Traducción de «medicamento dispensado sin receta médica » (Español → Inglés) :

medicinal product not subject to medical prescription | non-prescription drug | non-prescription medicinal product | OTC drug | OTC medicine | over-the-counter drug | over-the-counter medicine

ethical drug | medicinal product subject to medical prescription | prescription drug | prescription medicine | prescription only medicine | prescription-only medicinal product | Rx drug | POM [Abbr.]

over-the-counter drug [ non-prescription drug | non-prescription medicinal product | OTC drug | OTC medicine | over-the-counter medicine ]

non-prescription medicines | nonprescription medicines | medicines for self-medication | medicines used for self-treatment

manage a person's medication | manage a person's medicines | administer prescribed drugs | administer prescribed medication

over-the-counter drug [ OTC drug | over-the-counter medicine | OTC medicine | over-the-counter medication | OTC medication | over-the-counter remedy | non-prescription remedy | non-prescription medication | nonprescription drug ]

(o) safety features making it possible to ascertain identification, authenticity and traceability of medicinal products subject to medical prescription as defined in Title VI, other than radiopharmaceuticals and medicinal products which due to their specific characteristics are not suitable for distribution through a wholesaler and pharmacy and therefore are sold directly by the producer to a clinical establishment where they are directly administered to the patient; safety features may be applied, on the basis of a case-by-case analysis, to non-prescription medicinal produc ...[+++]ts where the risk related to the product indicates, on the basis of the criteria set out in Article 54a(4), that there are reasonable grounds for considering that the product may be falsified.

However, in view of the risk of falsification and the risk arising from falsification of medicinal products or categories of medicinal products there should be the possibility to exclude certain medicinal products or categories of medicinal products subject to prescription from the requirement to bear the safety features by way of a delegated act, following a risk assessment.

the lists containing the medicinal products or product categories which, in the case of medicinal products subject to prescription shall not bear the safety features, and in the case of medicinal products not subject to prescription shall bear the safety features referred to in point (o) of Article 54.

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 pharmacy 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.