Karya Ilmiah

DISERTASI (0064) - Prinsip Hukum Pengaturan Perizinan Kefarmasian

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This dissertation is the result of the research on the implementation of legal
principles in pharmaceutical license in Indonesia. The objective of the research is to
find basis for legal reform, especially pharmaceutical regulation that guarantee
manufacturing, distribution, and medicine services to warrant availability of safe,
beneficial, excellent and affordable medicines and warranty the quality of pharmacy
professionals. In practically existing legal form in pharmaceutical license, namely
Ministry regulation and the regulation of Head of the National Drug and Food
Monitoring Agency (BPOM) which those existing regulation could not be
implemented well. Based on the legal principles of legislative drafting including the
principle of clean government and the principles of good governance, then there are
some the regulations of pharmaceutical license disharmonize with the legal
principles namely principle of institutional or appropriate law maker, principle of
harmony between types, hierarchies and substance and principle of efficiency and
effectiveness in order to solve the problem. It is argue that with. Hence, legal reform
in pharmaceutical regulation is neede as legal basis to warrant availability of safe,
beneficial, excellent and affordable medicines, as well as strengthen the law
enforcement pharmaceutical license matter.

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Ketersediaan

090810017

0064

Ruang Disertasi

Tersedia

Informasi Detail

Judul Seri

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No. Panggil

0064

Penerbit

Surabaya : Fakultas Hukum Unair., 2013

Deskripsi Fisik

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Bahasa

Indonesia

ISBN/ISSN

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Klasifikasi

NONE

Tipe Isi

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Tipe Media

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Tipe Pembawa

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Edisi

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Subjek

HUKUM PERIZINAN

Info Detail Spesifik

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Pernyataan Tanggungjawab

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Versi lain/terkait

Lampiran Berkas

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