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New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation

://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2009/2009_03/41a/41a.pdf Zakon o lijekovima [Medicinal products act, in Croatian]. Narodne novine 71/2007. Zakon o izmjenama i dopunama Zakona o lijekovima [Act on Amendments to the Medicinal Products Act, in Croatian]. Narodne novine 45/2009. Pravilnik o postupku i načinu davanja odobrenja za stavljanje gotovog lijeka u promet [Ordinance on the procedure and method for granting marketing authorization for medicinal products, in Croatian]. Narodne novine 113

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Approved genetically modified (GM) horticultural plants: A 25-year perspective

-browning Arctic ® Fuji apple (16-004-01p). USDA APHIS Docket No. APHIS-2016-0043. https://www.aphis.usda.gov/brs/aphisdocs/16_00401p_fonsi.pdf . Accessed 24 September 2017. APHIS, 2016b. Response letter to the request for confirmation that transgene-free, CRISPR-edited mushroom is not a regulated article. USDA APHIS. https://www.aphis.usda.gov/biotechnology/downloads/reg_loi/15-321-01_air_response_signed.pdf . Accessed 4 April 2018. APHIS, 2017a. BRS list of varieties requiring import authorization. Updated 3 October 2017. USDA APHIS. https

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Legal Regulations System in the Implementation Process of Geothermal District Heating Investments

requirements for groundwater intervention and water well drilling [27] Government Decree No. 147/2010 on general rules for activities and installations for the recovery, protection and remediation of waters [28] Government Decree No. 157/2005 on implementation of XVIII of 2005 on District Heating Services [29] Government Decree No. 314/2005 on Environmental Impact Assessment and the integrated environmental authorization procedure [30] Government Decree No. 320/2010 of the Hungarian Trade Licensing Office and the regional metrological and technical

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Airport Planning and Design – Legal and Professional Competence Requirements

Abstract

Airport design and planning considerably differs from the design of other transport infrastructure. The reasons are the wide scope of regulation in civil aviation and the lack of links between the Civil Aviation Act and the Building Act. The effect is that the sequence of procedures, negotiation, and/or document approval is not clearly defined. The situation is further complicated by the fact that an airport is a unique construction both for the investor and for the local building authority. The paper is an outcome of our research, building on long-term experience in airport planning and design, and the elucidation of planning and approval processes with experts from the Transport Authority and the Ministry of Transport and Construction of the Slovak Republic.

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Reach - an overview

References Strategy for a Future Chemicals Policy - White Paper. COM. (2001). 88 final, 27 February 2001. Regulation (EC) No 1907/2006 Of The European Parliament And Of The Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission

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Current regulatory and market environment for biosimilars in Serbia

Abstract

Background: Biosimilars are currently a reality of the pharmaceutical market in the European Union. This paper describes the current regulatory policy for approving biosimilars both in the European Union and in Serbia, which is not a Member State. Also, a comprehensive analysis on biosimilars consumption data on the Serbian market has been performed.

Methods: The European Medicines Agency has established a series of biosimilar scientific guidelines that comprises a regulatory policy for biosimilars in the European Union. This has enabled different biosimilar products to be marketed, making the European Union biosimilar market the most developed one globally. In the paper, this regulatory environment has been analysed, emphasising all relevant biosimilar guidelines as well as marketed biosimilar medicines. Also, an analysis is performed on Serbian regulatory requirements for approving and marketing biosimilars, analysing the Serbian regulatory authority’s consumption data as well as data available from the National Health Insurance Institution.

Results: In the paper, the comprehensive analysis of the current European Union as well as Serbian regulatory environment has been presented, with a special emphasis on the Serbian market potential for biosimilar medicines. Detailed consumption data has been analysed for the period 2007-2011.

Conclusion: Serbia has good potential for biosimilar products, which is supported by national health insurance policy and the general trend of cutting the reimbursement costs for prescription medicines. Five year consumption data for biosimilars in Serbia shows that the Serbian biosimilars market is very small in terms of market share values, especially comparing to other large European biosimilar markets.

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Approaches for Management of Chemical Substances: Challenges and Solutions

concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC). Extended Impact Assessment. European Commission. Brussels. http://ec.europa.eu/environment/chemicals/reach/background/docs/eia-sec-2003_1171.pdf Anonymous (2005a). Marketing restrictions website. European Commission. Brussels. http://europa.eu.int/comm/enterprise/chemicals/legislation/markrestr/ Anonymous (2006). Regulation (EC

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Extending OpenID Connect Towards Mission Critical Applications

Object Computing, 2011, pp. 129-138. 20. Hardt, Dick. The OAuth 2.0 Authorization Framework. 2012. 21. Alecu, F., P. Pocatilu, G. Stoica et al. OpenID, a Single Sign-on Solution for e-Learning Applications. – Journal of Mobile, Embedded and Distributed Systems, Vol. 3 , 2011, No 3, pp. 136-141. 22. Sun, S.-T., K. Hawkey, K. Beznosov. Systematically Breaking and Fixing Openid Security: Formal Analysis, Semi-Automated Empirical Evaluation, and Practical Countermeasures. – Journal Computers and Security, Vol. 31 , 2012, No 4, pp. 465-483. 23

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Look before you Authorize: Using Eye-Tracking to Enforce User Attention towards Application Permissions

Abstract

Habituation is a key factor behind the lack of attention towards permission authorization dialogs during third party application installation. Various solutions have been proposed to combat the problem of achieving attention switch towards permissions. However, users continue to ignore these dialogs, and authorize dangerous permissions, which leads to security and privacy breaches.

We leverage eye-tracking to approach this problem, and propose a mechanism for enforcing user attention towards application permissions before users are able to authorize them. We deactivate the dialog’s decision buttons initially, and use feedback from the eye-tracker to ensure that the user has looked at the permissions. After determining user attention, the buttons are activated. We implemented a prototype of our approach as a Chrome browser extension, and conducted a user study on Facebook’s application authorization dialogs. Using participants’ permission identification, eye-gaze fixations, and authorization decisions, we evaluate participants’ attention towards permissions. The participants who used our approach on authorization dialogs were able to identify the permissions better, compared to the rest of the participants, even after the habituation period. Their average number of eye-gaze fixations on the permission text was significantly higher than the other group participants. However, examining the rate in which participants denied a dangerous and unnecessary permission, the hypothesized increase from the control group to the treatment group was not statistically significant.

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The right to dispose of an item of property acquired in marriage

Abstract

This research article analyzes the right of disposal of marital property in relation to the undertaking of those legal actions that imply the highest authorizations that legal subjects can have over things.

Having in consideration the fact that according to the legislation in the Republic of Macedonia, marital property is joint as are the authorizations of spouses over their joint items, it is important to determine the extent of the disposal, i.e. who disposes of the items of the joint property and to what extent. Referring to the normative framework, which regulates disposal relations of spouses, the article emphasizes the concept and importance of the authorization of disposal of things (alienation or assignment of things from joint ownership), through legal activities (sale, donation, exchange, etc.). In this context, the article tends to draw a divisive line between the administration with the joint item, referring to continuative actions and measures and the disposal of the thing, which is not continuative but, due to legal consequences it causes, has great importance in practice, and as a result, enjoys greater attention in legislators in terms of its limitation compared to the acts of administration with joint items in marriage.

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