Suchergebnisse

The legal regulation of pharmacovigilance is overviewed in this master thesis. In the first part the concept, sorts and history of pharmacovigilance are analysed. In the second part the current European Union legislation on pharmacovigilance is analysed, comparing it to legislation that will come into force in july, 2012, pointing to the main changes and its meaning to the European Union system of pharmacovigilance. In the third part Lithuanian legislation on pharmacovigilance is analysed and the efficiency of national system of pharmacovigilance is assessed.

The legal regulation of pharmacovigilance is overviewed in this master thesis. In the first part the concept, sorts and history of pharmacovigilance are analysed. In the second part the current European Union legislation on pharmacovigilance is analysed, comparing it to legislation that will come into force in july, 2012, pointing to the main changes and its meaning to the European Union system of pharmacovigilance. In the third part Lithuanian legislation on pharmacovigilance is analysed and the efficiency of national system of pharmacovigilance is assessed.

Gausybėje Lietuvos teisės normų grupių galima įžvelgti savitą asmens duomenų apsaugos teisinį reguliavimą. Jame apstu sąsajų su administracine ir civiline teise, o jo turinys nulemtas konstitucinės asmens privataus gyvenimo neliečiamumo garantijos. Lietuvos teisės literatūroje asmens duomenų apsaugos teisės (ją sudarančių normų ir principų komplekso) savitumas ir išskirtinumas beveik netirtas. Šią nišą svarbu užpildyti, o tai galima padaryti nagrinėjant su asmens duomenų tvarkymu susijusių visuomeninių santykių teisinio reguliavimo raidą Lietuvoje ir šio teisinio reguliavimo specifiką tradicinio teisės sistemos skirstymo į sudėtinius elementus (teisės šakas, pošakius, institutus) požiūriu.A distinctive data protection legislation can be seen in abundance of groups of Lithuanian rules of law. There are many relations with administrative and civil law in it, and its content is determined by constitutional right to respect for private life. Distinction and oneness of data protection law (a complex of rules and principles of which the law consists) was hardly explored in Lithuanian legal literature. This niche is important to fill in, and it is possible to do this when exploring the development of legal regulation on personal data processing in Lithuania and the particularity of this legal regulation in view of traditional division of legal system into integrate elements (branches of law, subbranches, and institutes).

In this work regulation and implementation of electronic signature is analysed from 2000 to 2005. The information in this work is based on statistics data of Information Society Development Committee and Statistics department under Government of Lithuania Republic, laws issued by Seimas of Lithuania Republic and decisions made by Government of Lithuania Republic. It is affirmed, that qualified electronic signature has the same legal force to electronic data as signature on written documents. Qualified electronic signature will be introduced and implemented in public institutions providing electronic services to legal and physical entities by "one window" principle.

In this work regulation and implementation of electronic signature is analysed from 2000 to 2005. The information in this work is based on statistics data of Information Society Development Committee and Statistics department under Government of Lithuania Republic, laws issued by Seimas of Lithuania Republic and decisions made by Government of Lithuania Republic. It is affirmed, that qualified electronic signature has the same legal force to electronic data as signature on written documents. Qualified electronic signature will be introduced and implemented in public institutions providing electronic services to legal and physical entities by "one window" principle.

In this work regulation and implementation of electronic signature is analysed from 2000 to 2005. The information in this work is based on statistics data of Information Society Development Committee and Statistics department under Government of Lithuania Republic, laws issued by Seimas of Lithuania Republic and decisions made by Government of Lithuania Republic. It is affirmed, that qualified electronic signature has the same legal force to electronic data as signature on written documents. Qualified electronic signature will be introduced and implemented in public institutions providing electronic services to legal and physical entities by "one window" principle.

In this work regulation and implementation of electronic signature is analysed from 2000 to 2005. The information in this work is based on statistics data of Information Society Development Committee and Statistics department under Government of Lithuania Republic, laws issued by Seimas of Lithuania Republic and decisions made by Government of Lithuania Republic. It is affirmed, that qualified electronic signature has the same legal force to electronic data as signature on written documents. Qualified electronic signature will be introduced and implemented in public institutions providing electronic services to legal and physical entities by "one window" principle.

