demirba (14 risultati)

Condizione: New. 2024. 1st Edition. hardcover. . . . . .

Taschenbuch. Condizione: Neu. Neuware - A prophecy.

Taschenbuch. Condizione: Neu. Neuware -Master's Thesis from the year 2007 in the subject Law - European and International Law, Intellectual Properties, Marmara University (EUROPEAN UNION INSTITUTE), course: DEPARTMENT OF EUROPEAN UNION LAW, language: English, abstract: Data exclusivity in pharmaceuticals is one of the best protection systems among other type of regulatory drug product exclusivities such as patent protection, patent term extension and some other type of marketing exclusivities.Data exclusivity provides the right holder protection on his undisclosed information, in particular the results of tests in humans and animals and clinical trials which are given to the national authorities in order to obtain marketing approval for the drug product for which the application is made. In this regard data exclusivity means that, the second applicant can not use or rely on that data during the exclusive time period in order to obtain marketing approval for the same drug product which was already granted marketing approval first time. Like the second applicant, national regulatory authorities also can not rely on that data in order to grant marketing approval to the second applicant for the same drug product during that exclusive time period. By this reason data exclusivity differs from other type of drug product marketing exclusivities since marketing exclusivity in pharmaceutical drug products may last after data exclusivity time period expires like in the EU system. In the EU normally, while there is 8 year data exclusivity, marketing exclusivity is 10 year. Also data exclusivity differs from patent protection. In part one; firstly the focus is on the regulatory drug product exclusivities and then data exclusivity generally. In part two; data exclusivity is analyzed extensively in international law, in the EU law, in the U.S. law and lastly in Turkish law.BoD - Books on Demand, In de Tarpen 42, 22848 Norderstedt 84 pp. Englisch.

Condizione: New. 2024. 1st Edition. hardcover. . . . . . Books ship from the US and Ireland.

Taschenbuch. Condizione: Neu. Druck auf Anfrage Neuware - Printed after ordering - Master's Thesis from the year 2007 in the subject Law - European and International Law, Intellectual Properties, Marmara University (EUROPEAN UNION INSTITUTE), course: DEPARTMENT OF EUROPEAN UNION LAW, language: English, abstract: Data exclusivity in pharmaceuticals is one of the best protection systems among other type of regulatory drug product exclusivities such as patent protection, patent term extension and some other type of marketing exclusivities.Data exclusivity provides the right holder protection on his undisclosed information, in particular the results of tests in humans and animals and clinical trials which are given to the national authorities in order to obtain marketing approval for the drug product for which the application is made. In this regard data exclusivity means that, the second applicant can not use or rely on that data during the exclusive time period in order to obtain marketing approval for the same drug product which was already granted marketing approval first time. Like the second applicant, national regulatory authorities also can not rely on that data in order to grant marketing approval to the second applicant for the same drug product during that exclusive time period. By this reason data exclusivity differs from other type of drug product marketing exclusivities since marketing exclusivity in pharmaceutical drug products may last after data exclusivity time period expires like in the EU system. In the EU normally, while there is 8 year data exclusivity, marketing exclusivity is 10 year. Also data exclusivity differs from patent protection. In part one; firstly the focus is on the regulatory drug product exclusivities and then data exclusivity generally. In part two; data exclusivity is analyzed extensively in international law, in the EU law, in the U.S. law and lastly in Turkish law.

Condizione: NEW.

Taschenbuch. Condizione: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Master's Thesis from the year 2007 in the subject Law - European and International Law, Intellectual Properties, Marmara University (EUROPEAN UNION INSTITUTE), course: DEPARTMENT OF EUROPEAN UNION LAW, language: English, abstract: Data exclusivity in pharmaceuticals is one of the best protection systems among other type of regulatory drug product exclusivities such as patent protection, patent term extension and some other type of marketing exclusivities.Data exclusivity provides the right holder protection on his undisclosed information, in particular the results of tests in humans and animals and clinical trials which are given to the national authorities in order to obtain marketing approval for the drug product for which the application is made. In this regard data exclusivity means that, the second applicant can not use or rely on that data during the exclusive time period in order to obtain marketing approval for the same drug product which was already granted marketing approval first time. Like the second applicant, national regulatory authorities also can not rely on that data in order to grant marketing approval to the second applicant for the same drug product during that exclusive time period. By this reason data exclusivity differs from other type of drug product marketing exclusivities since marketing exclusivity in pharmaceutical drug products may last after data exclusivity time period expires like in the EU system. In the EU normally, while there is 8 year data exclusivity, marketing exclusivity is 10 year. Also data exclusivity differs from patent protection. In part one; firstly the focus is on the regulatory drug product exclusivities and then data exclusivity generally. In part two; data exclusivity is analyzed extensively in international law, in the EU law, in the U.S. law and lastly in Turkish law. 84 pp. Englisch.

