Before revision: Once a new active ingredient authorised, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations (changes to the existing marketing authorisation) and extensions shall also be granted an authorisation or be included in the initial marketing authorisation, being subject of an abridged application.Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
After revision: isOnce a new active ingredient authorised, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations (changes to the existing marketing authorisation) and extensions shall also be granted an authorisation or be included in the initial marketing authorisation, being subject of an abridged application.Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.