Subject to paragraphs (2) and (3), these Regulations do not apply to any activity which is covered by a written consent given by a competent authority of an EEA State in accordance with Article 15(3), 17(6) or 18(2) of Directive (EC) No 2001/18 of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms.

The written consent referred to in paragraph (1) must be valid immediately before IP completion day.

Any activity covered by the consent referred to in paragraph (1) must be conducted in accordance with any obligations, conditions or limitations attached to that consent.

Subject to paragraphs (5) and (6), these Regulations do not apply to any genetically modified organisms which are cultured, stored, transported, destroyed, disposed of or used, where such organisms are, or are contained in, a medicinal product for human or veterinary use marketed in accordance with an authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

The marketing authorisation referred to in paragraph (4) must be valid immediately before IP completion day.

Any marketing authorisation referred to in paragraph (4) must be conducted in accordance with any obligations, conditions, restrictions, requirements or limitations attached to that authorisation.