The Pharma Legal Handbook: Bulgaria
Join industry executives in staying informed on pharma regulations in Bulgaria.
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.
Prepared in association with regional pharmaceutical consultancy PharmDedict and Kinstellar, a leading independent law firm focused on emerging Europe and Central Asia.
If legal handbook content is updated, you will receive a free updated PDF for up to one year after purchase.
Version Updated June 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?