S.L. 458.34 Art. 5AObligations of the authorisation holder. S.L. 458.35. S.L. 458.36.

The derogations set out in regulations 4A and 5(1) (b), regulations 4 and 22 of the Pharmacovigilance Regulations, and regulations 11A, 11B, 11C and 11D of the Manufacture and Importation of Medicinal Products for Human Use Regulations shall not affect the obligations of the marketing authorisation holder to ensure the quality, safety and efficacy of the medicinal product placed on the market as laid down in these regulations.