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Understanding Pharmaceutical Law
Pharmaceutical Law, a legal document governing the pharmaceutical field, adapts its scope over time to regulate specific activities. Despite its general focus on the pharmaceutical sector, the regulations may vary based on the period, encompassing specific details within the 2016 Pharmaceutical Law.
Exploring the Dimensions of Pharmaceutical Legislation
The inaugural release of Pharmaceutical Law took place in 2005, becoming effective on October 1, 2005.
* Download the Latest Pharmaceutical Law HERE
2. Introduction to the Current Pharmaceutical Law
On January 1, 2017, the latest Pharmaceutical Law, 2016 (Law No. 105/2016/QH13), approved by the National Assembly on April 6, 2016, came into effect, replacing the 2005 Pharmaceutical Law. This is the most recent Pharmaceutical Law as of the current date. Immediately upon its effectiveness, Decree No. 54/2017/NĐ-CP guiding the Pharmaceutical Law was also issued.
The structure of the 2016 Pharmaceutical Law comprises 116 Articles divided into 14 Chapters. Compared to the 2005 Pharmaceutical Law, it adds 04 chapters, removes 01 chapter - incorporating this content into relevant chapters; and increases by 43 Articles.
The regulatory scope of the 2016 Pharmaceutical Law: Article 1 of this Law clearly outlines the regulatory scope, which includes:
+ State policies on pharmaceuticals and the development of the pharmaceutical industry;
+ Pharmaceutical profession;
+ Registration, circulation, withdrawal of drugs and pharmaceutical materials, herbal medicine, and traditional medicines;
+ Prescription and medication usage;
+ Drug information, pharmacovigilance, and drug advertising.
+ Clinical pharmacy;
+ Drug management in healthcare facilities;
+ Clinical trials and bioequivalence testing of drugs;
+ Quality management of drugs and pharmaceutical materials;
+ Price management of drugs.
It can be observed that the scope of the 2016 Pharmaceutical Law is quite extensive, encompassing nearly all activities revolving around drugs and pharmaceutical materials.
Content and regulatory scope of the 2016 Pharmaceutical Law
3. Basic Content of the 2016 Pharmaceutical Law
From the perspective of organizations, individuals both within and outside the country involved in pharmaceutical activities, readers should focus on some key content, including:
- Regulatory scope, applicable entities.
- State policies on the pharmaceutical sector and the development of the pharmaceutical industry. Note: Certain behaviors are strictly prohibited.
- State management of drug prices.
- Regulations on herbal medicine and traditional medicines.
- Regulations on pharmaceutical professional certificates; certificates of eligibility for drug business; and drug registration.
- Regulations on clinical pharmacy work; conducting clinical trials.
Above are the latest updates on the Pharmaceutical Law that we have compiled and shared with our readers. The law is assessed to be effectively ensuring the smooth operation of activities in the pharmaceutical sector, contributing to the development of the pharmaceutical industry both domestically and internationally.
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