Life sciences: Country Q&A tool

Search the Country Q&A in the Life Sciences Multi-jurisdictional Guide by question and jurisdiction.

Step 1: Check the boxes to select the questions and the jurisdictions for comparison.
Step 2: Click the "submit" button.
Step 3: Scroll down to view answers and check law stated dates for each jurisdiction.

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Regulatory overview

1. What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)?
 

Pricing and state funding

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

Manufacturing

5. What is the authorisation process for manufacturing medicinal products?
 
6. What powers does the regulator have in relation to manufacturing authorisations?
 

Clinical trials

7. Outline the regulation of clinical trials.
 

Marketing

Authorisation and abridged procedure

8. What is the authorisation process for marketing medicinal products?
 
9. 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?
 
10. Are foreign marketing authorisations recognised in your jurisdiction?
 
11. What powers does the regulator have in relation to marketing authorisations?
 

Parallel imports

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

Restrictions

13. What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners?
 
14. What are the restrictions on marketing medicinal products on the internet, by e-mail and by mail order?
 

Advertising

15. What are the restrictions on advertising medicinal products?
 

Packaging and labelling

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

Traditional medicines

17. Outline the regulation of the manufacture and marketing of alternative or complementary medicinal products in your jurisdiction.
 

Patents

18. What are the legal conditions to obtain a patent and which legislation applies? Which products, substances and processes can be protected by patents and what types cannot be patent protected?
 
19. How is a patent obtained?
 
20. How long does patent protection typically last? Can monopoly rights be extended by other means?
 
21. How can a patent be revoked?
 
22. How is a patent infringed? How is a claim for patent infringement made and what remedies are available?
 
23. Are there non-patent barriers to competition to protect medicinal products?
 

Trade marks

24. What are the legal conditions to obtain a trade mark and which legislation applies? What cannot be registered as a trade mark and can a medicinal brand be registered as a trade mark?
 
25. How is a trade mark registered?
 
26. How long does trade mark protection typically last?
 
27. How can a trade mark be revoked?
 
28. How is a trade mark infringed? How is a claim for trade mark infringement made and what remedies are available?
 

Patent and trade mark licensing

29. Does a patent or trade mark licence agreement and payment of royalties under it to a foreign licensor have to be approved or accepted by a government or regulatory body?

Patent and trade mark conventions

30. Is your jurisdiction party to international conventions on patent and trade mark protection?
 

Product liability

31. Outline the scope of medicinal product liability law.
 
32. How can a product liability claim be brought?
 
33. What defences are available to product liability claims?
 
34. What remedies are available to the claimant? Are punitive damages allowed for product liability claims?
 

Reform

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