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 contains alcohol.
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.