Pharmaceutical Regulatory Affairs: Open Access

Ilda Mallkuçi

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

  Abstract PDF