Medicinal product regulation and product liability: Country Q&A tool

Search the Country Q&A in the Life Sciences Guide/Medicinal product regulation and product liability section by question and jurisdiction.

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Step 3: Scroll down to view answers and check law stated dates for each jurisdiction.

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Regulatory overview

1. What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?
 
2. Briefly outline how biologicals and combination products are regulated in your jurisdiction.
 
3. Briefly outline how medical devices and diagnostics are regulated in your jurisdiction. Is there any specific regulation of health IT issues and mobile medical applications?
 

Pricing, state funding and reimbursement

4. What is the structure of the national healthcare system, and how is it funded?
 
5. How are the prices of medicinal products regulated?
 
6. When is the cost of a medicinal product funded by the state or reimbursed? How is the pharmacist compensated for his dispensing services?
 

Clinical trials

7. Outline the regulation of clinical trials.
 

Manufacturing

8. What is the authorisation process for manufacturing medicinal products?
 

Marketing

Authorisation and abridged procedure

9. What is the authorisation process for marketing medicinal products?
 
10. What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorisation? Are there further conditions concerning how the drug is distributed and accessible to patients?
 
11. Which medicinal products can benefit from the abridged procedure for marketing authorisations and what conditions and procedure apply? What information can the applicant rely on?
 
12. Are foreign marketing authorisations recognised in your jurisdiction?
 

Parallel imports

13. Are parallel imports of medicinal products into your jurisdiction allowed?
 

Restrictions on dealings with healthcare professionals

14. What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners?
 
15. What are the restrictions on selling medicinal products? Are there any specific regulations for the sale of medicinal products on the internet, by e-mail and by mail order?
 

Advertising

16. What are the restrictions on advertising medicinal products?
 

Data protection

17. Do data protection laws impact on pharmaceutical regulation in your jurisdiction?
 

Packaging and labelling

18. Outline the regulation of the packaging and labelling of medicinal products.
 

Product liability

19. Outline the key regulators and their powers in relation to medicinal product liability.
 
20. Are there any mandatory requirements relating to medicinal product safety?
 
21. Outline the key areas of law applicable to medicinal product liability, including key legislation and recent case law.
 
22. Who is potentially liable for defective medicinal products?
 
23. What defences are available to product liability claims? Is it possible to limit liability for defective medicinal products?
 
24. How can a product liability claim be brought?
 
25. What remedies are available to the claimant? Are punitive damages allowed for product liability claims?
 

Reform

26. Are there proposals for reform and when are they likely to come into force?
 
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