The directive introduces obligatory safety features for all prescriptive medicinal products and a rapid alert system; harmonised safety features to verify authenticity and identify individual packs, providing tampering evidence for medicinal products subject to prescription (possible exclusion of certain products following a risk assessment); no safety features for medicinal products not subject to prescription, unless a risk assessment demonstrates the risk of falsification and consequently a threat to public health; traceability: there will be a unique identifier for the safety features (e.g. a serialisation number) which allows the authenticity of the product and individual packs to be verified throughout the supply chain up to pharma ...[+++]cy level; in addition, Member States have to set up systems to prevent suspected medicinal products from reaching patients; Internet sales: conditions for the supply of medicinal products to the public are determined by Member States; increased transparency as regards wholesale distributors; penalties applicable to infringements of national provisions must be applied.

When removing, replacing or covering the safety feature, this point should also be applicable to the new safety feature, unless the primary safety feature is a covert one and therefore cannot be recognised;

In case of boil off system in parallel of the primary safety device, then the safety valve shall be a category B safety device otherwise it shall be a category A safety device according to EN 13648.

4. ‘pyrotechnic article for vehicles’ means the components of an automotive safety device which contain pyrotechnic substances and which are used to activate safety devices or other devices in vehicles.

"IT Network Security Features" include the IT system security features of individual IT systems comprising the network together with those additional components and features associated with the network as such (for example, network communications, security identification and labelling mechanisms and procedures, access controls, programs and audit trails) needed to provide an acceptable level of protection for classified information.

If an appliance is equipped with safety and controlling devices, the functioning of the safety devices must not be overruled by that of the controlling devices.