The Pharma Legal Handbook: Regulatory, Pricing & Reimbursement Europe
The Pharma Legal Handbook: Regulatory, Pricing & Reimbursement Europe answers essential questions about regulatory, pricing and reimbursement issues in 23 countries:
Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Romania, Russia, Slovakia, Spain, Switzerland, Poland, Portugal, Ukraine & United Kingdom
Prepared in association with leading local law firms and consultancies, it is a must-have for any company operating in or looking to enter these niches in any of these countries.
Publisher: White Publishing Resources
Bulgaria (PharmDedict, Kinstellar)
Croatia (Danijel Pribanic)
Czech Republic (P/R/K)
Denmark (Gorrissen Federspiel)
Estonia, Latvia, Lithuania (TGS Baltic)
Germany (Heuking, Kühn, Lüer & Wojtek)
Ireland (Mason, Hayes & Curran)
Italy (DLH Piper)
Poland (DLH Piper)
Romania (Musat & Asociatii)
Spain (Faus & Moliner)
Switzerland (Wenger Plattner)
Ukraine (Sayenko Karenko)
United Kingdom (Clyde & Co)
Publication Date: October 2019
1. Regulatory, Pricing, and Reimbursement Overview
- What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
- What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
- What are the steps to obtain authorization to develop, test, and market a product?
- What are the approximate fees for each authorization?
- For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
- How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
- How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?
- How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?
- What is the potential range of penalties for noncompliance?
- Is there a national healthcare system? If so, how is it administered and funded?
- How does the government (or public) healthcare system function with private sector healthcare?
- Are prices of drugs and devices regulated and, if so, how?
- How are drugs and devices used by patients paid for? What roles do public and private payers play?
- Who dispenses drugs and devices to patients and how are those dispensers compensated?
- What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?