A comparison of the Albanian pharmaceutical legislation with the European pharmaceutical directives and the Italian pharmaceutical legislation

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Studi, ricerche
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pp. 324,      1a edizione  2021   (Codice editore 1820.331)

A comparison of the Albanian pharmaceutical legislation with the European pharmaceutical directives and the Italian pharmaceutical legislation
Tipologia: Edizione a stampa
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Codice ISBN: 9788835117070
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Codice ISBN: 9788835122326
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In breve

This book is a novelty in the form and content and the first of its kind in the field of the Albanian Pharmaceutical Legislation. It brings a contribution to the policy makers in adapting the current Albanian pharmaceutical law by confronting it with the European pharmaceutical directive 2001/83/CE, and further modifications, and the respective Italian legislation. The authors provide a missing work in the field of harmonization of the Albanian pharmaceutical legislation with the best practices in European Union countries.

Presentazione del volume

This book is a novelty in the form and content and the first of its kind in the field of the Albanian Pharmaceutical Legislation. Over the years, there have been several changes to the Albanian law "For medicinal products and pharmaceutical service".
Albania is not yet a European Union member, and this book brings a contribution to the policy makers in adapting the current Albanian pharmaceutical law by confronting it with the European pharmaceutical directive 2001/83/ CE, and further modifications, and the respective Italian legislation. The authors provide a missing work in the field of harmonization of the Albanian pharmaceutical legislation with the best practices in European Union countries.
Step by step, the reader will be provided with different pharmaceutical aspects, such as drug placement in the market, manufacture and importation, labelling and package leaflet, classification of medicinal products, wholesale distribution and brokering of medicinal products, advertising, sanctions etc.
This contribution will increase the awareness of health professionals, academia, institutions, governments and policymakers, and will encourage the implementation of European Union directives on Albanian pharmaceutical legislation. It will be also of help to the pharmaceutical sector and foreign pharmaceutical companies interested to understand better the legislation in Albania and the difference with the EU directives.

Prof. Paola Minghetti graduated in Pharmacy and Industrial Pharmacy cum laude, obtained her PhD in Pharmaceutical Sciences. She is full professor of Pharmaceutical Technology and Regulatory Affairs at Università degli Studi di Milano. She is an expert of the Italian Pharmacopoeia and member of a team appointed by EDQM for the creation of the monograph "Pharmaceutical Dosage Forms". She is member of the AIFA Evaluation and Authorization Secretariat. Her research is mainly related to: transdermal and buccal drug delivery systems; doctrinal elaboration of national and UE legislation related to the production and the commercialization of medicinal products, medical devices, and health products; and magistral formula compounding in hospital and community pharmacies.

Assoc. Prof. Linda Pustina has been graduated with excellent results in Pharmacy and in Biological Sciences at the University of Milan, Italy, and later concluded the studies in Medicine and the studies on Law at the University of Tirana. She concluded doctoral studies at the Faculty of Pharmacy, University of Milan, Italy, in Pharmacotoxicological, Pharmacognostic and Pharmacologic Biotechnology Sciences receiving the Doctor of Science degree with maximum evaluation and has received the title of Associated Professor from the University of Tirana. During this period, she has been awarded several scholarships for research at the University of Milan and she published several scientific papers in international journals.

Dr. Malvina Hoxha has been graduated in Pharmacy (Summa Cum Laude), and she obtained her PhD in Pharmacological Sciences at the University of Milan, Italy. Dr. Hoxha is the author and co-author of numerous articles and publications in international journals and scientific conferences, as well as a winner of various awards.

Indice

Definitions
Scope
Placing on the market
Manufacture and Importation
Labelling and package leaflet
Classification of medicinal products
Wholesale distribution and brokering of medicinal products
Advertising
Information and advertising
Special provisions on medicinal products derived from human blood and plasma
Supervision and sanctions
Standing Committee
General Provisions
Final Provisions.