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Quality across the product lifecycle The role of standards goes far beyond the drug manufacturing process – from the sourcing of raw materials to packaging, labeling, distribution, and point-of-care administration – to help ensure quality across the pharmaceutical product lifecycle.
Quality standards and related tools – supported by appropriate regulatory capability and enforcement – can help promote quality across the pharmaceutical product lifecycle, from the sourcing of active and inactive ingredients to packaging, labeling, distribution, and point-of-care administration.
With this extensive system in place, patients can trust that medicines with the same name will be consistent in quality no matter who manufactures it or where in the world it is made. Since manufacturers know the precise quality specifications, standards help make the approval process for genericmedicines more efficient.
This is due to the regulatory requirements imposed on parallel imported medicinal products in various Member States, the fulfilment of which often requires repackaging. Repackaging a medicinal product… means that the trademark is reapplied by an entity other than the trademark proprietor.”
These include allowing the exceptional supply of certain medicines that may not be authorised in a particular Member State or granting full or partial exemptions to certain labelling and packaging requirements to address severe problems in respect of the availability of some medicines.”
Certain groups of individuals may then not trust that the medicines have been produced with them in mind and may be highly sceptical of the resulting evidence base and prescribing label of medicines. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and genericmedicines.
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