The President of Azerbaijan, Ilham Aliyev, has approved amendments to the Administrative Offenses Code. Media reports have spread information that pharmacies will be fined for selling medicines without an instruction for use. To prevent confusion among the population, we would like to inform that one of the most important measures taken to prevent a shortage of medicines in the country is the simplification of the registration and expertise procedures for medicines and the recognition of international registration.
If the instruction for use (leaflet) of a medicinal product is in any foreign language, the certificate holder must provide the pharmacy with a leaflet approved in the Azerbaijani language. This requirement is reflected in Article 11.3 of the Law of the Republic of Azerbaijan on Medicinal Products. If the medicinal product is not accompanied by a leaflet in Azerbaijani, the pharmacy is required to provide the consumer with a printed copy of the instruction upon request. The certificate holder of the medicinal product is obliged to ensure the pharmacy has the instruction in Azerbaijani.
If this legislative requirement is violated, a protocol will be drawn up under Articles 221.13 and 221.14 of the Administrative Offenses Code, and administrative sanctions will be applied. According to Article 221.3, if the medicinal product is not accompanied by an instruction in Azerbaijani, and the pharmacy is not provided with the Azerbaijani instruction, the certificate holders will be fined: 1500-2000 manats if the responsible person is an individual, and 5000-7000 manats if the responsible party is a legal entity.
Pharmacies will be fined 50 manats for failing to provide the consumer with a printed copy of the leaflet, if the pharmacy is supplied with an Azerbaijani-language instruction approved by the certificate holder.
Additionally, it should be noted that one of the changes in the healthcare sector, based on the President’s instructions, is the electronic prescription system, through which citizens can also view the instructions for medicines electronically. For this, citizens can enter the “Medicines” section of the electronic prescription system and obtain the corresponding instruction.
We would also like to remind citizens that if they encounter any problems in private medical institutions or pharmacies, they can contact us through AEC’s “one-stop” system, the “hotline” (012 596 05 20), the email address [email protected], or the “Write us” section on the pharma.az website. In this case, an investigation will be carried out, and if necessary, a decision will be made regarding an unscheduled inspection.