Taschenbuch. Condizione: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Turkey has recently achieved a remarkable economic growth. In this regard, it is easily said that EU Member States might benefit from commercial, educational, cultural and touristic visits of Turkish people. However, Turkey is currently the only EU candidate county whose citizens are obliged to get a visa. The Schengen regime and restrictions concerning the freedom of movement for workers, freedom of establishment and, freedom to provide and receive services present a significant obstacle to the strengthening of relations between two sides. Association agreements and their additions with third countries such as the ones with Turkey are primary legal sources of EU legislation and so directly applicable; additionally, standstill clauses laid down in these sources protect previously given and acquired rights of citizens of both contracting parties. In recent years, by virtue of its decisions, the ECJ has performed a very significant function through condemning EU members to pay, which states do not adapt EU Law into their domestic law, not fully reflect it or not adapt it in time. Thus, it should be beneficial to remember and keep in mind some details about these rights and freedoms. 112 pp. Englisch.

Taschenbuch. Condizione: Neu. This item is printed on demand - Print on Demand Titel. Neuware -Turkey has recently achieved a remarkable economic growth. In this regard, it is easily said that EU Member States might benefit from commercial, educational, cultural and touristic visits of Turkish people. However, Turkey is currently the only EU candidate county whose citizens are obliged to get a visa. The Schengen regime and restrictions concerning the freedom of movement for workers, freedom of establishment and, freedom to provide and receive services present a significant obstacle to the strengthening of relations between two sides. Association agreements and their additions with third countries such as the ones with Turkey are primary legal sources of EU legislation and so directly applicable; additionally, standstill clauses laid down in these sources protect previously given and acquired rights of citizens of both contracting parties. In recent years, by virtue of its decisions, the ECJ has performed a very significant function through condemning EU members to pay, which states do not adapt EU Law into their domestic law, not fully reflect it or not adapt it in time. Thus, it should be beneficial to remember and keep in mind some details about these rights and freedoms.Books on Demand GmbH, Überseering 33, 22297 Hamburg 112 pp. Englisch.

Taschenbuch. Condizione: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - Turkey has recently achieved a remarkable economic growth. In this regard, it is easily said that EU Member States might benefit from commercial, educational, cultural and touristic visits of Turkish people. However, Turkey is currently the only EU candidate county whose citizens are obliged to get a visa. The Schengen regime and restrictions concerning the freedom of movement for workers, freedom of establishment and, freedom to provide and receive services present a significant obstacle to the strengthening of relations between two sides. Association agreements and their additions with third countries such as the ones with Turkey are primary legal sources of EU legislation and so directly applicable; additionally, standstill clauses laid down in these sources protect previously given and acquired rights of citizens of both contracting parties. In recent years, by virtue of its decisions, the ECJ has performed a very significant function through condemning EU members to pay, which states do not adapt EU Law into their domestic law, not fully reflect it or not adapt it in time. Thus, it should be beneficial to remember and keep in mind some details about these rights and freedoms.

Taschenbuch. Condizione: Neu. Data Exclusivity in Pharmaceutical Drug Products | Ali Demirba¿ | Taschenbuch | 84 S. | Englisch | 2019 | GRIN Verlag | EAN 9783346005762 | Verantwortliche Person für die EU: BoD - Books on Demand, In de Tarpen 42, 22848 Norderstedt, info[at]bod[dot]de | Anbieter: preigu Print on Demand.

Buch. Condizione: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware 206 pp. Englisch.

Buch. Condizione: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering.

Buch. Condizione: Neu. Gender, Class, and Respectability in Leisure | Understanding Women's 'Free Time Activities' in Modern Turkey | Gökben Demirba¿ | Buch | Einband - fest (Hardcover) | Englisch | 2024 | Routledge | EAN 9781032650173 | Verantwortliche Person für die EU: Libri GmbH, Europaallee 1, 36244 Bad Hersfeld, gpsr[at]libri[dot]de | Anbieter: preigu Print on Demand.