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.
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.