PART III

DISEASE AWARENESS, PREPAREDNESS AND CONTROL
TITLE I

DISEASE AWARENESS AND PREPAREDNESS
CHAPTER 3

Antigen, vaccine and diagnostic reagent banks

The establishment of Union antigen, vaccine and diagnostic reagent banks
Article 48
1
For listed diseases referred to in point (a) of Article 9(1) in respect of which vaccination is not prohibited by a delegated act adopted pursuant to Article 47, the Commission may establish and be responsible for managing Union antigen, vaccine and diagnostic reagent banks for the storage and replacement of stocks of one or more of the following biological products:
a
antigens;
b
vaccines;
c
vaccine master seed–stocks;
d
diagnostic reagents.
2
The Commission shall ensure that the Union antigen, vaccine and diagnostic reagent banks provided for in paragraph 1:
a
store sufficient stocks of the appropriate type of antigens, vaccines, vaccine master seed–stocks and diagnostic reagents for the specific listed disease in question, taking into account the needs of Member States estimated in the context of the contingency plans provided for in Article 43(1);
b
receive regular supplies and timely replacements of antigens, vaccines, vaccine master seed–stocks and diagnostic reagents;
c
are maintained and moved in conformity with the appropriate biosecurity, biosafety and bio–containment requirements laid down in Article 16(1) and in accordance with delegated acts adopted pursuant to Article 16(2);
3
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:
a
the management, storage and replacement of stocks of the Union antigen, vaccine and diagnostic reagent banks as provided for in paragraphs 1 and 2 of this Article;
b
the biosecurity, biosafety and bio–containment requirements for the operation of those banks, respecting the requirements provided for in Article 16(1) and taking into account the delegated acts adopted pursuant to Article 16(2).