Bulgarian Ministry Ordinance On Medicines
A recently-issued Bulgarian Ministry of Health Ordinance No 5 concerns the registration of medicines in the country. The Ordinance lays down exacting and comprehensive requirements and conditions for registration, according to the Bulgarian Economic Review.
Under Article 14 (12) 1-13 of Section Two, all medicines that will be entered in the Ministry's register of approved drugs will need to carry details of their shelf life, pharmacological group, regulations for prescription, details of side effects, generic name, details of ingredients, packing and other information.
Under Article 16 (1), any medicine will be registered for a period of five years, while under Article 16 (2), any medicine not marketed in Bulgaria for two years after its registration will be removed from the register.
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