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About

State institutions of the republic of Bulgaria

Parliament

http://www.parliament.bg

Council of Ministers

Administrative registry at the Council of Ministers

http://www.government.bg

http://ar2.government.bg/ras

Ministry of Health

http://www.mh.government.bg

European institutions

Gateway to the European Union (The official site of the European Union)

http://www.europa.eu/

European Commission

http://www.ec.europa.eu/

European Medicines Agency (EMA)

http://www.ema.europa.eu/ema/

European Directorate for the Quality of Medicines and Healthcare, Strasbourg

http://www.edqm.eu

European medicines regulatory agencies

Austria

Bundesamt für Sicherheit im Gesundheitswesen

www.ages.at

Belgium

Directoraat generaal Geneesmiddelen

Direction générale Médicaments

www.afigp.fgov.be

Bulgaria

Institute for Control of Veterinary Medicinal Preparations

United Kingdom (H)

Medicines and Healthcare products Regulatory Agency

www.mhra.gov.uk

United Kingdom (V)

Veterinary Medicines Directorate

www.vmd.gov.uk

Germany (H)

Bundesministerium für Gesundheit und Soziale Sicherung

Bundesinstitut für Arzneimittel und Medizinprodukte

Paul-Ehrlich-Institut

https://www.bmg.bund.de/

www.bfarm.de

www.pei.de

Germany (V)

Bundesministerium für Verbrauerschutz, Ernahrung und Landwirtschaft

Bundesministerium für Verbraucherschutz und Lebensmittelsicherheit (Veterinary medicinal products)

www.bmvel.bund.de

www.bvl.bund.de

Germany (H+V)

Zentralstelle der Länder für Gesundheitsschutz bei

Arzneimitteln und Medizinprodukten

www.zlg.nrw.de

Greece

National Organisation for Medicines

www.eof.gr

Denmark

Lægemiddelstyrelsen

www.dkma.dk

Estonia

State Agency of Medicines

www.sam.ee

Ireland

Irish Medicines Board

www.imb.ie

Iceland

Lyfjastofnun

www.lyfjastofnun.is

Spain

Agencia española del medicamento

www.agemed.es

Italy

Ministero della Salute

www.ministerosalute.it

Cyprus

Ministry of Health

Ministry of Agriculture

www.pio.gov.cy

Latvia

Food and Veterinary Service

zaale.vza.gov.lv

Lithuania

State Medicines Control Agency

State Food and Veterinary Service

www.vvkt.lt

www.vet.lt

Lichtenstein

Liechtensteinische Landesverwaltung

Amt für Lebensmittelkontrolle und Veterinärwesen

Kontrollstelle für Arzneimittel

www.llv.li

Luxembourg

Ministère de la Santé

Division de la Pharmacie et des Médicaments

www.etat.lu/MS

Malta

Medicines Authority

medicinesauthority.gov.mt

Norway

Statens Legemiddelverk

www.legemiddelverket.no

Poland

Office for Medicinal Products

http://www.urpl.gov.pl

Portugal

Instituto Nacional da Farmácia e do Medicamento

www.infarmed.pt

Romania

National Medicines Agency

National Sanitary Veterinary Agency

www.anm.ro/home.html

Slovak Republic

State Institute for Drug Control

Institute for State Control of Veterinary Biologicals and Medicaments

www.sukl.sk

Slovenia

Agency of the Republic of Slovenia for Medicinal Products and Medical Devices

http://www2.gov.si/mz/mz- splet.nsf

Hungary

National Institute of Pharmacy

Institute for Veterinary Medicinal Products

www.ogyi.hu

Finland

Lääkelaitos

www.nam.fi

France (H)

Agence Française de Sécurité Sanitaire des Produits de Santé

www.afssaps.sante.fr

France (V)

Agence Française de Sécurité Sanitaire des Aliments

www.anmv.afssa.fr

Netherlands

Staatstoezicht op de volksgezondheid

Inspectie voor de Gezondheidszorg

www.igz.nl

Netherlands

College ter Beoordeling van Geneesmiddelen (CBG)

http://www.cbg-meb.nl

Czech Repbulic

State Institut for Drug Control

Institute for the State Control of Veterinary Biologicals and Medicaments

www.sukl.cz

www.uskvbl.cz

Sweden

Läkemedelsverket

www.lakemedelsverket.se

Working time of the Bulgarian Drug Agency: 09:00 - 17:30
Visiting time of BDA Records
(room №103; tel. 8903429; 8903430; 8903431):
09:00 - 17:30
Visiting time of BDA Acounting office and Pay Desk
(room №102 and 112; tel. 8903412; 8903422; 8903423)
09:00 - 17:30
BDA address: 8, Damyan Gruev Str.
1303, Sofia, Bulgaria
UIC by Bulstat: 121203554
Bank information: IBAN: BG85 UNCR 7630 3100 1128 90
BIC: UNCRBGSF
Bank: UniCredit Bulbank, Kaloyan branch

Administration and departments

HISTORY OF THE MEDICINAL REGULATION IN BULGARIA


Medicinal regulation is the contemporary internationally adopted term to denote the totality of activities carried out by the state in different spheres of the pharmaceutical sector so as to ensure society with medicines of high quality, efficiency and safety.

In compliance with the adopted terminology nowadays, established on the basis of long scientific and practical experience, a medicine is any finished product which is a substance or combination of substances intended for the treatment or prophylactics of diseases in people and is offered in a finished package, as well as a substance or combination of substances administered to people to diagnose or recover, correct or change man’s physiological functions.

This definition emphasizes the useful and more popular aspect of medicines. Yet the latter is a product which may be dangerous as well.

This was a fact known by the ancient Egyptians and Greeks, who 1000 years B.C. controlled the production of healing remedies. This was a fact known by the muddy ahibi in the Arab countries, who controlled the extracts contained in medicines at that time.

That is what the people of the 20th century recalled, when in the early 60’s, the thalidomide, taken against morning indisposition, led to the birth of more than 6 000 babies with deformities. The thalidomide tragedy made people understand that medicines are products which require an obligatory, constant and stricter control, in compliance with the development of human knowledge.

Bulgaria is a country which in its postliberation history has paid due attention to this process and today, grounded in tradition, is defending its place of a European country with an up-to-date medicinal regulation.

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