It will be developed in stages, priority being given to medicinal products
authorised the European Agency for the Evaluation of Medicinal Products
, and subsequently be extended to include any medicinal product
marketed in the European Union.
In addition to this new obligation, the option is opened more widely for companies to use the centralised system, whenever the medicinal product
is a significant innovation from a therapeutic, scientific or technical point of view or is of interest at EU level to patients.Each application for authorisation must take account of the unique, EU nature of the authorisation requested.
- a homeopathic medicinal product
lawfully placed on the market in the
Under the Regulation proposed in October 2004, all new requests for authorisation for medicinal products
should be accompanied by a "paediatric investigation plan" (specifying conditions for authorisation for use of the medicinal product
in the treatment of children).
3) was revised in order to include a reference to the "Guideline on excipients in the label and package leaflet of medicinal products
for human use" and to the need to put an appropriate warning on the label in case a herbal medicinal product
Regarding therapeutic indications for herbal medicinal products
with a well-established medicinal use, a standard statement "herbal medicinal product
..." is proposed, followed by a specific statement, e.g.
Apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, a product cannot be regarded as a 'medicinal product
' under Article 1(2)(b) of the Directive, where, having regard to its composition (including its content in active substances) and if used as intended, it is incapable of appreciably restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.
Further, the ECJ rejected the argument of Poland that the importation and the placing on the national market of a medicinal product
cheaper than the equivalent medicinal product
which has obtained marketing authorisation may be justified by financial considerations inasmuch as they are necessary both in order to ensure the financial stability of the national social security system and to allow patients who have only limited financial means to have access to the treatment which they need.
Schaber, Ph.D., executive vice president and COO of Discovery, stated, "The granting of Orphan Medicinal Product
designation together with the United States FDA's acceptance of the Surfaxin NDA, increases our confidence in the potential for Surfaxin to become a new, worldwide standard of care for the prevention and treatment of RDS.
Orphan Medicinal Product
designation also allows for protocol assistance free of charge on clinical trials, a reduced Marketing Authorisation Application (MAA) filing fee and the potential for grant funding.