EU regulation implemented in Norwegian legislation
“Pharma-package I” has been implemented into Norwegian legislation and consists of the following three Directives and one Regulation.
Directive 2004/24 traditional herbal medicinal products
- Directive 2004/27 relating to medicinal products for human use
- Directive 2004/28 relating to veterinary medicinal products
- Regulation 726/2004 laying down Community procedure for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
This also implies that Directive 2001/83/EF on the Community code relating to medicinal products for human use has been implemented in Norwegian legislation. The implementation of the mentioned directives and regulation in Norwegian legislation impacts the following amendments:
- Grounding of a simplified registration procedure for traditional herbal medicinal products, and homeopathic medicines for human and veterinary use (with a regulated overlapping period of 7 years for homeopathic medicines).
- The data protection period for medicines is now 8 years long. A marketing protection period of 10 years is also regulated (includes the 8 years data protection period).
- A one year data protection period for further development on older medicines, where the development is essential.
- Formal introduction of Decentralised procedure for authorisation of medicinal products.
- Extension of which medicinal products that may be authorised through Centralised Procedure.
- Introduction of “Sunset Clause” which indicates the termination of registration either after a three year intermission period with no marketing of the product or after the failure of placing the medicinal product on the market within a three year period from marketing authorisation is given. The three year period runs from the time the medicinal product could have been marketed. For new products this means from the time price is set (usually one month after the authorisation is given). For medicinal products with marketing authorisation dated prior to 12 January 2010, the three year period starts earliest from 12 January 2010.
- The holders of the marketing authorisation are obliged to inform about the marketing of the medicinal product and of any eventual delivery problems.
- Obligatory braille on the packaging. For those products that obtained marketing authorisation prior to 12 January 2010 the braille must be inserted on the packaging by 12 January 2012.
- Introduction of the European Reference Product: i.e. an application for a marketing authorisation of a generic medicinal product with a reference to a medicinal product that has previously obtained an authorisation within the EEA-area. The product of reference need not be authorised in the country where the generic product applies for marketing authorisation.
“Pharma-package I” is implemented in Norwegian legislation in the regulation listed below:
In addition to the above mentioned amendments, the following EU-regulation is implemented in the Norwegian regulation on medicinal products:
- Regulation 1905/2005 on fees payable to the European Medicines Agency
- Regulation 2049/2005 on rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by very small, small and medium-sized enterprises
- Regulation 507/2006 on the conditional marketing authorisation for medicinal products for human use
- Regulation 1394/2007 on advanced therapy medicinal products
Should you need further information, please contact:
Inger Heggebø,
Senior adviser,
Telephone: + 47 22 89 77 44,
E-mail: inger.heggebo[at]noma.no
Catrine Hodnesdal Karlöf,
Lawyer,
Telephone: +47 22 89 75 60,
E-mail: catrine.karlof[at]noma.no
Sist gjennomgått: 11.02.2010
Første gang publisert: 11.02.2010