Please explore our additional resources for information about clinical research in Bulgaria and at Convex.
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We at Convex value tradition and adopt what has proven effective. Yet we also appreciate innovation and we are passionate about keeping ourselves up-to-date.
Regulatory Links
Bulgaria has modern legislation prepared with active compliance to the European Union (EU) directives and regulations in order to ensure the safety and well-being of its citizens. For furhter ...
Legislation
The following legislation sets out the requirements for conducting clinical trials of medicinal products and medical devices in Bulgaria and is fully harmonized with the EU Directives:
Submission Process for Medicinal products
According to Bulgarian legislation (LMPHM and Regulation 31), submission of documents for clinical trial approval of an investigational drug shall be made to the Bulgarian Drug Agency ( BDA) and ...
Submission Process for Medical devices
According to Bulgarian legislation (LMD and the relevant regulations), submission of documents for clinical trial approval of a medical device shall be made to the Bulgarian Drug Agency (BDA) and the ...
Import from third countries
An Import License for medicinal products subject to clinical research and imported from third countries is issued by the Bulgarian Drug Agency (BDA) to people registered as tradesmen according to ...


