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Law, Regulation or Guideline
Record information and status
Record ID
Date of creation
2014-03-07 10:06 UTC (tsultanova@moew.government.bg)
Date of last update
2019-08-01 10:53 UTC (ntsvetkov@moew.government.bg)
Date of publication
2019-08-01 10:53 UTC (ntsvetkov@moew.government.bg)

General Information
  • Bulgaria
  • Bulgaria
Title of document
Medicinal Products in Human Medicine Act
Legislative details
Type of document
  • Law
Subject areas
  • Human and/or Animal Health
  • Pharmaceuticals
Types of LMOs addressed
  • All types of organisms
Brief description of the document including objective and scope:
The Medicinal Products in Human Medicine Act regulates:
1. authorisation for use or registration of medicinal products designated for the human medicine, which are industrially manufactured or the manufacturing method, which includes industrial process;
2. authorisation of manufacturing and import of medicinal products;
3. manufacturing, import and wholesale trade with active substances;
4. approval and conducting clinical trials;
5. wholesale of and retail trade in medicinal products;
6. parallel import of medicinal products;
7. intermediation in the area of medicinal products;
8. export of medicinal products according to the provisions of Chapter 9b;
9. advertising medicinal products;
10. follow-up of the safety of the medicinal products released on the market;
11. classification of the method of prescribing and dispensing medicinal products;
12. control of the manufacture and import, wholesale and retail trade, conducting clinical trials, advertising, and the system for the follow-up of the safety the medicinal products released on the market;
13. pricing of medicinal products;
14. development of Positive Medicines List.

The Act aims to create conditions for providing the release on the market of medicinal products, which comply with the requirements relating to quality, safety, and efficacy.
Date of entry into force
Document details
Information about document text
The translation in English is not official.
Тhe version uploaded is current as of 1 August 2019.
Regulatory contact information
Contact person
Ministry of Health
5 Sveta Nedelia Sq
Bulgaria, 1000
Phone:+359 2 93 01 271
Fax:+359 2 988 34 13
Url:Ministry of Health
Additional Information
Other relevant website address or attached documents