S.L. 458.36 Art. 11AQuality control testing in the United Kingdom. S.L. 458.34.

With regard to quality control testing, carried out in parts of the United Kingdom other than Northern Ireland, regarding medicinal products included in the list referred to in regulation 5A

of the Medicines (Marketing Authorisation) Regulations other than those authorised by the Commission, until the 31st December 2024, the Licensing Authority, may consider there is a justifiable case within the meaning of regulation 11(1)(b), without carrying out a case-by-case assessment provided that:

(a) each batch of the medicinal products concerned is released by a qualified person on a site in the Union or in Northern Ireland or by a qualified person on a site in parts of the United Kingdom other than Northern Ireland applying quality standards that are equivalent to those laid down in regulation 11;

(b) the establishment designated by the third party conducting the quality control testing is supervised by the competent authority of the United Kingdom, including by performing on-the-spot checks;

(c) where the batch release is carried out by a qualified person who resides and operates in parts of the United Kingdom other than Northern Ireland, the manufacturing authorisation holder declares that it does not have at its disposal a qualified person who resides and operates in the Union on the 20th April 2022.