xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"
The following conditions apply in addition to the general conditions laid down in Chapter I.
Raw material
Only blood coming under paragraph 1(a) and (b) of Article 6 may be used for the production of blood products.
Processing standards
Blood products must have been submitted:
to any of processing methods 1 to 5 or 7; or
to a method and parameters which ensure that the product complies with the microbiological standards set in Chapter I, paragraph 10.
Importation
Member States must authorise the importation of blood products if they:
[F1come from third countries that appear on the list of part V and part VI of Annex XI as appropriate;]
come from a processing plant that appears on the list referred to in Article 29(4);
have been produced in accordance with this Regulation; and
[F1if it is accompanied by a health certificate that conforms to the model set out in Chapter 4(B) of Annex X.]