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Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Ilda Mallkuçi

National Agency for Medicines and Medical Devices,
Tirana, 1001
Albania

Publications
  • Review Article
    Regulatory Framework of Orphan Medicines in Albania
    Author(s): Ilda MallkuçiIlda Mallkuçi

    There are no legal basis for the orphan medicines mentioned in Law No. 105/2014, 31.07.2014 “On drugs and pharmaceutical service”, amended. They are regulated by this low as the other medicines authorized in Albania according to the centralized procedure. This procedure is applied for the medicines authorized from EMA and FDA. The main document for this procedure is the Certificate of the Pharmaceutical Product from EMA or FDA. Specific requirements for the centralized procedure are detailed in Decision of the Council of Ministers No. 299, 08.04.2015. Actually in Albania are authorized for marketing 14 orphan medicines; they are designed for the treatment of rare diseases as mucopolysaccharidosis II and VI, Fabry disease, Cystic Fibrosis, Acromegaly Pituitary.. Read More»
    DOI: 10.4172/2167-7689.1000190

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Google Scholar citation report
Citations: 533

Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report

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