proprietary medicinal product

Proprietary medicinal product being defined as "Any ready-prepared medicinal product placed on the market under a special name and in a special pack."

Two days later the Committee for Proprietary Medicinal Products recommended to the European Commission that marketing approval of Trovan be suspended for a year.

The main article 3 of the directive requires that a Proprietary medicinal product could not be marketed within the community without prior authorisation of the competent authority of at least one member state.

In 2003, the manufacturer of Prozac (fluoxetine) was required by the Committee for Proprietary Medicinal Products to remove PMDD from the list of indications for fluoxetine sold in Europe.

Dr. Daniel Brasseur, chairman of the Committee for Proprietary Medicinal Products, an advisory committee to the European Commission, said, "I'm aware there is a French concern about Eprex for the time being."

Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products.

The answer: benfluorex was discussed in 1998 in the Committee for Proprietary Medicinal Products, now called the Committee for Medical Products for Human Use, of the European Medicines Agency, and subsequently in the Pharmacovigilance Working Party.

We therefore welcome the Commission's proposal to create a Committee for Herbal Medicinal Products, which is autonomous and separate from the Committee on Proprietary Medicinal Products, which will be responsible for the regulation and monitoring of all aspects of herbal medicines.

This process included an assessment by the Committee for Proprietary Medicinal Products (CPMP, now CHMP), and a subsequent approval by the national health agencies; in Germany, for example, in 1988 by the Paul Ehrlich Institute in Frankfurt.

The advice that has been given to the Commission from the relevant scientific committees, in particular the Committee for Proprietary Medicinal Products, on the risk of these forms of CJD, is that there are no specific grounds for possible recall or quarantine of batches of plasma-derived products.