The Pharma Legal Handbook: Southern Europe (Bulgaria, Croatia, Greece, Italy, Portugal, Romania & Spain)
Join industry executives in staying informed on pharma regulations in the Southern European countries of Bulgaria, Croatia, Greece, Italy, Portugal, Romania & Spain.
Regulation, Pricing, Clinical and Preclinical Trials, Marketing, Manufacturing, Trademarks, Patents, and more!
Get your pharmaceutical legal and regulatory questions answered in The Pharma Legal Handbook – a must-have guide for any company operating in the country or looking to enter the market.
If legal handbook content is updated, you will receive a free updated PDF for up to one year after purchase.
Version Updated December 2021
Publisher: White Publishing Resources
Publication Date: December 2021
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?
2. Preclinical & Clinical Trial Requirements
- Outline the progression from drug/device discovery to preclinical trials to clinical trials to marketing approval.
- What authorizations are required for each stage in research, development, and testing?
- Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
- How are clinical trials funded?
- What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
- What are the requirements for consent by participants in clinical trials?
- May participants in clinical trials be compensated?
- How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
- What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
- What is the authorization process for the marketing of generic versions of these products?
- What are the typical fees for marketing approval?
- What is the period of authorization and the renewal process?
- What are the requirements, if any, for post-approval pharmacovigilance?
- Are foreign marketing authorizations recognized?
- Are parallel imports of medicines or devices allowed?
- What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
- How is the manufacturing of medicines and devices regulated and by which agencies?
- Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?
- What is the inspection regime for manufacturing facilities?
- Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
- What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
- What information must be included in medicine and device labeling?
- What additional information may be included in labeling and packaging?
- What items may not be included in labeling and packaging?
- What are the restrictions and requirements for the marketing and advertising of medicines and devices?
- Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
- What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?
- May medicines and devices be advertised or sold directly to consumers?
- How is compliance monitored?
- What are the potential penalties for noncompliance?
4. Traditional Medicines and Over-the-Counter Products
- What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
- Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
- What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
- What are the regulatory requirements for over-the-counter (non-prescription) medications?
- Are there any limitations on locations or channels through which OTC products may be sold?
- What health, advertising, and marketing claims may be made for OTC products?
- Can OTC products be marketed or advertised directly to the public?
- What is the mechanism by which a prescription-only product can be converted to an OTC product?
- What are the requirements for the importation of either traditional medicines or OTC products?
5. Product Liability
- What types of liability are recognized in your jurisdiction?
- How do these types of liabilities apply to the manufacturers of medicines and devices?
- Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
- How can a liability claim be brought?
- What defenses are available?
6. Patents and Trademarks
- What are the basic requirements to obtain patent and trademark protection?
- What agencies or bodies regulate patents and trademarks?
- What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
- How can patents and trademarks be revoked?
- Are foreign patents and trademarks recognized and under what circumstances?
- Are there any non-patent/trademark barriers to competition to protect medicines or devices?
- Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
- Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
7. Regulatory Reforms
- Are there proposals for reform or significant change to the healthcare system?
- When are they likely to come into force?