Many manufacturers that require delivery intra-Europe use road transport to ensure that their APIs, clinical materials and biological samples arrive on time and in pristine condition.
This approach exposes the manufacturer, via their transport provider, to road haulage regulations that are extending across fleets.
Good distribution practice (GDP) guidelines (2013/C 343/01) are already in effect throughout Europe, together with the step-by-step adoption of the Falsified Medicines Directive 2011/62/EU and its derived regulations, which are scheduled to be fully implemented by February 2019. What are the three new directives of the EU Roadworthiness Package, and what are their implications for manufacturers?
The previous directive fixed the minimum standards for the regular vehicle checks that are required by law. The new directive extends the scope of this testing to include heavier vehicles.
This extension is due to the use of heavier vehicles, not previously covered, being used for commercial haulage, including within the pharmaceutical supplies sector.
While they present the same road risks as HGVs, until now they have not been included within the testing regime for commercial vehicles.
Vehicles designed for carriage of goods with a maximum mass (not exceeding 3.5t) are still exempt from EU rules on cabotage and drivers' hours, but they will now be subject to roadworthiness tests.
The first test will occur after four years and then every two years thereafter. However, high-mileage vehicles may be subject to more frequent testing.
Member states will move from carrying out purely random checking to adopting a more targeted approach. Under the new directive, the selection of vehicles will be based on the risk profile of the operators, targeting high risk enterprises so as to reduce the burden on those who maintain their vehicles properly.
Profiling will take into consideration the number and severity of defects of previous roadworthiness tests and roadside inspections (RSI).
Due to the lower regulatory burden, LCVs (under 3.5t) are being used more frequently, resulting in relatively high involvement in road traffic incidents. In 2013, there were 1,200 fatalities of the occupants of goods vehicles, with LCVs accounting for 75% of these.
Therefore, member states are encouraged to include LCVs in their inspection regime, including an initial check of the overall condition of the vehicle and its documentation, including the latest roadworthiness certificate and technical roadside inspection in paper or electronic form.
Based on the outcome, a more detailed inspection may be carried out, which may include the examination of brakes, tyres, wheels and so on.
Member states are required to verify that the person has certified knowledge and understanding relevant for road vehicles in the following areas:
- vehicle dynamics
- combustion engines
- material and material processing
- electronic vehicle components
- IT applications
- over three years' documented experience.
If manufacturers cannot demonstrate they performed due diligence, they are at risk of a penalty, warning or critical finding against them by the relevant regulatory body. It is imperative that you also keep up to date with any changes to the EU Roadworthiness Package as any changes will affect you.