The Life Sciences Country Q&A tool enables subscribers to search the PLC Cross-border Life Sciences Handbook Country Q&As by question and jurisdiction. Simply select the questions and the jurisdictions that you are interested in and click the "submit" button. Please note that the law stated dates for each jurisdiction covered may not be the same. To check the law stated dates for each jurisdiction, please visit the individual article.
To which authority must the application be made?
What conditions must be met to obtain authorisation?
Are there specific restrictions on foreign applicants?
What are the key stages and timing?
What fee must be paid?
How long does authorisation last and what is the renewal procedure?
Monitor compliance with manufacturing authorisations?
Impose penalties for a breach of a manufacturing authorisation?
Which legislation and regulatory authorities regulate clinical trials?
What authorisations are required and how is authorisation obtained?
What consent is required from trial subjects and how must it be obtained?
What other conditions must be met before the trial can start (for example, the requirement for a sponsor and insurance cover)?
What are the procedural requirements for the conduct of the trial (for example, using certain medical practices and reporting requirements)?
To which authority must the application be made?
What conditions must be met to obtain authorisation?
What are the key stages and timing?
What fee must be paid?
How long does authorisation last and what is the renewal procedure?
Which medicinal products can benefit from the abridged procedure (for example, generics)?
What conditions must be met?
What procedure applies and what information can the applicant rely on?
Monitor compliance with marketing authorisations?
Impose penalties for a breach of a marketing authorisation?
Which legislation applies and which regulatory authority enforces it?
What types of medicinal product cannot be advertised?
What restrictions apply to advertising that is allowed?
Which legislation applies and which regulatory authority enforces it?
What information must the packaging and/or labelling contain?
What other conditions must be met (for example, information being stated in the language of your jurisdiction)?
To which authority must the application be made?
What fee must be paid?
What are the key stages and timing?
To which authority must the application be made?
What fee is payable?
What are the key stages and timing?
Under what laws can liability arise (for example, contract, tort or statute)?
What is the substantive test for liability?
Who is potentially liable for a defective product?