Dear colleagues

We inform you that according to the part 18 of article 16 of the Law "On medicines" of the Republic of Armenia, the Registration Certificate will be also accompanied by the Summary of Product Characteristics and Patient Information Leaflet of the medicine in Armenian, which are the basis for the identification, quality control and (or) official information of medicines at all stages of medicine circulation in the Republic of Armenia.

Therefore, when applying for re-registration, it is necessary to present the Summary of Product Characteristics and the Patient Information Leaflet in Armenian of the medicine registered in Armenia.