National regulations in Radiopharmacy: Is the present situation generally acceptable?

Darkovska-Serafimovska, Marija and Janevik-Ivanovska, Emilija and Balkanov, Trajan (2018) National regulations in Radiopharmacy: Is the present situation generally acceptable? In: 19th European Symposium on Radiopharmacy and Radiopharmaceuticals, 05-08 Apr 2018, Groningen, Netherlands. (Submitted)

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Radiopharmaceuticals are radioactive drugs used for diagnostic and therapeutic purposes. As radiopharmaceuticals are radioactive drugs, both radiological and pharmaceutical regulations apply to the practice of radiopharmaceutical production and their clinical and research use. Production, control, distribution and clinical application of radiopharmaceuticals in EU have not been subject to the same regulations and legislation developed for conventional pharmaceutical products. These regulations are prepared by the respective national regulatory authorities. The registration process to obtain official market authorisation for a radiopharmaceutical have been introduced in most countries. This process of registration is constantly changing with regards to the amount and the type of documentation required by the health authorities. But, the general requirements for the systems applied in pharmacy for the production, control, quality assurance and medical application have become an integral part of the field of radiopharmacy. Generally, regulations of radiopharmaceuticals in Republic of Macedonia are in compliance with EU regulative, but marketing authorisation is not recognize in practise, although the regulation requires it. Which is the reason for this?

Item Type: Conference or Workshop Item (Poster)
Subjects: Medical and Health Sciences > Health sciences
Divisions: Faculty of Medical Science
Depositing User: Marija Darkovska-Serafimovska
Date Deposited: 11 Apr 2018 08:29
Last Modified: 11 Apr 2018 08:29

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