The article analyses the legal regulation of electronic marketing in the European context. The historical and teleological perspective on past and present regulations of electronic marketing is provided. Emphasis is given on the ability of the legal rules to preserve the balance of private and entrepreneurial interests, and the desirable principles of the regulation of the socially beneficial electronic marketing. The paper concludes that the harmonization of legal regulation of electronic marketing at the European Union level is limited, which causes numerous negative consequences, such as jurisdiction shopping. Some countries (e.g. Finland) follow opt-out regimes for at least some types of electronic marketing, while other countries (including Lithuania) prohibit most forms of electronic marketing without the prior consent of the customer (opt-in). Thus, further regulation and harmonization of the electronic marketing law is suggested at the regional (the EU) and national level, along with more self-regulation and a balanced approach towards future regulation. ; Straipsnyje nagrinėjamas elektroninės rinkodaros teisinis reguliavimas Europos valstybėse ir Lietuvoje. Analizuojami elektroninės rinkodaros socialiniai-ekonominiai pranašumai ir neigiami aspektai, lyginant su tradicinės rinkodaros priemonėmis. Pateikiama elektroninės rinkodaros vadybinė ir teisinė samprata, identifikuojamos pagrindinės formos ir jų ypatumai. Teisinio reguliavimo analizė pateikiama istorinėje ir teleologinėje perspektyvoje, akcentuojamas europiniame teisiniame reguliavime nuo 1985 m. pripažintas poreikis balansuoti asmens privatumo ir ekonominius verslo interesus. Europinės teisės ir jurisprudencijos analizė fokusuojama į Europos Sąjungos direktyvų ir ankstesnių teisės aktų analizę, taip pat teisinio harmonizavimo vertinimą. Analizėje ypač skiriamas dėmesys tiems aspektams, kurių ES teisė nereguliuoja, o nacionalinės teisės sistemos reguliuoja įvairiai. Pastebima, kad elektroninės rinkodaros teisinis reguliavimas gana ribotai harmonizuotas europiniu lygiu. Daug svarbių principų ir taisyklių paliekama reguliuoti nacionalinei teisei, todėl įvairiose ES valstybės narėse reguliavimas gerokai skiriasi, o tai sukuria teisines kolizijas ir vertinama negatyviai. Šiuo metu elektroninės rinkodaros teisiniame reguliavime iš esmės dominuoja privatumo pažeidimų ir neteisėtos elektroninės rinkodaros draudimo klausimai. Šie klausimai, ypač Lietuvos teisėje ir teismų praktikoje, užgožia teigiamus elektroninės rinkodaros aspektus, kurie Lietuvoje priešingai nei ES dokumentuose, net nėra įstatymiškai pripažinti. Taip pat pasakytina, kad didelė dalis elektroninės rinkodaros apskritai nėra reguliuojama, nepaisant to, kad jos keliami privatumo iššūkiai yra dar didesni. Straipsnyje nagrinėjama užsienio jurisprundencija ir kai kurių ES valstybių patirtis ieškant geriausios elektroninės rinkodaros reguliavimo praktikos. Identifikuojami teisinio reguliavimo principai, kuriais turėtų būti grindžiama elektroninės rinkodaros teisinio reguliavimo plėtra. Rekomenduojamas išsamesnis visų elektroninės rinkodaros formų teisinis reguliavimas ir jo harmonizavimas europiniu lygiu, būtinybė griežtinti sankcijas ir plėsti atsakomybės subjektų ratą už neteisėtą elektroninę rinkodarą, taip pat toliau plėtojant savireguliacijos plėtrą elektroninės rinkodaros srityje.

This article deals with the questions related to legal regulation of new information technologies (further - IT) in the modern society. Nowadays technical and technological priorities prevail in the Lithuania and questions of the protection of human rights and protection of juveniles from the dangerous influence are neglected. The author of the article analyzes three main directions of the regulation of new IT: protection of the juveniles from the dangerous influence in the new information situation; problems of protection of privacy and questions of protection of intellectual property. Experience of foreign countries is presented and the gaps of legal regulation of the Republic of Lithuania are analyzed. The author suggests to treat the information presented through the new IT as public information and legalize Internet as a tool media. The article bases on the need to improve legal basis in the line of protection juveniles from the influence of dangerous information. For the protection of the development of new IT's from the influence of legal regulation antitrust laws need to be forbidden and means of protection of authors' rights should be compatible with development of new IT, i. e., legal responsibility for violations of authors' rights should be balanced between illegal distributors of computer programs and their users. ; Naujųjų informacinių technologijų plėtra verčia spręsti jų teisinio reguliavimo klausimą. Įstatymai gali skatinti arba lėtinti technikos naujovių plėtros procesus. Šiuo metu Lietuvoje kai kurios teisės normos neprisideda prie spartesnės naujų informacinių technologijų plėtros. Plėtojantis naujosioms visuomenės informavimo rūšims, tokioms kaip internetas, skaitmeninis radijas ir televizija, stiprėja visuomeninio transliuotojo vaidmuo. Vis dažniau susiduriame su visuomenei žalingos informacijos platinimo, privatumo ir intelektinės nuosavybės apsaugos problemomis. Svarbu, kad kuriantis naujoms informacinėms technologijoms sparčiai tobulėtų ir įstatymai, reguliuojantys šioje srityje atsirandančius visuomeninius santykius. Technikos progresas negali ir neturi griauti teisės, kaip vienintelės tūkstantmečiais puoselėtos demokratinės visuomenės vertybės, reguliuojančios teisės subjektų santykius. Vykstant technologinei revoliucijai demokratinėje valstybėje neturi likti sričių, kurios teisei būtų neprieinamos. Kadangi internetas ir kita naujoji komunikacija nepripažįsta geografinių sienų, kyla būtinybė tarptautinių susitarimų ir sutarčių pagrindu reguliuoti kai kuriuos iki šiol nežinomus teisinius klausimus.

