Archive for the ‘Business’ Tag

Discovery in the Netherlands

Discovery  in the Netherlands. Disclosure of documents in civil claims.

If a party needs documents from another party in the Netherlands article 843a Code of Civil Procedure Rules (DCPR) (right to inspection) might be a tool to gain access to these documents.

In short article 843a DCPR enables a party to gain insight in documents that are not at his disposal. For a claim under this article it is necessary that requirements mentioned in article 843a are met. The elements are as follows:

  • The claim has to regard existing documents
  • The documents must be at the disposal of, or in possession of, defendant
  • The documents must be sufficiently determined
  • The documents must bear relevance to a legal relationship in which plaintiff is a party
  • The plaintiff must have a legitimate interest in the inspection, a copy or extract (hereinafter jointly: copy) of the documents
  • Rejection of the claim only for serious reasons and
  • Rejection of the claim if in the interest of a proper administration of justice is also guaranteed without a copy.

If you need further information please contact Legaltree

The EU Register of Clinical Trials is launched Online.

On 22 March the EU register of clinical trails has been launched online
The aim is more transparency for patients and avoidance of unnecessary duplication of clinical trials

Clinical trials performed in the EU must be conducted by the EU Clinical Trials Directive (2001/20/EC) and implementing legislation. This legislation lays down principles and detailed guidelines for good clinical practice for investigating medicinal products for human use. It aims at ensuring a high level of protection of patient safety, as well as reliability and robustness of the data generated in a trial. To this end, the legislation and implementing guidance specify various aspects of clinical trials including:

* Information that must be submitted to the competent authorities and to the ethics committees
* Requirements for ‘informed consent’ of the clinical trial participants
* Requirements on safety monitoring and the reporting of adverse reactions
* Requirements on Good Clinical Practice, including the documentation, of the clinical trials
* Specific requirements on the products tested, including manufacturing and labelling
* The inspections of competent authorities and applicable procedures.

The Clinical Trials register has information about clinical trials authorised in the EU, whether they take place in one Member State or in several. It includes clinical trials conducted by both industry and research institutions. The information is rendered public once the clinical trial has been authorised.

The register also includes the clinical trials contained in a Paediatric Investigation Plan – the research and development program that aims to generate the data required to authorise a medicinal product for use in children. The clinical trials contained in such a Plan are published even if they are performed outside the EU.

The clinical trials register:
http://www.ClinicalTrialsRegister.eu

Further information:
http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm

Source: press release of RAPEX 22 March: http://europa.eu/rapid/pressReleasesAction.do?reference=IP/11/339&format=HTML&aged=0&language=en&guiLanguage=en