Traduction de «Factor II-deficient plasma » (Anglais → Français) :

Since 1989, blood and plasma used for the manufacturing of plasma-derived medicinal products (i.e. albumin, coagulation factors, immunoglobulins) have been covered by EU pharmaceutical legislation.

In general, the fact that deficient management or control systems were improved immediately after the deficiencies were reported to the Member State is not considered as a mitigating factor when assessing the financial impact of the systemic irregularities before the improvement was made.

For example, where the deficiencies arose from difficulties in the interpretation of Community rules or requirements (except in cases where it should reasonably be expected that the Member State raise such difficulties with the Commission), and the national authorities took effective steps to remedy the deficiencies as soon as they were brought to light, this mitigating factor may be taken into account and a lower rate or no correction may be proposed.

Since 1989, blood and plasma used for the manufacturing of plasma-derived medicinal products (i.e. albumin, coagulation factors, immunoglobulins) have been covered by Community pharmaceutical legislation.

(3) Whereas missions on BSE-related issues have been carried out in Portugal by the Commission Office for Veterinary and Phytosanitary Inspection and Control from 7 to 12 July 1996 and by the Food and Veterinary Office of the Commission from 15 to 21 June 1997 and from 11 to 15 May 1998; whereas those missions contributed to the assessment of the application and effectiveness of measures to protect against BSE; whereas those missions concluded that, despite important improvements, not all risk factors were adequately managed; whereas a follow-up mission was conducted by the food and Veterinary Office from 28 September to 2 October 199 ...[+++]8; whereas that mission confirmed most of the findings of the previous missions and observed, despite an overall improvement, certain continued shortcomings in the enforcement of the measures to control the risk factors; whereas the sharp increase in the incidence of BSE, in particular since June 1998, raises serious concerns with regard to the development of the disease in the near future; whereas on the basis of that mission it is concluded that due to deficiencies existing until very recently in the implementation of Community legislation on identification and registration of animals, and of measures on TSE surveillance and BSE eradication, no adequate guarantees can be provided regarding the BSE history of the herds of origin and herds through which bovine animals pass and regarding the dams of bovine animals;

1. By way of derogation from Article 34 of Directive 75/319/EEC, and subject to the provisions of this Directive, Directives 65/65/EEC and 75/319/EEC shall aplly to medicinal products based on blood constituents which are prepared industrially by public or private establishments, hereinafter referred to as 'medicinal products derived from human blood or human plasma'; these medicinal products include, in particular albumin, coagulating factors and immunoglobulins of human origin.