Nanotechnology regulation in the EU and the U.S. has common features in disclosure requirements and recognizing the need for risk assessment; however, significant differences emerge when it comes to informing the consumers and the public (labelling requirements). The article is ended with a summary on prospects and suggested principles for advancing nanotechnology regulation. International regulation is identified as the preferred approach, while liberal national regulation may be a beneficial initial approach in countries like Lithuania. Non-governmental and self-regulatory initiatives may be a valuable aid to the governmental regulation, since they are more adapted to changes, as it is demonstrated by the experience in regulating other emerging technologies.

Nanotechnology regulation in the EU and the U.S. has common features in disclosure requirements and recognizing the need for risk assessment; however, significant differences emerge when it comes to informing the consumers and the public (labelling requirements). The article is ended with a summary on prospects and suggested principles for advancing nanotechnology regulation. International regulation is identified as the preferred approach, while liberal national regulation may be a beneficial initial approach in countries like Lithuania. Non-governmental and self-regulatory initiatives may be a valuable aid to the governmental regulation, since they are more adapted to changes, as it is demonstrated by the experience in regulating other emerging technologies.

Integration of the European Union (EU) does not cover unification of direct taxation through the Member States. Therefore, each Member State runs its own taxation model. Nevertheless, due to the fiscal obstacles being construed in the light of Common Market the Member States are to take account of directives and other legal acts. Concerning specific institutional organization of the European Community as international body one should perceive, that Community legislation may affect national systems in three ways: by unification, harmonization and coordination. The second one is chosen for attainment of the consistency of direct taxation in the EU (coordination shouldn't be excluded either). The proximate and basic aim for this way of implementation is to be regarded as avoidance of double taxation in the international scene, though, it is not always so in the working practice of Community institutions (where it seems to be greater objectives leading to unification). After long-drawn discussions some significant results in the field of the harmonization of direct taxation were finally achieved, namely these: the Member States were obliged to retain from withholding taxes on distributed profits and on payments of interests and royalties under certain conditions; also transactions of mergers, divisions, transfers of assets and exchanges of shares concerning companies of different Member States were relieved from any taxes; Member States were required to make interests payers in their territory provide information to the tax authorities, to be exchanged automatically with the tax authorities of the States of residence of the individuals entitled to the interests payments. This system enables to arrive at the effective taxation of EU-sourced savings interests in the home State of the individual recipient only. Another achievement is to be mentioned the coordination of mutual agreement and arbitration procedure of the elimination of double taxation in connection with the adjustment of profits of associated enterprises. Historical analysis of harmonization process leads to the conclusion, that regarding main steps in the sphere of EU-direct taxation to have been done, instruments of soft law (Commission's recommendations and others) and jurisprudence of the Eurepean Court of Justice are futher means of regulation of harmonization, wich also can lead to obligatory positive rules.

Integration of the European Union (EU) does not cover unification of direct taxation through the Member States. Therefore, each Member State runs its own taxation model. Nevertheless, due to the fiscal obstacles being construed in the light of Common Market the Member States are to take account of directives and other legal acts. Concerning specific institutional organization of the European Community as international body one should perceive, that Community legislation may affect national systems in three ways: by unification, harmonization and coordination. The second one is chosen for attainment of the consistency of direct taxation in the EU (coordination shouldn't be excluded either). The proximate and basic aim for this way of implementation is to be regarded as avoidance of double taxation in the international scene, though, it is not always so in the working practice of Community institutions (where it seems to be greater objectives leading to unification). After long-drawn discussions some significant results in the field of the harmonization of direct taxation were finally achieved, namely these: the Member States were obliged to retain from withholding taxes on distributed profits and on payments of interests and royalties under certain conditions; also transactions of mergers, divisions, transfers of assets and exchanges of shares concerning companies of different Member States were relieved from any taxes; Member States were required to make interests payers in their territory provide information to the tax authorities, to be exchanged automatically with the tax authorities of the States of residence of the individuals entitled to the interests payments. This system enables to arrive at the effective taxation of EU-sourced savings interests in the home State of the individual recipient only. Another achievement is to be mentioned the coordination of mutual agreement and arbitration procedure of the elimination of double taxation in connection with the adjustment of profits of associated enterprises. Historical analysis of harmonization process leads to the conclusion, that regarding main steps in the sphere of EU-direct taxation to have been done, instruments of soft law (Commission's recommendations and others) and jurisprudence of the Eurepean Court of Justice are futher means of regulation of harmonization, wich also can lead to obligatory positive rules.