Regulatory framework of pharmaceutical compounding and actual developments of legislation in Europe.
نویسندگان
چکیده
Pharmaceutical preparations are medicines that the pharmacist makes for the special needs of the patients that the pharmaceutical industry cannot comply for economic and logistic reasons. Pharmacy compounding is still an important component of pharmacy practice and a valuable therapeutical service that is an integrant part of the modern health care system, but its legislation is not harmonized among European and US countries. In 2011 the Committee of Ministers of the Council of Europe has adopted a Resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients. Aim of this resolution is to harmonize quality assurance and standards for pharmacy-made medicinal products among European countries and to pass the gap in quality assurance and standards between preparation in pharmacies and medicines prepared by the pharmaceutical industry. This article will analyze the actual rules and technical norms that regulate compounding activity and the expectations resultants from the new European and US laws.
منابع مشابه
The Legal Issues of Electronic Contracts in Australia
The internet has transformed the manner of conducting commercial transactions and has created regulatory gaps. These regulatory gaps may impact the effective development of electronic commerce. Attempts are being made to regulate electronic contracts both at the national and international level. The present research analyses these attempts, in particular the Electronic Transaction Legislation ...
متن کاملCompounding as a current therapeutic option in dermatology.
Compounding continues to play a key role in the treatment of skin conditions, despite the abundance of products made by the pharmaceutical industry. Right from the earliest days of dermatology, compounding proved very useful in the treatment of diseases for which no specific drugs were available. However, as new products came onto the market, this usefulness was called into question, and doubts...
متن کاملCalls for Stricter Legislation and Fear in the European Immigrant Community: Reflections of the Public Charge Debate Ongoing in the United States; Comment on “A Crisis of Humanitarianism: Refugees at the Gates of Europe”
In the editorial, “A Crisis of Humanitarianism: Refugees at the Gates of Europe,” Marianna Fotaki elegantly highlights the changing dynamics of governmental policy toward refugees, forced migrants into Europe and the move away from the principles of humanitarianism.1 The perceived threats to economy, securi...
متن کاملSunshine Policies and Murky Shadows in Europe: Disclosure of Pharmaceutical Industry Payments to Health Professionals in Nine European Countries
Relationships between health professionals and pharmaceutical manufacturers can unduly influence clinical practice. These relationships are the focus of global transparency efforts, including in Europe. We conducted a descriptive content analysis of the transparency provisions implemented by February 2017 in nine European Union (EU) countries concerning payments to health professionals, with du...
متن کاملRisk assessment and regulation of molecular farming - a comparison between Europe and US.
In this article, the general principles of genetically modified (GM) plant risk assessment and the regulatory framework for contained use and open field production of plant-made pharmaceuticals/plant-made industrials (PMP/PMI) are described. While significant progress has been made for the containment grown (plant cell culture) production of PMPs, with the first regulatory approval made by the ...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Health policy
دوره 117 3 شماره
صفحات -
تاریخ انتشار 2014