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Procesna vprašanja pridobitve dovoljenja za promet z zdravili
Lobe, Tea (Author), Pirnat, Rajko (Mentor) More about this mentor... This link opens in a new window

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Abstract
Trgovanje z zdravili sodi med najbolj regulirano področje v industrijskem sektorju. Temeljno načelo v okviru celotne Evropske unije in Evropskega gospodarskega prostora je, da je lahko zdravilo na trgu le na podlagi dovoljenja za promet. Postopek pridobitve dovoljenja za promet je upravni postopek, kateri se bo uporabil pa je odvisno od tega, kje se bo zdravilo tržilo. Poznamo nacionalni postopek, postopek z medsebojnim priznavanjem, decentraliziran postopek in centraliziran postopek. Cilj, ki ga zakonodaja na področju zdravil zasleduje, je varovanje javnega zdravja. Postopke pridobitve dovoljenja za promet vodijo regulatorni organi. Na ravni Evropske unije je ta organ Evropska agencija za zdravila (skrajšano EMA), v Slovenija pa Javna agencija za zdravila in medicinske pripomočke (skrajšano JAZMP). V farmacevtskem sektorju ločimo dve vrsti podjetij. Podjetja, ki proizvajajo inovativna zdravila in so dejavna predvsem na področju raziskav za nova zdravila ter podjetja, ki proizvajajo generična zdravila, ki so enakovredna inovativnim, vendar precej cenejša. Glede na to, ali se pridobiva dovoljenje za promet z inovativnim zdravilom ali generičnim zdravilom, je prilagojen tudi postopek pridobitve dovoljenja za promet. Pri tem imajo proizvajalci inovativnih zdravil pogosto interes sodelovanja v postopku ali uveljavljanje pravnih sredstev zoper izdano odločbo za generično zdravilo. Ker evropska zakonodaja teh možnosti izrecno nikjer ne navaja, je to področje že večkrat bilo predmet sodnih odločitev, ki pravne praznine na tem področju zapolnjujejo.

Language:Slovenian
Keywords:farmacevtski sektor, dovoljenje za promet z zdravili, inovativna zdravila, generična zdravila, javno zdravje, regulatorni organi, referenčna država, zadevna država, JAZMP, EMA
Work type:Master's thesis/paper (mb22)
Organization:PF - Faculty of Law
Year:2019
COBISS.SI-ID:16644945 This link opens in a new window
Views:548
Downloads:225
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Secondary language

Language:English
Title:Procedural questions of obtaining marketing authorization for medicinal products
Abstract:
Trade in medicinal products is one of the most regulated areas in the industrial sector. The fundamental principle throughout the European Union and the European Economic Area is that a medicinal product on the market can only be present based on a marketing authorization. The procedure for getting a marketing authorization is an administrative procedure and which one will be used depends on where the product will be marketed. We know a national procedure, a mutual recognition procedure, a decentralized procedure and a centralized procedure. The objective pursued by the legislation on the field of medicinal products is the protection of public health. The procedures for getting a marketing authorization are managed by the regulatory authorities. At European Union level, the authority is the European Medicines Agency (EMEA), while in Slovenia it is the Agency for Medicinal Products and Medical Devices (JAZMP). There are two types of companies in pharmaceutical sector - companies that produce innovative medicinal products and are mainly active in research for new medicinal products and companies that produce generic medicinal products that are equivalent to innovative but much cheaper because they do not need to carry out expensive researches. Depending on whether they are getting a marketing authorization for an innovative medicinal product or a generic one, the procedure is also adjusted. Innovative medicinal products manufacturers often have an interest in cooperating in the procedure or enforcing the legal assets against the issued order for generic medicinal product. Since European legislation does not explicitly state these options, this area has been repeatedly a subject to judicial decisions that fill legal vacuum in this area.

Keywords:Pharmaceutical sector, marketing authorization for medicinal products, innovative medicines, generic medicines, public health, regulatory bodies, reference Member State, concerned Member State, JAZMP, EMEA

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