Directive of the European Parliament and of the Council 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products (12) and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (13) require that, with only minor exceptions, all veterinary medicinal products that are placed on the market within the Community are to hold a marketing authorisation.

(31) Directive 2001/82/EC of 6 November 2001 of the European Parliament and of the Council on the Community code relating to veterinary medicinal products and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency , require that, with only minor exceptions, all veterinary medicinal products that are placed on the market within the Community are to hold a marketing authorisation.

(31) Directive 2001/82/EC of 6 November 2001 of the European Parliament and of the Council on the Community code relating to veterinary medicinal products and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency , require that, with only minor exceptions, all veterinary medicinal products that are placed on the market within the Community are to hold a marketing authorisation.

6.3. If available, the following signals in addition to the required freeze-frame information must be made available on demand through the serial port on the standardised data link connector, if the information is available to the on-board computer or can be determined using information available to the on-board computer: diagnostic trouble codes, engine coolant temperature, injection timing, intake air temperature, manifold air pressure, air flow rate, engine speed, pedal position sensor output value, calculated load value, vehicle speed and fuel pressure.

This communication also points out that, as part of the reform of the Community code relating to medicinal products for human use, the Council's common position suggests the possibility of introducing a marketing authorisation application for a generic and to grant this authorisation in the last two years of the data protection period of the reference product for all products except those falling within the mandatory scope of the centralised procedure.

6.5.1.2. If available, the following signals in addition to the required freeze-frame information must be made available on demand through the serial port on the standardized data link connector, if the information is available to the on-board computer or can be determined using information available to the on-board computer: diagnostic trouble codes, engine coolant temperature, fuel control system status (closed-loop, open-loop, other), fuel trim, ignition timing advance, intake air temperature, manifold air pressure, air flow rate, engine speed, throttle position sensor output value, secondary air status (upstream, downstream or atmosp ...[+++]here), calculated load value, vehicle speed and fuel pressure.