bacr@bacr-bg.com

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BACR

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