25 October 2007 /Authorisation and supervision
New application forms for the authorisation of manufacture, import and wholesale distribution of medicinal products
The Danish Medicines Agency has published new application forms for authorisation of companies to manufacture, import and wholesale distribute medicinal products (authorisation under section 39 of the Danish Medicines Act, see the factbox to the right).
19 June 2007 /Authorisation and supervision
The Council and the European Commission have approved a number of new proposals from the European Parliament for a regulation on advanced therapy medicinal products, including 'tissue engineering'.
23 May 2007 /Authorisation and supervision
The Danish Medicines Agency would like to specify the rules on release and distribution of medicinal products imported into Denmark from countries outside the EU/EFA (third countries) with the object of selling or dispensing the products according to a compassionate use permit.
01 May 2007 /Authorisation and supervision
The Danish Medicines Agency has become aware that the sperm bank A.I. Sædbank sells donated sperm via its. website: www.saedbank.com. The sperm bank is not authorised by the Danish Medicines Agency and therefore the sale of the sperm from the website is unlawful.