scholarly journals Legislation On The Preparation Of Medicinal Products In European Pharmacies And The Council Of Europe Resolution

2020 ◽  
Vol 6 (1) ◽  
pp. 67
Author(s):  
H PA Scheepers ◽  
J Langedijk ◽  
V Neerup Handlos ◽  
S Walser ◽  
M H Schutjens ◽  
...  
2017 ◽  
Vol 24 (4) ◽  
pp. 414-431
Author(s):  
Katherine Wade*

Abstract It is important that clinical research with children is encouraged so that they are not exposed to the dangers of extrapolation from adult treatments. Clinical trials with investigational medicinal products (imps) are an important part of improving medical care for children. Both the 2001 Clinical Trials Directive and the 2014 Regulation recognise the need for such research, including the need for non-therapeutic trials with imps. However, it is also recognised that a balance must be struck between permitting tailored medical care for children as a group on the one hand, and protecting individual trial participants from harm on the other. A central issue in striking this balance relates to defining the threshold of risk which should be permitted in such research. This article provides a critical analysis of the current European law in relation to the definition of acceptable risk for non-therapeutic clinical trials with imps and makes recommendations for reform, drawing on law from the Council of Europe, as well as law from the us.


2020 ◽  
Vol 51 (1) ◽  
pp. 1-4
Author(s):  
Svjetlana Terzić ◽  
Miroslav Andrišić ◽  
Eleonora Perak Junaković ◽  
Dominika Fajdić ◽  
Mirta Pehnec ◽  
...  

Dana 1. siječnja 2020. godine u Republici Hrvatskoj na snagu je stupila Konvencija Vijeća Europe o krivotvorenju farmaceutskih proizvoda i sličnim kažnjivim djelima koja uključuju prijetnje javnom zdravlju (engl. Council of Europe Convention on counterfeiting of medicinal products and similar crimes involving threats to public health). Konvencija je potpisana 3. rujna 2015. godine, a Vlada Republike Hrvatske ju je ratificirala 20. rujna 2019. godine. Konvencija se odnosi i na medicinske proizvode koji se koriste u veterinarskoj medicini. Važnost borbe protiv krivotvorenih lijekova prepoznata je u Hrvatskoj godinama, a Hrvatska je i jedna od brojnih sudionica Interpolovih akcija protiv krivotvorenih lijekova. Prihvaćanjem ove Konvencije otvara se mogućnost učinkovitijeg nadzora nad krivotvorenim lijekovima za primjenu u humanoj i veterinarskoj medicini te bolja međunarodna suradnja.


2016 ◽  
Vol 24 (4) ◽  
pp. 224-229 ◽  
Author(s):  
H PA Scheepers ◽  
J Langedijk ◽  
V Neerup Handlos ◽  
S Walser ◽  
M H Schutjens ◽  
...  

2006 ◽  
Vol 13 (3) ◽  
pp. 235-261 ◽  
Author(s):  
Salla Lötjönen

AbstractCurrent international legal instruments recognise the use of advance directives to carry on the will of the dementing research participant beyond the boundaries of her present legal capacity. Advance directives are gaining greater recognition in patient care than in medical research, where their legal status is still somewhat unclear. In particular, the three major international documents on medical research – the Council of Europe Convention on Biomedicine and Human Rights (ETS 164), its Additional Protocol on Biomedical Research (ETS 195), and Directive 2001/20/EC on Clinical Trials on Medicinal Products – give conflicting messages on the legal status of advance directives in medical research. This article examines the provisions in these documents and their national applications in Finland and the United Kingdom.


2020 ◽  
Vol 73 (12) ◽  
pp. 2733-2736
Author(s):  
Pavlo S. Berzin ◽  
Ivan S. Demchenko ◽  
Anzhela B. Berzina

The aim: Medicrime Convention is a first international treaty against counterfeit medical products and similar crimes involving threats to public health. There are problems in criminalization of those acts that are listed in Art. 8 of the Medicrime Convention because the term of “similar crimes” is absent in the current criminal legislation of Ukraine. Materials and methods: The conducted study is based on the analysis of the provisions of the Medicrime Convention, the criminal legislation of Ukraine. The following methods: dialectical method; hermeneutic method; system-and-structural method; comparative-and-law method were used. Results: Comparison of the provisions of the Medicrime Convention allows to state that crimes in its Articles 5-8 that are different from those provided for in Art. 5-7 of this Convention and form independent types of actions, are at least “placing on the market” of medicinal products and medical devices provided in subparagraph “a” of paragraph 1 of Art. 8 and “commercial use of original documents” specified in subparagraph “b” of paragraph 1 of Art. 8. It's an assumption that Art. 5-8 of the Medicrime Convention provide for such independent types of crimes involving threats to public health as: 1) manufacturing of counterfeit medical products, active substances, excipients, parts, materials and accessories as well as medicinal products, medical devices, active substances and excipients; 2) the supplying, the offering to supply, the brokering, the trafficking, the keeping in stock, importing and exporting of counterfeit medical products, active substances, excipients, parts, materials and accessories; 3) the making of false documents or the act of tampering with documents; 4) placing on the market of medicinal products, medical devices; 5) the commercial use of false documents. Conclusions: The term of “similar crimes” in Art. 8 of the Medicrime Convention covers multi-ordinal intentional acts that constitute different types of independent crimes involving threats to public health, as well as special kinds of some of them. These types of crimes are not the same (identical).


Sign in / Sign up

Export Citation Format

Share Document