Content Overview
1. Marketing, Manufacturing, Packaging and Labelling 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 pro- cess for the marketing of gener- ic 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 US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
- What is the inspection regime for manufacturing facilities?
- Are manufacturing facilities open for inspection by foreign in- spectors 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 items may not be included in labeling and packaging?
- What additional information may 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?