With the entry into force of the EAEU legislation on the registration of medicines, a whole range of new terms appeared, the understanding of which is key in determining the circulation strategy of the drug in the EAEU member states. One such term is “expansion of geography”. Expansion of geography — registration of the drug in the EAEU member states,
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At the end of March 2022, Decision No. 36 of the EEC Council came into force, which introduced some adjustments to the existing drug registration system (Decision No. 78). For example, the following “types” of marketing authorization became possible: registration of drugs with post-registration obligations, registration of drugs in exceptional cases, conditional registration of drugs, accelerated registration of drugs. In
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Until recently, there was no legal basis for regulating the circulation of medical devices in Armenia. The sale and import of medical equipment and products for medical use, according to the local legislation of the Republic of Armenia, did not require state registration. However, accession to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within
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Normative document for the pharmaceuticals. According to the definition of Decision No. 78 “On the Rules for Registration and Examination of Medicines for Medical Use” ‘normative document’means a document establishing requirements for the quality control of a medicinal product (it contains a specification and a description of analytical procedures and tests or references thereon, as well as appropriate acceptance criteria
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