Regulation 1A Modification of provisions of the Annex to Commission Directive 2005/62/ECF1

For the purposes of these Regulations as they apply in relation to Great Britain, the Annex to Commission Directive 2005/62/EC is to be read with the modifications specified in the following paragraphs.

Paragraph 2.5 is to be read as if the reference to compliance with the Directives mentioned in that paragraph was a reference to compliance with the requirements which those Directives would require to be imposed if those Directives formed part of domestic law.

Paragraph 4.3 is to be read as if the reference to—

Paragraph 6.1.1 is to be read as if the reference to the requirements set out in Annexes II and III to Directive 2004/33/EC were a reference to the requirements set out in Parts 2 and 3 of the Schedule.

Paragraph 6.2.2 is to be read as if the reference to third countries were a reference to countries other than the United Kingdom.

Paragraph 6.3.2 is to be read as if the reference to the requirements set out in Annex IV to Directive 2002/98/EC were a reference to the requirements set out in regulation 7(7).

Paragraph 6.3.3 is to be read as if the reference to a test mentioned in Annex IV to Directive 2002/98/EC were a reference to a test for the infections mentioned in regulation 7(7)(c).

Paragraph 6.5.2 is to be read as if—

Paragraph 6.5.3 is to be read as if the reference to compliance with Article 7 of Directive 2004/33/EC were a reference to compliance with regulation 7(3) (in relation to labelling), regulation 8 and paragraph 3.2 of Part 4 of the Schedule.

Paragraph 6.6.1 is to be read as if the reference to mandatory requirements set out in the Directive were a reference to the requirements set out in these Regulations.

Paragraph 7.1 is to be read as if the reference to “Directive 2003/94/EC” were to “the Good Manufacturing Practice Directive, within the meaning of paragraph (a) of the definition of that term in regulation 8(1) of the Human Medicines Regulations 2012.

Paragraph 9.1 is to be read as if the reference to the standards set out in Annex V of Directive 2004/33/EC were a reference to the standards set out in Part 5 of the Schedule.

Paragraph 9.2 is to be read as if the reference to regulatory requirements were a reference to the requirements in regulation 12B.

Paragraph 10.1 is to be read as if for “according to approved procedures” there were substituted “ and in accordance with the procedures required by the quality system established and maintained by the blood establishment ”.