Hvis den for markedsføringen ansvarlige agter at foretage ændringer i de i artikel 6 og 9 omhandlede oplysninger og dokumenter, skal vedkommende indgive en ansøgning til agenturet.
If the person responsible for placing the medicinal product on the market proposes to make any alteration to the information and particulars referred to in Articles 6 and 9, he shall submit an application to the Agency.