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10 January 2008 /Authorisation and supervision
New rules governing advanced therapy medicinal products
The proposed regulation on advanced therapy medicinal products, including tissue engineered products, was announced on the Danish Medicines Agency's website on 12 June 2007.
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10 January 2008 /Authorisation and supervision
General principles of the regulation on advanced therapy medicinal products
Regulation (EC) No 1394/2007 on advanced therapy medicinal products specifically governs gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineered products.
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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).
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19 June 2007 /Authorisation and supervision
New regulations for advanced therapy medicinal products, tissue engineering
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'.
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23 May 2007 /Authorisation and supervision
Import of medicinal products to be sold or dispensed according to a compassionate use permit
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.
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01 May 2007 /Authorisation and supervision
Warning: Unauthorised sale of donated sperm from the sperm bank A.I. Sædbank
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.
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/Authorisation and supervision
